Female Sexual Dysfunction

During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, the education of physicians regarding the examination and treatment of women for sexual dysfunction has been and remains, even now in 2024, much less thorough than for men. 

Not convinced? Let’s take a quick tour.
 

The New Sexual Revolution and the Growing Anger

Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.

I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.

She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”

I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.

That social revolution rages, still.

You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
 

The Lag in Sexual Education

To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD. 

When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.

I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”

All hands will go up.

Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”

Not once has anyone raised a hand.
 

The Sex Remedies Gap

When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three. 

Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia. 

The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.

I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
 

Historical Perspective

In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.

Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone. 

One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
 

Premenopausal Women: An Orphan Population

The concept of “orphan populations” can partially explain the gap in available therapies between men and women.

Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men. 
 

What Can Be Done?

The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.

First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.

Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.

Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.

Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here. 

Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.

Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.

During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, the education of physicians regarding the examination and treatment of women for sexual dysfunction has been and remains, even now in 2024, much less thorough than for men. 

Not convinced? Let’s take a quick tour.
 

The New Sexual Revolution and the Growing Anger

Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.

I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.

She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”

I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.

That social revolution rages, still.

You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
 

The Lag in Sexual Education

To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD. 

When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.

I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”

All hands will go up.

Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”

Not once has anyone raised a hand.
 

The Sex Remedies Gap

When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three. 

Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia. 

The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.

I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
 

Historical Perspective

In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.

Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone. 

One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
 

Premenopausal Women: An Orphan Population

The concept of “orphan populations” can partially explain the gap in available therapies between men and women.

Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men. 
 

What Can Be Done?

The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.

First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.

Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.

Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.

Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here. 

Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.

Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.

During the month of September, Sexual Health Awareness Month, it may help to notice something: Men and their doctors have significantly more options to help with sexual function than do women and their clinicians. Moreover, the education of physicians regarding the examination and treatment of women for sexual dysfunction has been and remains, even now in 2024, much less thorough than for men. 

Not convinced? Let’s take a quick tour.
 

The New Sexual Revolution and the Growing Anger

Around the time of the release of the book and movie Fifty Shades of Grey, Newsweek put the cultural sensation on its cover.

I bought the magazine at the airport and, while waiting for my plane, showed the story to a woman sitting next to me. “What do you think — is this the new ‘sexual revolution’?” I asked her.

She glanced at the cover and answered as accurately as if she had written the article: “In the ’60s, it became okay for women to have sex; now, it’s okay for women to demand good sex.”

I would add to that: Women are demanding good sex, and they want to define for themselves what “good” means.

That social revolution rages, still.

You would think that the demand would bring a corresponding response in clinical medicine. You would be wrong. Although efforts in some sectors are heroic, overall, the results are lagging the forward movement of women wanting better sex.
 

The Lag in Sexual Education

To examine the progression of the education of physicians regarding the treatment of female sexual dysfunction (FSD), Codispoti and colleagues examined the curricula of seven medical schools in and around Chicago. They found the following: Only one institution identified all anatomic components of the clitoris — one! Four of the seven discussed the physiology of the female orgasm. Only three of the seven highlighted the prevalence and epidemiology of FSD or the treatments for FSD. Only one of the seven explained how to do a genitourinary physical exam specific to assessing FSD. 

When assessing obstetrics and gynecology clinical materials, sexual pleasure, arousal, and libido were not included anywhere in the curricula.

I have been teaching physicians about the therapies I developed (over 5000 clinicians in 50-plus countries over the past 14 years). During those sessions, I often stop the class and ask, “Who in here was taught how to retract the foreskin and examine the penis for phimosis?”

All hands will go up.

Then I will ask, “Who in here was taught in medical school how to retract the clitoral hood and examine the clitoris for phimosis?”

Not once has anyone raised a hand.
 

The Sex Remedies Gap

When I first published research offering support for using platelet-rich plasma to improve sexual function in women, women had not one drug approved by the US Food and Drug Administration (FDA) for the treatment of sexual dysfunction — none. Men had over 20. Today, men have a growing number of FDA-approved drugs for erectile dysfunction, including the “fils”; women have three. 

Women have access to only one FDA-approved medication that primarily affects the genitalia: prasterone. This drug is indicated only for the treatment of pain in postmenopausal women. It does not directly enhance desire or improve orgasms. Said another way, although the incidence of sexual dysfunction is higher in premenopausal women than in other groups, they do not have a single approved medication designed to improve the function of their genitalia. 

The other two of the three available drugs — flibanserin and bremelanotide — primarily affect the brain and could accurately be called psychoactive agents. They are available only for premenopausal women to improve desire. Flibanserin resulted in one extra sexual encounter per month on average, and patients are advised to avoid alcohol while using the drug. The other can make you vomit.

I do think all three of these treatments can be of great help to some women. I am not advising their disappearance. But in contrast to what is available to men, they are woefully inadequate.
 

Historical Perspective

In 1980, the medical establishment believed “most instances of acquired impotence are psychogenic.” Then, with the accidental discovery of the benefits of phosphodiesterase type 5 inhibitors, we realized that most cases of male sexual dysfunction involve the vasculature of the genitalia, not the neuroses of the brain. Yet, our two FDA-approved drugs for women with sexual dysfunction are designed to affect the brain. Women have nothing but off-label therapies to improve the function of the genitalia.

Despite the fact research supports the use of testosterone in women for both libido and orgasm, and despite the fact millions of women are treated with testosterone off-label for the benefit of sexual function, the only widely used FDA-approved class of drugs for women that affects testosterone — birth control pills, by blocking pituitary hormone production (the way they prevent pregnancy) — lowers the production of testosterone. 

One might wonder, considering our expanded understanding of the endocrinology of both men and women, at the irony of why it is acceptable to lower the testosterone level of an adolescent girl knowingly, as if her development did not require the hormone (such would never be acceptable in an adolescent male unless sexual transitioning were the goal); yet, we are fearful of giving testosterone to grown women who can no longer make it.
 

Premenopausal Women: An Orphan Population

The concept of “orphan populations” can partially explain the gap in available therapies between men and women.

Women of childbearing age are risky to study; so, with testosterone, for example, it is safer and cheaper for pharmaceutical companies to prove the benefits for men and ride the profits from the off-label use for women. I don’t mean to condemn the manufacturers of testosterone, only to point out the phenomenon of why up to 30% of the prescriptions written by a primary care physician are off-label; off-label use is common among cardiologists (46%); up to 90% of children in the hospital receive at least one off-label drug; and approval of drugs for premenopausal women is more expensive than approval of drugs for men. 
 

What Can Be Done?

The regrettable situation does not reflect evil intent on the part of regulators, educators, or physicians. But the gap between what women want and what medical education and the pharmaceutical-regulatory complex are providing is intolerably wide.

First, I would recommend a standard, required curriculum for the study of female sexual anatomy and function be established and widely adopted by medical schools. The reproductive system contains different components and a different purpose from the orgasm system, with modest overlap. Both systems should be taught in every medical school.

Second, physicians should be required to undergo a course in understanding their own sexuality. Research demonstrates doctors will avoid conversations about sex, and it seems to me this could be secondary to being uncomfortable with their own sexuality. After all, to talk with a patient about sex, you cannot be fearful of where the conversation may lead.

Third, the FDA might reconsider the requirements for the approval of drugs for FSD. Currently, to approve a drug for men, an objective finding — ie, an erection — can be sufficient. However, a higher bar, “satisfaction,” which is subjective, must be obtained with women.

Regenerative therapies have proved helpful but are not yet widely adopted; more grant money for the study of regenerative therapies would be a good start here. 

Finally, by the definition of FSD, a woman must be psychologically distressed. The idea of sex is not pleasure alone. Sexual function affects family relationships, emotional health, confidence, even sleep, as well as the emotional well-being of the children who live in the house. Saying women are wonderfully and mysteriously made may be poetic, but it is not an excuse for not learning more and closing the gaps.

Dr. Runels is medical director of the Cellular Medicine Association, Fairhope, Alabama. He reported conflicts of interest with the Cellular Medicine Association, Runels Research Institute, Institute for Lichen Sclerosus, and Vulvar Health. A version of this article first appeared on Medscape.com.

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

The use of menopausal hormone therapy (MHT) increases breast cancer risk in women with a strong family history of breast cancer. These women have a striking cumulative risk of developing breast cancer (age, 50-80 years) of 22.4%, according to a new modelling study of UK women.

