OBG Management

Endometriosis, defined by the ectopic growth of functioning endometrial glands and stroma,^1,2 usually affects the peritoneal cavity. However, endometriosis has been identified in the pneumothorax, brain, and within the extraperitoneum, such as the abdominal wall.^1-3 Incidence of abdominal wall endometriosis can be up to 12%.^3-5 If patients report symptoms, they can include abdominal pain, a palpable mass, pelvic pain consistent with endometriosis, and bleeding from involvement of the overlying skin. Abdominal wall endometriosis can be surgically resected, with complete resolution and a low rate of recurrence.

In the following video, we review the diagnosis of abdominal wall endometriosis, including our imaging of choice, and treatment options. In addition, we illustrate a surgical technique for the excision of abdominal wall endometriosis in a 38-year-old patient with symptomatic disease. We conclude with a review of key surgical steps.

We hope that you find this video useful to your clinical practice.
>> Dr. Arnold P. Advincula, and colleagues

Vidyard Video

Endometriosis, defined by the ectopic growth of functioning endometrial glands and stroma,^1,2 usually affects the peritoneal cavity. However, endometriosis has been identified in the pneumothorax, brain, and within the extraperitoneum, such as the abdominal wall.^1-3 Incidence of abdominal wall endometriosis can be up to 12%.^3-5 If patients report symptoms, they can include abdominal pain, a palpable mass, pelvic pain consistent with endometriosis, and bleeding from involvement of the overlying skin. Abdominal wall endometriosis can be surgically resected, with complete resolution and a low rate of recurrence.

In the following video, we review the diagnosis of abdominal wall endometriosis, including our imaging of choice, and treatment options. In addition, we illustrate a surgical technique for the excision of abdominal wall endometriosis in a 38-year-old patient with symptomatic disease. We conclude with a review of key surgical steps.

We hope that you find this video useful to your clinical practice.
>> Dr. Arnold P. Advincula, and colleagues

Vidyard Video

Endometriosis, defined by the ectopic growth of functioning endometrial glands and stroma,^1,2 usually affects the peritoneal cavity. However, endometriosis has been identified in the pneumothorax, brain, and within the extraperitoneum, such as the abdominal wall.^1-3 Incidence of abdominal wall endometriosis can be up to 12%.^3-5 If patients report symptoms, they can include abdominal pain, a palpable mass, pelvic pain consistent with endometriosis, and bleeding from involvement of the overlying skin. Abdominal wall endometriosis can be surgically resected, with complete resolution and a low rate of recurrence.

In the following video, we review the diagnosis of abdominal wall endometriosis, including our imaging of choice, and treatment options. In addition, we illustrate a surgical technique for the excision of abdominal wall endometriosis in a 38-year-old patient with symptomatic disease. We conclude with a review of key surgical steps.

We hope that you find this video useful to your clinical practice.
>> Dr. Arnold P. Advincula, and colleagues

Vidyard Video

Lichen sclerosus

Lichen sclerosus is an inflammatory skin disease that primarily affects the genital and perianal skin of postmenopausal women. The mean age of onset is the mid- to late 50s; fewer than 15% of lichen sclerosus cases present in children.^1,2 Case 1 represents presentation of vulvar lichen sclerosus in a premenopausal woman, which is uncommon.

The classic presentation of lichen sclerosus is a well-defined white, atrophic plaque with a wrinkled surface appearance located on the vulva, perineum, and perianal skin. Less commonly, examination may reveal white papules and macules, pallor with overlying edema, or hyperpigmentation. Loss of labia minora tissue and phimosis of the clitoral hood also are often present in patients with untreated lichen sclerosus.

Additionally, secondary changes, such as erosions, fissuring, and blisters, can be seen on examination. The most frequent symptom associated with lichen sclerosus is intense itching of the affected area. Other symptoms include dyspareunia, dysuria, sexual dysfunction, and bleeding. Occasionally, lichen sclerosus is asymptomatic.¹ Like other autoimmune conditions, lichen sclerosus may persist indefinitely, highlighting the importance of effective treatment. 

How should we evaluate and treat patients with these symptoms?

Perform a skin biopsy and start treatment with very high–potency topical corticosteroid ointment daily for at least 6 weeks.

Skin biopsy. Definitive diagnosis of lichen sclerosus is made based on a skin biopsy. Because treatment can impact the interpretation of a skin biopsy, a biopsy is optimally performed prior to treatment initiation