METHODOLOGY:

This was a modeling study integrating two data-sets of UK women: the BOADICEA dataset of age-specific breast cancer risk with family history and the Collaborative Group on Hormonal Factors in Breast Cancer, which covers relative risk for breast cancer with different types and durations of MHT.

Four different breast cancer family history profiles were:

• “Average” family history of breast cancer has unknown affected family members;
• “Modest” family history comprises a single first-degree relative with breast cancer at the age of 60 years.
• “Intermediate” family history comprises a single first-degree relative who developed breast cancer at the age of 40 years.
• “Strong” family history comprises two first-degree relatives who developed breast cancer at the age of 50 years.

TAKEAWAY:

• The lowest risk category: “Average” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 9.8% and a risk of dying from breast cancer of 1.7%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 11.0% and 1.8%, respectively.
• The highest risk category: “Strong” family history with no MHT use has a cumulative breast cancer risk (age, 50-80 years) of 19.6% and a risk of dying from breast cancer of 3.2%. These risks rise with 5 years’ exposure to MHT (age, 50-55 years) to 22.4% and 3.5%, respectively.

IN PRACTICE:

The authors concluded that, “These integrated data will enable more accurate estimates of absolute and attributable risk associated with MHT exposure for women with a family history of breast cancer, informing shared decision-making.”

SOURCE:

The lead author is Catherine Huntley of the Institute of Cancer Research, London, England. The study appeared in the British Journal of General Practice.

LIMITATIONS:

Limitations included modeling study that did not directly measure individuals with combined risks.

DISCLOSURES:

The study was funded by several sources including Cancer Research UK. The authors reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.

This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.

Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.

Sexual dysfunction is a common and significant late effect among CCS. The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
 

Characteristics and Mechanisms

Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.

As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.

Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.

Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects. 
 

Sexual Function in CCS

A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.

The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.

Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.

In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.

The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
 

Factors Influencing Sexual Function

The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.

Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.

Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.

Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.

The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.

Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.

Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.

Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
 

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

A version of this article first appeared on Medscape.com.

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

A version of this article first appeared on Medscape.com.

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

A version of this article first appeared on Medscape.com.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.

Five experts discussed research that they considered to be highlights of the European Society of Medical Oncology (ESMO) Breast Cancer annual congress during a “Key Takeaways” session at the meeting.

Among the topics the speakers addressed were breast cancer prevention, early breast cancer, advanced breast cancer, and supportive care.

In recent years, the way clinicians look at carcinogenesis in breast cancer has changed, and many new targets for potential early detection and prevention have emerged, said Suzette Delaloge, MD, of Gustave Roussy, Paris, France, in her presentation at the meeting.

Instant risk assessment at different time points could potentially intercept cancer among high-risk individuals, she said.

A study by Mikael Eriksson, PhD, and colleagues focused on external validation of the Profound AI tool to identify breast cancer risk in the general population. The researchers showed an area under the curve of 0.72 in their AI risk model, which has the potential to be clinically meaningful, although it must be prospectively validated, Dr. Delaloge said in her presentation.

She also reviewed two studies on the use of genes to further refine breast cancer risk among carriers. One of these, a prospective study presented in a session by Kelly-Anne Phillips, MD, of Peter MacCallum Cancer Center, Melbourne, Australia, used the CANRISK online risk assessment tool and validated increased breast cancer risk in BRCA1 and BRCA2 carriers, with AUCs of 0.79 and 0.78, respectively. The other study, which was by Maria Rezqallah Aron, MD, and colleagues examined polygenic scores as a way to refine breast cancer risk stratification among carriers of the ALM and PALB2 genes as well. These genes might be useful in identifying individuals who could benefit from early intervention, including surgery, Dr. Delaloge said.
 

Translational Research

“Preparing my talk, I felt like a kid in a candy store,” because of the amount of new translational research presented, including several studies of endocrine treatment–based approaches to therapy, said Marleen Kok, MD, of the Netherlands Cancer Institute, Amsterdam.

In her presentation, Dr. Kok highlighted findings from an analysis of patients in the monarchE study (a trial of high-risk patients) showing a consistent improvement in invasive disease-free survival for the subset of patients with germline BRCA1 and BRCA2 mutations who received abemaciclib plus endocrine therapy.

The value of tumor-infiltrating lymphocytes (TILs) on patients who are not receiving chemotherapy is important because of the focus on prognosis, and prospective trials are underway, she said.

A poster on the impact of chemotherapy and stromal tumor-infiltrating lymphocytes (sTILs) in stage I triple-negative breast cancer showed no association between chemotherapy and better outcomes regardless of sTILs in patients who did and did not receive chemotherapy, which has implications for potential treatment sparing in this population, Dr. Kok noted.

Artificial Intelligence (AI) was the subject of several posters at the meeting, and Dr. Kok identified a multisite European study of an automated HER2 scoring system as notable for its size and accuracy. In the study, the accuracy among pathologists was much higher with the assistance of AI, she said. Using AI for more complex analysis has shown success, she said.

Dr. Kok ended her talk with a poster that surveyed breast cancer patients about their understanding of their disease. The results showed that less than half (44%) of patients reported that their healthcare providers had given them enough information to learn about their breast cancer type, and less than one third could recall terminology about biomarkers; the study is important because it shows that clinicians need to do better in explaining these terms to patients, Dr. Kok said.
 

Early Breast Cancer

Right-sizing therapy, meaning identifying the right treatment for every patient, is a key element of new research in early breast cancer, said Erika Hamilton, MD, of the Sarah Cannon Research Institute, Nashville, Tenn.

She highlighted safety and treatment duration updates from the NATALEE study, which compared adjuvant ribociclib plus nonsteroidal aromatase inhibitor (NSAI) to NSAI alone for ER+/HER2- breast cancer. The current analysis presented at the meeting showed significant benefits with the addition of ribociclib and no evidence of new safety signals or adverse event exacerbations at 3 years, she said. Dose modifications had no significant impact on efficacy, she added.

The findings of no impact of dose reduction on efficacy in both the NATALEE and monarchE studies provide important information on whether dosage can be reduced in patients, which will increase the odds that patients will tolerate extended therapy with good outcomes and stay on their prescribed therapies, Dr. Hamilton emphasized.

The CARABELA study, a phase 2 trial of neoadjuvant letrozole plus abemaciclib vs adriamycin and cyclophosphamide (AC), showed clinically similar response rates but did not meet its endpoint for residual cancer burden (RCB) scores. These data add to results from other studies and show that it is too soon to universally replace neoadjuvant chemotherapy as first-line treatment for highly proliferative ER+ breast cancer, Dr. Hamilton said in her presentation.
 

Advanced Breast Cancer

Take-home messages about advanced breast cancer include growing evidence for the potential benefits of antibody drug conjugates (ADCs), said Eva Ciruelos, MD, of University Hospital, Madrid, Spain. The TROPION-BREAST01 study, a phase 3 randomized trial, showed significant and clinically meaningful improvement in progression-free survival in patients with previously treated, inoperable, or metastatic HR+/HER2- breast cancer who received datopotamab deruxtecan (Dato-DXd) compared with those who received chemotherapy.

Data from an additional safety analysis were presented at the meeting; although Dato-DXd, a trophoblast cell-surface antigen 2 (TROP2)–directed antibody-drug conjugate, was well-tolerated, it is important to remain aware of toxicities, notably oral mucositis, which occurred in 55.6% of the patients in the study across all grades, and ocular surface toxicity, which occurred in 40% of patients across all grades, Dr. Ciruelos emphasized.

Key research in the area of advanced triple-negative breast cancer included data from the IMPASSION 132 study. This study is “specifically centered on early relapsers,” a population often excluded from other trials, Dr. Ciruelos said. In this study, patients with advanced triple-negative breast cancer were randomized to chemotherapy with or without atezolizumab, and the study showed no benefits with atezolizumab for overall survival, progression-free survival, or overall response rate, she said. “This is something to work with, because this is a very refractory population,” Dr. Ciruelos noted.

New immunotherapy combinations are needed to improve survival in advanced breast cancer patients, Dr. Ciruelos said. At the meeting, researchers presented interim data from a subset of patients in the MORPHEUS-pan breast cancer trial, a phase 1B/2 study involving multiple treatment combinations in locally advanced/metastatic breast cancer patients.

The interim analysis included 18-week data from triple-negative breast cancer patients and compared outcomes for patients randomized to atezolizumab with or without sacituzumab govitecan (SG).

The study was small, with only 31 patients in the combination arm and 11 controls, but the results were promising, with an overall response rate of 76.7% in the combination arm vs 66.7% in the control arm, Dr. Ciruelos said.

Supportive Care

Key supportive care takeaways included data on pregnancy in young breast cancer survivors and the safety of vaginal estrogen therapy in breast cancer patients with genitourinary symptoms, said Anne May, MD, of the University Medical Center Utrecht, Utrecht, Netherlands.

A study previously published in JAMA including nearly 5000 BRCA carriers who were diagnosed with invasive breast cancer at age 40 years or younger showed no association between pregnancy after breast cancer and adverse maternal or fetal outcomes, and pregnancy had no significant impact on overall survival. The authors presented new data on the safety of assisted reproductive techniques (ART) based on the 543 pregnancies in the original study, at the meeting. Of these, 436 conceived naturally, and 107 used ART. After a median of 9.1 years, ART had no effect on disease-free survival compared to natural conception (hazard ratio [HR], 0.64). Based on these findings, fertility preservation should be offered to all women who receive a breast cancer diagnosis and are interested in future fertility, Dr. May said.

Conceiving after breast cancer treatment and follow-up should not be contraindicated for young BRCA carriers, she added.No trial data are available for the effects of vaginal estrogen therapy (VET) on disease-free survival in breast cancer survivors with genitourinary symptoms caused by declining estrogen levels, Dr. May said. However, researchers in France and Switzerland conducted an emulation of a hypothetical target trial using data from the French National social security system for more than 130,000 individuals. Although VET therapy had no impact on disease-free survival in most breast cancer survivors overall, it did have a negative impact in a subset of patients with HR-positive and HR-negative tumors who were treated with aromatase inhibitors. The study was hypothetical, but important because the results suggest that clinicians can safely propose VTE to patients who report genitourinary symptoms after treatment for early-stage breast cancer with tamoxifen, but VTE should be avoided in patients treated with aromatase inhibitors, Dr. May said.

Dr. Delaloge disclosed research support to her institution from AstraZeneca, MSD, Bristol Myers Squibb, Sanofi, Taiho, Novartis, European Commission, INCa, Banque des Territoires, and Fondation Philanthropia. She also disclosed honoraria to her institution from AstraZeneca, Gilead, Novartis, Elsan, Besins, Sanofi, Exact Sciences, and Lilly, as well as travel support from Novartis.

Dr. Kok disclosed research funding from AstraZeneca, Bristol Myers Squibb, Daichi, and Roche, and advisory board membership/speaker’s fees from Alderaan Biotechnology, BIONTECH, Domain Therapeutics, AstraZeneca, Daichi, Bristol Myers Squibb, Gilead, Medscape, MSD, and Roche.

Dr. Hamilton disclosed a consulting advisory role (to her institution) for Accutar Biotechology, AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Entos, Forsum Pharma, Gilead Sciences, Greenwich LifeSciences, Jazz Pharmaceuticals, Lilly, Medical Pharma Services, Mersana, Novartis, Olema Pharmaceuticals, Orum Therapeutics, Roche/Genentech, Stemline Therapeutics, ands others. She also disclosed contracted research/grant support to her institution only from Abbvie, Acerta Pharma, Accutar Biotechnology , ADC Therapeutics, AKESOBIO Australia , Amgen, Aravive, ArQule, Artios, Arvinas, AstraZeneca, AtlasMedx, BeiGene, Black Diamond and others.

Dr. Ciruelos disclosed serving as an external advisor for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, and Lilly, as well as serving as a speaker for Roche, MSD, Gilead, AstraZeneca, Daichii Sankyo, Reveal Genomics, Pfizer, Novartis, Lilly, and Pierre Fabre. She also disclosed travel grants from Roche, Pfizer, and AstraZeneca, and research grants from Seagen and Roche.

Dr. May had no financial conflicts to disclose.

Many women with cancer want advice for managing sexual function issues, and clinicians are tuning in, new studies suggest.

Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.

Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.

Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.

Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.

“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.

He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.

In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.

Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.

Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).

The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.

The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.

“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
 

Common Complaints and Causes

In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.

“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.

Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.

Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”

Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.

“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.

The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
 

Taking Sex Seriously

Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.

Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).

“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.

Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.

In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.

Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).

A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.

“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.

Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.

Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.

“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
 

Barriers and Solutions

Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.

Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.

“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.

Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.

Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.

Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.

Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.

Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.

For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.

Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.

Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.

“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.

Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.

Many women with cancer want advice for managing sexual function issues, and clinicians are tuning in, new studies suggest.

Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.

Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.

Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.

Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.

“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.

He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.

In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.

Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.

Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).

The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.

The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.

“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
 

Common Complaints and Causes

In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.

“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.

Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.

Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”

Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.

“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.

The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
 

Taking Sex Seriously

Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.

Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).

“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.

Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.

In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.

Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).

A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.

“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.

Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.

Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.

“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
 

Barriers and Solutions

Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.

Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.

“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.

Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.

Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.

Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.

Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.

Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.

For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.

Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.

Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.

“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.

Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.

Many women with cancer want advice for managing sexual function issues, and clinicians are tuning in, new studies suggest.

Decreased sexual function is a side effect of many types of cancer, notably uterine, cervical, ovarian, and breast cancer, that often goes unaddressed, according to the authors of several studies presented at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer.

Patients want to talk about sex, but not necessarily at the start of their diagnosis or treatment, suggest the findings of a study presented at the meeting. Jesse T. Brewer of Weill Cornell Medicine in New York City and colleagues enrolled 63 patients who underwent surgery with documented hereditary breast cancer, ovarian cancer, or Lynch syndrome in a cross-sectional survey.

Overall, 86% said that sexuality and intimacy were very or somewhat important, and 78% said that the healthcare team addressing the issue was very or somewhat important, the researchers found. However, only 40% of the respondents said that they wanted to discuss sexuality at the time of diagnosis because the idea was too overwhelming.

Oncologists are more aware of sexual side effects and the potential for sexual issues that persist long after treatment, but many patients may not have opportunities to talk about sexual concerns, said Don S. Dizon, MD, an oncologist specializing in women’s cancers at Brown University, Providence, Rhode Island, in an interview.

“It is important that we [oncologists] be the ones to open the door to these conversations; people with cancer will not bring it up spontaneously, for fear of making their provider uncomfortable, especially if they’ve never been asked about it before,” Dr. Dizon said in an interview.

He advised clinicians to find a network within their health systems so they can refer patients to specialized services, such as sex therapy, couples counseling, pelvic rehabilitation, or menopausal experts as needed.

In another study presented at the meeting, Naaman Mehta, MD, of NYU Langone Health, and colleagues reviewed data from 166 healthcare providers who completed a 23-item survey about evaluating and managing sexual health concerns of their patients. Most of the respondents were gynecologic oncologists (93.4%), but one radiation oncologist and 10 other healthcare providers also completed the survey.

Overall, approximately 60% of the respondents routinely asked about the sexual health concerns of their patients, and 98% of these said they believed that sexual health discussions should be held with a gynecologic oncologist. Just over half (54%) also said that the patient should be the one to initiate a discussion of sexual health concerns.

Female providers were significantly more likely to discuss sexual health with patients, compared with male providers, after controlling for the hospital setting and training level, the researchers noted (odds ratio, 1.4;P < .01).

The results suggest a need for more ways to integrate sexual health screening into gynecologic oncologic clinics, the researchers concluded.

The provider survey findings are similar to the results of a survey conducted by Dr. Dizon and colleagues in 2007. In that study, less than half of respondents took a sexual history, but 80% felt there was insufficient time to explore sexual issues.

“It is critical to understand that people with cancer do not expect their oncologists to be sexual health experts, but as with all other side effects caused by treatment and the diagnosis, we can be the ones who recognize it,” Dr. Dizon noted, in an interview.
 

Common Complaints and Causes

In Dr. Dizon’s experience, local symptoms including vaginal dryness, pain with penetration, and vaginal thinning, are common sexual complaints in women with cancer, as are systemic issues such as lack of interest and menopause-type symptoms.

“For those undergoing radiation, the vaginal tunnel can actually develop adhesions, and if not treated proactively this can lead to vaginal stenosis,” said Dr. Dizon, who was not involved in the studies presented at the meeting.

Comorbidities such as diabetes, cardiovascular disease, and musculoskeletal conditions can contribute to sexual issues in women with cancer, according to Nora Lersch, DNP, FNP-BC, AOCNP, and Nicole Dreibelbis, CRNP, the authors of other research presented at the meeting.

Culture, religion, fitness level, history of sexual violence, and gender spectrum health also play a role, as do anxiety and depression, dementia, and substance abuse disorders, the authors wrote in their presentation, “Prioritizing Sexual Health in Gynecological Oncology Care.”

Low libido is a frequent complaint across all cancer types, Ms. Dreibelbis, a nurse practitioner specializing in gynecologic oncology at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, said in an interview.

“Breast cancer patients, especially those on [aromatase inhibitor] therapy, often experience vaginal dryness and therefore dyspareunia,” she added.

The pelvic floor muscles, with their important role in sexual response, can be weakened by cancer treatment or surgery, and the pudendal nerves, which are the primary nerves responsible for sexual response in women, can be affected as well, Dr. Lersch and Ms. Dreibelbis wrote.
 

Taking Sex Seriously

Researchers are exploring the impact of different cancer prevention treatments for women to mitigate sexual side effects, as illustrated by another study presented at the meeting.

Dr. Barbara Norquist, MD, a gynecologic oncologist at the University of Washington, Seattle, and colleagues compared the sexual function and menopausal symptoms of patients at high risk of ovarian carcinoma who underwent either interval salpingectomy/delayed oophorectomy (ISDO) or risk-reducing salpingo-oophorectomy (RRSO).

“For patients at high risk for ovarian cancer, surgical removal of the tubes and ovaries is the mainstay of prevention, as screening is not effective at reducing death from ovarian cancer. As a result of surgery, many patients become suddenly postmenopausal from losing their ovaries,” Dr. Norquist said in an interview.

Some patients delay surgery out of concern for health and quality of life, including sexual function, she said.

In the study (known as the WISP trial) the researchers compared data from 166 patients who underwent immediate removal of the fallopian tubes and ovaries and 171 who underwent fallopian tube removal and delayed oophorectomy. All patients completed questionnaires about sexual function. The primary outcome was change in sexual function based on the sexual function index (FSFI) from baseline to 6 months after surgery.

Overall, changes in sexual function were significantly greater in the immediate oophorectomy group, compared with the delayed oophorectomy group at 6 months (33% vs 17%) and also at 12 months (43% vs 20%).

A further review of patients using hormone therapy showed that those in the immediate oophorectomy group still had greater decreases in sexual function, compared with the delayed group, though the difference between groups of patients using hormone therapy was less dramatic.

“I was surprised that, even with hormone replacement therapy, patients undergoing removal of the ovaries still had significant detrimental changes to sexual function when compared to those having the tubes removed, although this was even worse in those who could not take HRT,” Dr. Norquist said, in an interview. “I was reassured that menopausal symptoms in general were well managed with HRT, as these patients did not score differently on menopause symptoms, compared with those having their tubes removed,” she said.

Patients deserve accurate information about predicted changes in menopausal symptoms and sexual function as a result of ovary removal, and HRT should be provided when there is no contraindication, Dr. Norquist told this news organization.

Dr. Norquist and colleagues are awaiting the results of clinical trials investigating the safety of salpingectomy with delayed oophorectomy in terms of ovarian cancer prevention, but more research is needed to identify optimal management of the menopausal and sexual side effects associated with surgical menopause, she noted.

“Findings from the WISP study show the importance of hormones in women undergoing prophylactic surgery,” Dr. Dizon said. The findings indicate that salpingectomy has less of a negative influence on sexual function compared to removal of the ovaries, and the impact of hormone therapy and the relatively young age of the patients who took hormones reinforces current knowledge about hormones and sex, he added.
 

Barriers and Solutions

Barriers to asking women with cancer about sexual issues reported by providers include limited time, lack of training in sexual health, a desire to avoid offending the patient or making them uncomfortable, and uncertainty about how to answer the questions, Dr. Lersch and Ms. Dreibelbis wrote in their presentation.

Barriers to asking healthcare providers about their sexual issues reported by patients include the beliefs that the clinician should initiate the discussion, that sexual function will not be taken seriously, and that they might make the provider uncomfortable.

“Fortunately, more information and research has been done on sexual health and gynecological cancer in recent years, so oncologists are becoming more aware of the issues women may have,” said Dr. Lersch who is an oncology nurse practitioner at Providence Franz Cancer Institute in Portland, Oregon, in an interview.

Telling patients early in their cancer treatment about potential sexual side effects and opportunities for help is essential, she added.

Although oncologists have become more aware of the importance of sexual health and well-being for their patients, “I think there has historically been a disconnect in including sexual health education in medical training,” Ms. Dreibelbis said in an interview.

Dr. Lersch and Ms. Dreibelbis advised a multidimensional approach to managing sexual problems in cancer patients that includes consideration of biological and psychological symptoms, but also social, cultural, and interpersonal factors, in their presentation.

Their suggestions include discussing dyspareunia with their patients, asking for details such as whether the pain is internal or external, whether it occurs with activities outside of sex including masturbation, and whether bleeding is present.

Oncology therapies and surgeries can decrease or eliminate an individual’s ability to produce their own lubricant; for example, removal of the cervix eliminates cervical mucous, which helps with internal lubrication, they wrote in their presentation.

For patients with dyspareunia, Dr. Lersch and Ms. Dreibelbis recommend a vaginal moisturizer especially formulated for vaginal tissue that can be absorbed by the mucosal tissue of the vagina. Use of this type of product can increase the effectiveness of lubricants and help restore integrity of the vaginal tissue. Such moisturizers are available as gels, creams, or suppositories over the counter, and do not contain hormones.

Vaginal estrogen can be helpful for burning, itching, irritation, tissue fragility, and pain with sex, according to Dr. Lersch and Ms. Dreibelbis. Adequate estrogen therapy can promote normalization of vaginal pH and microflora, as well increase vaginal secretion and reduce pain and dryness with intercourse, the presenters stated in their presentation. In addition, dilator therapy can be used to help prevent vaginal stenosis, and penetration bumpers can help relieve discomfort during intercourse, they wrote.

Looking ahead, more research is needed to serve a wider patient population, Ms. Dreibelbis said, in an interview.

“LGBTQIA [individuals] have not been included in sexual health research and there are more people than ever who identify within this group of people. I know there has also been some very early work on shielding the clitoris from the impacts of radiation, and I believe this is extremely important up-and-coming research,” she said.

Dr. Lersch, Ms. Dreibelbi, Dr. Dizon, Dr. Norquist, Ms. Brewer, and Dr. Mehta had no financial conflicts to disclose.

Pelvic floor disorders are embarrassing, annoying, painful, and extremely disruptive to a woman’s life, often resulting in depression, anxiety, and a poor self-image. According to a 2021 study, approximately 75% of peripartum women and 68% of postmenopausal women feel insufficiently informed about pelvic floor disorders.¹

Consequently, a large majority of women are not seeking care for these disorders. This drives health care costs higher as women wait until their symptoms are unbearable until finally seeking help. Many of these women don’t know they have options.
 

Who is at risk?

To understand the scope of this growing problem, it is vital to see who is most at risk. Parity, age, body mass index, and race are significant factors, although any woman can have a pelvic floor disorder (PFD).

Urinary incontinence (UI), pelvic floor prolapses (POP), and fecal incontinence (FI) are three of the most common pelvic floor disorders. Pregnancy and childbirth, specifically a vaginal birth, greatly contribute to this population’s risk. In pregnancy, the increase in plasma volume and glomerular filtration rate, along with hormone changes impacting urethral pressure and the growing gravid uterus, cause urinary frequency and nocturia. This can result in urinary incontinence during and after pregnancy.

Indeed, 76% of women with urinary incontinence at 3 months postpartum report it 12 years later.¹ Third- and fourth-degree lacerations during delivery are uncommon (3.3%), but can cause fecal incontinence, often requiring surgery.¹ Independently, all of these symptoms have been correlated with sexual dysfunction and postpartum depression.

One-third of all women and 50% of women over the age of 55 are currently affected by a PFD. Contributing factors include hormone changes with menopause that affect the pelvic floor muscles and connective tissue, prior childbirth and pregnancy, constipation, heavy lifting, prior pelvic surgery, and obesity. These women are vulnerable to pelvic organ prolapse from the weakened pelvic floor muscles. They will often present with a vague complaint of “something is protruding out of my vagina.” These women also present with urinary incontinence or leakage, proclaiming they have to wear a diaper or a pad. Without proper knowledge, aging women think these issues are normal and nothing can be done.

The woman with a BMI above 30 may have damaged tissues supporting the uterus and bladder, weakening those organs, and causing a prolapse. Incontinence is a result of poor muscle and connective tissue of the vagina that support the urethra. Obese women can suffer from both urinary and bowel incontinence. By the year 2030, it is projected that one in two adults will be obese.² This will greatly impact health care costs.

To date, there is little conclusive evidence on the impact of race on pelvic floor disorders. A study in Scientific Reports did find that Asian women have a significantly lower risk for any PFD.² Some research has found that Black and Hispanic women have less risk for UI but are at higher risk for FI and other PFDs.³ Understandably, women of certain cultures and demographics may be less likely to report incontinence to their clinicians and may be less informed as well.
 

What can we do?

The American College of Obstetricians and Gynecologists (ACOG) has acknowledged the deficiencies and lack of standard care of pelvic health in pregnancy and postpartum.¹ There are differences in definitions across clinical practice and in the medical literature. Inconsistent patient reporting of PFD symptoms occurs due to nonstandard methods (questionnaire, interview, physical exam). With the often-short time allotted for visits with health care providers, women may neglect to discuss their symptoms, especially if they have other more pressing matters to address.

What would really help improve treatment of PFDs is early education in pregnancy. At the first OB appointment, a pregnant woman should be given information on what are normal and abnormal symptoms, from the beginning through postpartum. At each visit, she should be given ample opportunity to discuss symptoms of pelvic health. Clinicians should continue assessing, questioning, and discussing treatment options as applicable. Women need to know that early recognition and treatment can have a positive affect on their pelvic health for years to come.

ACOG recommends all postpartum patients see an obstetric provider within 3 weeks of delivery.¹ Most are seen at 6 weeks. Pelvic health should be discussed at this final postpartum appointment, including normal and abnormal symptoms within the next few months and beyond.

Regardless of pregnancy status, women need a safe and supportive place to describe their pelvic floor issues. There is a validated questionnaire tool available for postpartum, but one is desperately needed for all women, especially women at risk. A pelvic health assessment must be included in every annual exam.

Women need to know there are multiple treatment modalities including simple exercises, physical therapy, a variety of pessaries, medications, and surgery. Sometimes, all that is needed are a few lifestyle changes: avoiding pushing or straining while urinating or having a bowel movement, maintaining a healthy diet rich in high fiber foods, and drinking plenty of fluids.

The National Public Health Service in the United Kingdom recently announced a government-funded program for pelvic health services to begin in April 2024.⁴ This program will address the pelvic floor needs, assessment, education and treatment for women after childbirth.

There are multiple clinics in the United States focusing on women’s health that feature urogynecologists – specialists in pelvic floor disorders. These specialists do a thorough health and physical assessment, explain types of pelvic floor disorders, and suggest appropriate treatment options. Most importantly, urogynecologists listen and address a woman’s concerns and fears.

There is no reason for women to feel compromised at any age. We, as health care providers, just need to assess, educate, treat, and follow up.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

References

1. Madsen AM et al. Recognition and management of pelvic floor disorders in pregnancy and the postpartum period. Obstet Gynecol Clin North Am. 2021 Sep;48(3):571-84. doi: 10.1016/j.ogc.2021.05.009.

2. Kenne KA et al. Prevalence of pelvic floor disorders in adult women being seen in a primary care setting and associated risk factors. Sci Rep. 2022 June; (12):9878. doi: 10.1038/s41598-022-13501-w.

3. Nygaard I et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

4. United Kingdom Department of Health and Social Care. “National pelvic health service to support women.” 2023 Oct 19.

Pelvic floor disorders are embarrassing, annoying, painful, and extremely disruptive to a woman’s life, often resulting in depression, anxiety, and a poor self-image. According to a 2021 study, approximately 75% of peripartum women and 68% of postmenopausal women feel insufficiently informed about pelvic floor disorders.¹

Consequently, a large majority of women are not seeking care for these disorders. This drives health care costs higher as women wait until their symptoms are unbearable until finally seeking help. Many of these women don’t know they have options.
 

Who is at risk?

To understand the scope of this growing problem, it is vital to see who is most at risk. Parity, age, body mass index, and race are significant factors, although any woman can have a pelvic floor disorder (PFD).

Urinary incontinence (UI), pelvic floor prolapses (POP), and fecal incontinence (FI) are three of the most common pelvic floor disorders. Pregnancy and childbirth, specifically a vaginal birth, greatly contribute to this population’s risk. In pregnancy, the increase in plasma volume and glomerular filtration rate, along with hormone changes impacting urethral pressure and the growing gravid uterus, cause urinary frequency and nocturia. This can result in urinary incontinence during and after pregnancy.

Indeed, 76% of women with urinary incontinence at 3 months postpartum report it 12 years later.¹ Third- and fourth-degree lacerations during delivery are uncommon (3.3%), but can cause fecal incontinence, often requiring surgery.¹ Independently, all of these symptoms have been correlated with sexual dysfunction and postpartum depression.

One-third of all women and 50% of women over the age of 55 are currently affected by a PFD. Contributing factors include hormone changes with menopause that affect the pelvic floor muscles and connective tissue, prior childbirth and pregnancy, constipation, heavy lifting, prior pelvic surgery, and obesity. These women are vulnerable to pelvic organ prolapse from the weakened pelvic floor muscles. They will often present with a vague complaint of “something is protruding out of my vagina.” These women also present with urinary incontinence or leakage, proclaiming they have to wear a diaper or a pad. Without proper knowledge, aging women think these issues are normal and nothing can be done.

The woman with a BMI above 30 may have damaged tissues supporting the uterus and bladder, weakening those organs, and causing a prolapse. Incontinence is a result of poor muscle and connective tissue of the vagina that support the urethra. Obese women can suffer from both urinary and bowel incontinence. By the year 2030, it is projected that one in two adults will be obese.² This will greatly impact health care costs.

To date, there is little conclusive evidence on the impact of race on pelvic floor disorders. A study in Scientific Reports did find that Asian women have a significantly lower risk for any PFD.² Some research has found that Black and Hispanic women have less risk for UI but are at higher risk for FI and other PFDs.³ Understandably, women of certain cultures and demographics may be less likely to report incontinence to their clinicians and may be less informed as well.
 

What can we do?

The American College of Obstetricians and Gynecologists (ACOG) has acknowledged the deficiencies and lack of standard care of pelvic health in pregnancy and postpartum.¹ There are differences in definitions across clinical practice and in the medical literature. Inconsistent patient reporting of PFD symptoms occurs due to nonstandard methods (questionnaire, interview, physical exam). With the often-short time allotted for visits with health care providers, women may neglect to discuss their symptoms, especially if they have other more pressing matters to address.

What would really help improve treatment of PFDs is early education in pregnancy. At the first OB appointment, a pregnant woman should be given information on what are normal and abnormal symptoms, from the beginning through postpartum. At each visit, she should be given ample opportunity to discuss symptoms of pelvic health. Clinicians should continue assessing, questioning, and discussing treatment options as applicable. Women need to know that early recognition and treatment can have a positive affect on their pelvic health for years to come.

ACOG recommends all postpartum patients see an obstetric provider within 3 weeks of delivery.¹ Most are seen at 6 weeks. Pelvic health should be discussed at this final postpartum appointment, including normal and abnormal symptoms within the next few months and beyond.

Regardless of pregnancy status, women need a safe and supportive place to describe their pelvic floor issues. There is a validated questionnaire tool available for postpartum, but one is desperately needed for all women, especially women at risk. A pelvic health assessment must be included in every annual exam.

Women need to know there are multiple treatment modalities including simple exercises, physical therapy, a variety of pessaries, medications, and surgery. Sometimes, all that is needed are a few lifestyle changes: avoiding pushing or straining while urinating or having a bowel movement, maintaining a healthy diet rich in high fiber foods, and drinking plenty of fluids.

The National Public Health Service in the United Kingdom recently announced a government-funded program for pelvic health services to begin in April 2024.⁴ This program will address the pelvic floor needs, assessment, education and treatment for women after childbirth.

There are multiple clinics in the United States focusing on women’s health that feature urogynecologists – specialists in pelvic floor disorders. These specialists do a thorough health and physical assessment, explain types of pelvic floor disorders, and suggest appropriate treatment options. Most importantly, urogynecologists listen and address a woman’s concerns and fears.

There is no reason for women to feel compromised at any age. We, as health care providers, just need to assess, educate, treat, and follow up.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

References

1. Madsen AM et al. Recognition and management of pelvic floor disorders in pregnancy and the postpartum period. Obstet Gynecol Clin North Am. 2021 Sep;48(3):571-84. doi: 10.1016/j.ogc.2021.05.009.

2. Kenne KA et al. Prevalence of pelvic floor disorders in adult women being seen in a primary care setting and associated risk factors. Sci Rep. 2022 June; (12):9878. doi: 10.1038/s41598-022-13501-w.

3. Nygaard I et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

4. United Kingdom Department of Health and Social Care. “National pelvic health service to support women.” 2023 Oct 19.

Pelvic floor disorders are embarrassing, annoying, painful, and extremely disruptive to a woman’s life, often resulting in depression, anxiety, and a poor self-image. According to a 2021 study, approximately 75% of peripartum women and 68% of postmenopausal women feel insufficiently informed about pelvic floor disorders.¹

Consequently, a large majority of women are not seeking care for these disorders. This drives health care costs higher as women wait until their symptoms are unbearable until finally seeking help. Many of these women don’t know they have options.
 

Who is at risk?

To understand the scope of this growing problem, it is vital to see who is most at risk. Parity, age, body mass index, and race are significant factors, although any woman can have a pelvic floor disorder (PFD).

Urinary incontinence (UI), pelvic floor prolapses (POP), and fecal incontinence (FI) are three of the most common pelvic floor disorders. Pregnancy and childbirth, specifically a vaginal birth, greatly contribute to this population’s risk. In pregnancy, the increase in plasma volume and glomerular filtration rate, along with hormone changes impacting urethral pressure and the growing gravid uterus, cause urinary frequency and nocturia. This can result in urinary incontinence during and after pregnancy.

Indeed, 76% of women with urinary incontinence at 3 months postpartum report it 12 years later.¹ Third- and fourth-degree lacerations during delivery are uncommon (3.3%), but can cause fecal incontinence, often requiring surgery.¹ Independently, all of these symptoms have been correlated with sexual dysfunction and postpartum depression.

One-third of all women and 50% of women over the age of 55 are currently affected by a PFD. Contributing factors include hormone changes with menopause that affect the pelvic floor muscles and connective tissue, prior childbirth and pregnancy, constipation, heavy lifting, prior pelvic surgery, and obesity. These women are vulnerable to pelvic organ prolapse from the weakened pelvic floor muscles. They will often present with a vague complaint of “something is protruding out of my vagina.” These women also present with urinary incontinence or leakage, proclaiming they have to wear a diaper or a pad. Without proper knowledge, aging women think these issues are normal and nothing can be done.

The woman with a BMI above 30 may have damaged tissues supporting the uterus and bladder, weakening those organs, and causing a prolapse. Incontinence is a result of poor muscle and connective tissue of the vagina that support the urethra. Obese women can suffer from both urinary and bowel incontinence. By the year 2030, it is projected that one in two adults will be obese.² This will greatly impact health care costs.

To date, there is little conclusive evidence on the impact of race on pelvic floor disorders. A study in Scientific Reports did find that Asian women have a significantly lower risk for any PFD.² Some research has found that Black and Hispanic women have less risk for UI but are at higher risk for FI and other PFDs.³ Understandably, women of certain cultures and demographics may be less likely to report incontinence to their clinicians and may be less informed as well.
 

What can we do?

The American College of Obstetricians and Gynecologists (ACOG) has acknowledged the deficiencies and lack of standard care of pelvic health in pregnancy and postpartum.¹ There are differences in definitions across clinical practice and in the medical literature. Inconsistent patient reporting of PFD symptoms occurs due to nonstandard methods (questionnaire, interview, physical exam). With the often-short time allotted for visits with health care providers, women may neglect to discuss their symptoms, especially if they have other more pressing matters to address.

What would really help improve treatment of PFDs is early education in pregnancy. At the first OB appointment, a pregnant woman should be given information on what are normal and abnormal symptoms, from the beginning through postpartum. At each visit, she should be given ample opportunity to discuss symptoms of pelvic health. Clinicians should continue assessing, questioning, and discussing treatment options as applicable. Women need to know that early recognition and treatment can have a positive affect on their pelvic health for years to come.

ACOG recommends all postpartum patients see an obstetric provider within 3 weeks of delivery.¹ Most are seen at 6 weeks. Pelvic health should be discussed at this final postpartum appointment, including normal and abnormal symptoms within the next few months and beyond.

Regardless of pregnancy status, women need a safe and supportive place to describe their pelvic floor issues. There is a validated questionnaire tool available for postpartum, but one is desperately needed for all women, especially women at risk. A pelvic health assessment must be included in every annual exam.

Women need to know there are multiple treatment modalities including simple exercises, physical therapy, a variety of pessaries, medications, and surgery. Sometimes, all that is needed are a few lifestyle changes: avoiding pushing or straining while urinating or having a bowel movement, maintaining a healthy diet rich in high fiber foods, and drinking plenty of fluids.

The National Public Health Service in the United Kingdom recently announced a government-funded program for pelvic health services to begin in April 2024.⁴ This program will address the pelvic floor needs, assessment, education and treatment for women after childbirth.

There are multiple clinics in the United States focusing on women’s health that feature urogynecologists – specialists in pelvic floor disorders. These specialists do a thorough health and physical assessment, explain types of pelvic floor disorders, and suggest appropriate treatment options. Most importantly, urogynecologists listen and address a woman’s concerns and fears.

There is no reason for women to feel compromised at any age. We, as health care providers, just need to assess, educate, treat, and follow up.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

References

1. Madsen AM et al. Recognition and management of pelvic floor disorders in pregnancy and the postpartum period. Obstet Gynecol Clin North Am. 2021 Sep;48(3):571-84. doi: 10.1016/j.ogc.2021.05.009.

2. Kenne KA et al. Prevalence of pelvic floor disorders in adult women being seen in a primary care setting and associated risk factors. Sci Rep. 2022 June; (12):9878. doi: 10.1038/s41598-022-13501-w.

3. Nygaard I et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

4. United Kingdom Department of Health and Social Care. “National pelvic health service to support women.” 2023 Oct 19.

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.

Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).

At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.

Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.

• Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
• Advise. Make sure your patient knows many women struggle with the problem they have raised.
• Assess. Ask a set of standardized assessment questions.
• Assist. Tell your patient about treatment options.
• Arrange. Arrange a follow-up visit to see if treatment has been effective.

Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.

“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”

The 5As framework offers a helpful way to initiate those conversations, she said.
 

Medications might be to blame

Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.

“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”

For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women. 
 

Pharmacologic options

Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy. 

Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015. 

The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.

Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.

Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce. 

“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.

Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.

“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.

Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug. 

“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
 

Nonpharmacologic interventions

Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.

“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.

Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.

A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.

“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.

Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.

This article was produced for ProPublica’s Local Reporting Network in partnership with The Salt Lake Tribune.

At 19 years old and about to be married, Stephanie Mateer went to an ob.gyn. within walking distance of her student housing near Brigham Young University in Provo, Utah.

She wanted to start using birth control, and she was looking for guidance about having sex for the first time on her 2008 wedding night.

Ms. Mateer was shocked, she said, when David Broadbent, MD, reached under her gown to grab and squeeze her breasts, started a vaginal exam without warning, then followed it with an extremely painful examination of her rectum.

She felt disgusted and violated, but doubt also crept in. She told herself she must have misinterpreted his actions, or that she should have known that he would do a rectal exam. Raised as a member of The Church of Jesus Christ of Latter-day Saints, she said she was taught to defer to men in leadership.

“I viewed him as being a man in authority,” Ms. Mateer said. “He’s a doctor.”

It was years, she said, before she learned that her experience was in a sharp contrast to the conduct called for in professional standards, including that doctors use only their fingertips during a breast exam and communicate clearly what they are doing in advance, to gain the consent of their patients. Eventually, she gave her experience another name: sexual assault.

Utah judges, however, have called it health care.

And that legal distinction means Utahns like Ms. Mateer who decide to sue a health care provider for alleged sexual abuse are treated more harshly by the court system than plaintiffs who say they were harmed in other settings.

The chance to go to civil court for damages is an important option for survivors, experts say. While a criminal conviction can provide a sense of justice, winning a lawsuit can help victims pay for the therapy and additional support they need to heal after trauma.

Ms. Mateer laid out her allegations in a lawsuit that she and 93 other women filed against Dr. Broadbent last year. But they quickly learned they would be treated differently than other sexual assault survivors.

Filing their case, which alleged the Utah County doctor sexually assaulted them over the span of his 47-year career, was an empowering moment, Ms. Mateer said. But a judge threw out the lawsuit without even considering the merits, determining that because their alleged assailant is a doctor, the case must be governed by medical malpractice rules rather than those that apply to cases of sexual assault.

Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings – even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline.

“It’s just crazy that a doctor can sexually assault women and then be protected by the white coat,” Ms. Mateer said. “It’s just a really scary precedent to be calling sexual assault ‘health care.’ ”

Because of the judge’s ruling that leaves them with a shorter window in which to file, some of Dr. Broadbent’s accusers stand to lose their chance to sue. Others were already past that deadline but had hoped to take advantage of an exception that allows plaintiffs to sue if they can prove that the person who harmed them had covered up the wrongdoing and if they discovered they had been hurt within the previous year.

As a group, the women are appealing the ruling to the Utah Supreme Court, which has agreed to hear the case. This decision will set a precedent for future sexual assault victims in Utah.

Dr. Broadbent’s attorney, Chris Nelson, declined an interview request but wrote in an email: “We believe that the allegations against Dr. Broadbent are without merit and will present our case in court. Given that this is an active legal matter, we will not be sharing any details outside the courtroom.”

States have varying legal definitions of medical malpractice, but it’s generally described as treatment that falls short of accepted standards of care. That includes mistakes, such as a surgeon leaving a piece of gauze inside a patient.

Utah is among the states with the broadest definition of medical malpractice, covering any acts “arising” out of health care. The Utah Supreme Court has ruled that a teenage boy was receiving health care when he was allowed to climb a steep, snow-dusted rock outcrop as part of wilderness therapy. When he broke his leg, he could only sue for medical malpractice, so the case faced shorter filing deadlines and lower monetary caps. Similarly, the court has ruled that a boy harmed by another child while in foster care was also bound by medical malpractice law.

Despite these state Supreme Court rulings, Utah legislators have so far not moved to narrow the wording of the malpractice act.

The lawsuit against Dr. Broadbent – and the questions it raises about the broadness of Utah’s medical malpractice laws – comes during a national reckoning with how sexual assault survivors are treated by the law. Legislators in several states have been rewriting laws to give sexual assault victims more time to sue their attackers, in response to the growing cultural understanding of the impact of trauma and the barriers to reporting. Even in Utah, those who were sexually abused as children now have no deadline to file suits against their abusers.

That isn’t true for sexual abuse in a medical setting, where cases must be filed within 2 years of the assault.

These higher hurdles should not exist in Utah, said state Sen. Mike K. McKell, a Utah County Republican who works as a personal injury attorney. He is trying to change state law to ensure that sexual assault lawsuits do not fall under Utah’s Health Care Malpractice Act, a law designed to cover negligence and poor care, not necessarily deliberate actions like an assault.

“Sexual assault, to me, is not medical care. Period,” he said. “It’s sad that we need to clarify that sexual assault is not medical care. But trying to tie sexual assault to a medical malpractice [filing deadline] – it’s just wrong.”
 

‘Your husband is a lucky man’

Ms. Mateer had gone to Dr. Broadbent in 2008 for a premarital exam, a uniquely Utah visit often scheduled by young women who are members of The Church of Jesus Christ of Latter-day Saints.

Leaders of the faith, which is predominant in Utah, focus on chastity when speaking to young, unmarried people about sex, and public schools have typically focused on abstinence-based sex education. So for some, these visits are the first place they learn about sexual health.

Young women who get premarital exams are typically given a birth control prescription, but the appointments can include care that’s less common for healthy women in other states – such as doctors giving them vaginal dilators to stretch their tissues before their wedding nights.

That’s what Ms. Mateer was expecting when she visited Dr. Broadbent’s office. The ob.gyn. had been practicing for decades in his Provo clinic nestled between student housing apartments across the street from Brigham Young University, which is owned by The Church of Jesus Christ of Latter-day Saints.

So Ms. Mateer was “just totally taken aback,” she said, by the painful examination and by Dr. Broadbent snapping off his gloves after the exam and saying, “Your husband is a lucky man.”

She repeated that remark in her legal filing, along with the doctor’s advice for her: If she bled during intercourse, “just do what the Boy Scouts do and apply pressure.”

“The whole thing was like I’m some object for my husband to enjoy and let him do whatever he wants,” Ms. Mateer said. “It was just very violating and not a great way to start my sexual relationship with my new husband, with these ideas in mind.”

Ms. Mateer thought back to that visit over the years, particularly when she went to other ob.gyns. for health care. Her subsequent doctors, she said, never performed a rectal exam and always explained to her what they were doing and how it would feel, and asked for her consent.

She thought about Dr. Broadbent again in 2017, as the #MeToo movement gained momentum, and looked him up online. Ms. Mateer found reviews from other women who described Dr. Broadbent doing rough examinations without warning that left them feeling the same way she had years before.

Then in December 2021, she spoke out on “Mormon Stories,” a podcast where people who have left or have questioned their Latter-day Saint faith share their life stories. In the episode, she described the painful way he examined her, how it left her feeling traumatized, and her discovery of the reviews that echoed her experience.

“He’s on University Avenue, in Provo, giving these exams to who knows how many naive Mormon 18-year-old, 19-year-old girls who are getting married. … They are naive and they don’t know what to expect,” she said on the podcast. “His name is Dr. David Broadbent.”

After the podcast aired, Ms. Mateer was flooded with messages from women who heard the episode and reached out to tell her that Dr. Broadbent had harmed them, too.

Ms. Mateer and three other women decided to sue the ob.gyn., and in the following weeks and months, 90 additional women joined the lawsuit they filed in Provo. Many of the women allege Dr. Broadbent inappropriately touched their breasts, vaginas and rectums, hurting them, without warning or explanation. Some said he used his bare hand – instead of using a speculum or gloves – during exams. One alleged that she saw he had an erection while he was touching her.

Dr. Broadbent’s actions were not medically necessary, the women allege, and were instead “performed for no other reason than his own sexual gratification.”

The lawsuit also named as defendants two hospitals where Dr. Broadbent had delivered babies and where some of the women allege they were assaulted. The suit accused hospital administrators of knowing about Dr. Broadbent’s inappropriate behavior and doing nothing about it.

After he was sued, the ob.gyn. quickly lost his privileges at the hospitals where he worked. Dr. Broadbent, now 75, has also voluntarily put his medical license in Utah on hold while police investigate 29 reports of sexual assault made against him.

Prosecutors are still considering whether to criminally prosecute Dr. Broadbent. Provo police forwarded more than a dozen reports to the Utah County attorney’s office in November, which are still being reviewed by a local prosecutor.

A spokesperson for Intermountain Health, the nonprofit health system that owns Utah Valley Hospital, where some of the women in the suit were treated, did not respond to specific questions. The spokesperson emphasized in an email that Dr. Broadbent was an “independent physician” who was not employed by Utah Valley Hospital, adding that most of the alleged incidents took place at Dr. Broadbent’s medical office.

A representative for MountainStar Healthcare, another hospital chain named as a defendant, denied knowledge of any allegations of inappropriate conduct reported to its hospital and also emphasized that Dr. Broadbent worked independently, not as an employee.

“Our position since this lawsuit was filed has been that we were inappropriately named in this suit,” said Brittany Glas, the communications director for MountainStar.
 

Debating whether sexual abuse is health care

For the women who sued Dr. Broadbent, their case boiled down to a key question: Were the sexual assaults they say they experienced part of their health care? There was a lot hanging on the answer.

If their case was considered medical malpractice, they would be limited in how much money they could receive in damages for their pain and suffering. If a jury awarded them millions of dollars, a judge would be required by law to cut that down to $450,000. There’s no cap on these monetary awards for victims sexually assaulted in other settings.

They would also be required to go before a panel, which includes a doctor, a lawyer and a community member, that decides whether their claims have merit. This step, aimed at resolving disputes out of court, does not block anyone from suing afterward. But it does add cost and delay, and for sexual assault victims who’ve gone through this step, it has been another time they were required to describe their experiences and hope they were believed.

The shorter, 2-year filing deadline for medical malpractice cases can also be a particular challenge for those who have been sexually abused because research shows that it’s common to delay reporting such assaults.

Nationwide, these kinds of malpractice reforms were adopted in the 1970s amid concerns – largely driven by insurance companies – that the cost of health care was rising because of frivolous lawsuits and “runaway juries” doling out multimillion-dollar payouts.

Restricting the size of malpractice awards and imposing other limits, many argued, were effective ways to balance compensating injured patients with protecting everyone’s access to health care.

State laws are generally silent on whether sexual assault lawsuits should be covered by malpractice laws, leaving courts to grapple with that question and leading to different conclusions across the country. The Tribune and ProPublica identified at least six cases in which state appellate judges sharply distinguished between assault and health care in considering whether malpractice laws should apply to sexual assault–related cases.

An appellate court in Wisconsin, for example, ruled in 1993 that a physician having an erection and groping a patient was a purposeful harm, not medical malpractice.

Florida’s law is similar to Utah’s, defining allegations “arising” out of medical care as malpractice. While an earlier ruling did treat sexual assault in a health care setting as medical malpractice, appellate rulings in the last decade have moved away from that interpretation. In 2005, an appellate court affirmed a lower-court ruling that when a dentist “stopped providing dental treatment to the victim and began sexually assaulting her, his professional services ended.”

Similarly, a federal judge in Iowa in 1995 weighed in on the meaning of “arising” out of health care: “Rape is not patient care activity,” he wrote.

But Utah’s malpractice law is so broad that judges have been interpreting it as covering any act performed by a health care provider during medical care. The law was passed in 1976 and is popular with doctors and other health care providers, who have lobbied to keep it in place – and who use it to get lawsuits dismissed.

One precedent-setting case in Utah shows the law’s power to safeguard health care providers and was an important test of how Utah defines medical malpractice. Jacob Scott sued WinGate Wilderness Therapy after the teen broke his leg in 2015 when a hiking guide from the center allowed him to climb up and down a steep outcrop in Utah’s red rock desert.

His parents are both lawyers, and after they found that Utah had a 4-year deadline for filing a personal injury lawsuit, court records said, they decided to prioritize “getting Jacob better” for the first 2 years after the accident. But when Mr. Scott’s suit was filed, WinGate argued it was too late – based on the shorter, 2-year deadline for medical malpractice claims.

Mr. Scott’s attorneys scoffed. “Interacting with nature,” his attorneys argued, “is not health care even under the broadest interpretation of … the Utah Health Care Malpractice Act.”

A judge disagreed and threw out Mr. Scott’s case. The Utah Supreme Court unanimously upheld that ruling in 2021.

“We agree with WinGate,” the justices wrote, “that it was acting as a ‘health care provider’ and providing ‘health care’ when Jacob was hiking and rock climbing.”

Last summer, the women who had sued Dr. Broadbent and the two hospitals watched online as lawyers debated whether the abuse they allegedly suffered was health care.

At the hearing, attorneys for Dr. Broadbent and the hospitals argued that the women should have pursued a medical malpractice case, which required them to first notify Dr. Broadbent and the hospitals that they wanted to sue. They also argued to Judge Robert Lunnen that the case couldn’t move forward because the women hadn’t gone before a prelitigation panel.

Attorneys for Dr. Broadbent and the hospitals argued, one after the other, that the painful and traumatic exams the women described arose out of health care treatments.

“Accepting the allegations of the complaint as true – as we must for purposes of this proceeding – we have to assume that [Broadbent] did something that was medically unnecessary, medically inappropriate,” argued David Jordan, a lawyer for Intermountain Health.

“But it doesn’t change the fact that it’s an act performed to a patient, during the patient’s treatment,” he said. “Because that’s what the patient is doing in the doctor’s office. They’re there for treatment.”

The attorney team for the women pushed back. Terry Rooney argued that if Dr. Broadbent’s actions fell under medical malpractice laws, many women would be knocked out of the case because of the age of their claims, and those who remained would be limited in the amount of money in damages they could receive.

“That’s really what this is about,” he argued. “And so it’s troubling – quite frankly it’s shocking to me – that we’re debating heavily the question of whether sexual abuse is health care.”

The judge mulled the issue for months. Judge Lunnen wrote in a September ruling that if the allegations were true, Dr. Broadbent’s treatment of his patients was “insensitive, disrespectful and degrading.”

But Utah law is clear, he said. Malpractice law covers any act or treatment performed by any health care provider during the patient’s medical care. The women had all been seeking health care, Judge Lunnen wrote, and Dr. Broadbent was providing that when the alleged assaults happened.

Their lawsuit was dismissed.
 

‘I felt defeated’

Brooke, another plaintiff who alleges Dr. Broadbent groped her, remembers feeling sick on the June day she watched the attorneys arguing. She asked to be identified by only her first name for this story.

She alleges Dr. Broadbent violated her in December 2008 while she was hospitalized after experiencing complications with her first pregnancy.

The nearest hospital to her rural town didn’t have a special unit to take care of premature babies, and her doctors feared she might need to deliver her son 6 weeks early. So Brooke had been rushed by ambulance over a mountain pass in a snowstorm to Utah Valley Hospital.

Brooke and her husband were terrified, she said, when they arrived at the Provo hospital. Dr. Broadbent happened to be the doctor on call. With Brooke’s husband and brother-in-law in the room, Dr. Broadbent examined her late that evening, she said, listening to her chest with a stethoscope.

The doctor then suddenly grabbed her breasts, she recalled – his movements causing her hospital gown to fall to expose her chest. She recounted this experience in her lawsuit, saying it was nothing like the breast exams she has had since.

“It was really traumatizing,” she said. “I was mortified. My husband and brother-in-law – we just didn’t say anything about it because it was so uncomfortable.”

Brooke voiced concerns to the nurse manager, and she was assigned a new doctor.

She gave birth to a healthy baby a little more than a month later, at the hospital near her home.

Hearing the judge’s ruling 14 years later, Brooke felt the decision revealed how Utah’s laws are broken.

“I was frustrated,” she said, “and I felt defeated. … I thought justice is not on our side with this.”

If the Utah Supreme Court rules that these alleged sexual assaults should legally be considered health care, the women will likely refile their claims as a medical malpractice lawsuit, said their attorney, Adam Sorensen. But it would be a challenge to keep all 94 women in the case, he said, due to the shorter filing window. Only two women in the lawsuit allege that they were harmed within the last 2 years.

The legal team for the women would have to convince a judge that their claims should still be allowed because they only recently discovered they were harmed. But based on previous rulings, Mr. Sorensen believes the women will have a better chance to win that argument if the civil suit remained a sexual assault case.

Regardless of what happens in their legal case, the decision by Brooke and the other women to come forward could help change state law for victims who come after them.

Recently, Mr. McKell, the state senator, introduced legislation to clarify that civil lawsuits alleging sexual assault by a health care worker do not fall under Utah’s Health Care Malpractice Act.

“I don’t think it’s a close call. Sexual assault is not medical care,” he said. “I know we’ve got some bizarre rulings that have come down through our courts in Utah.”

Both an association of Utah trial lawyers and the Utah Medical Association, which lobbies on behalf of the state’s physicians, support this reform.

“We support the fact that sexual assault should not be part of health care medical malpractice,” said Michelle McOmber, the CEO for the Utah Medical Association. “Sexual assault should be sexual assault, regardless of where it happens or who’s doing it. Sexual assault should be in that category, which is separate from actual health care. Because it’s not health care.”

MountainStar doesn’t have a position on the bill, Ms. Glas said. “If the laws were to change via new legislation and/or interpretation by the courts, we would abide by and comply with those new laws.”

But lawmakers are running out of time. With only a short time left in Utah’s legislative session, state senate and house leaders have so far prioritized passing new laws banning gender-affirming health care for transgender youths and creating a controversial school voucher program that will provide taxpayer funds for students to attend private school.

Utah lawmakers were also expected to consider a dramatic change for other sexual assault victims: a bill that would remove filing deadlines for civil lawsuits brought by people abused as adults. But that bill stalled before it could be debated.

Brooke had been eager to share her story, she said, in hopes it would help the first four women who’d come forward bolster their lawsuit against Dr. Broadbent. She later joined the case as a plaintiff. She read in their lawsuit about one woman who complained about him to the same hospital 7 years before she did, and about another woman who said Dr. Broadbent similarly molested her 2 days after Brooke had expressed her own concern.

“That bothered me so much,” she said. “It didn’t have to happen to all these women.”

Brooke doubts she’ll get vindication in a courtroom. Justice for her, she suspects, won’t come in the form of a legal ruling or a settlement against the doctor she says hurt her years ago.

Instead, she said, “maybe justice looks like changing the laws for future women.”
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive the biggest stories as soon as they’re published.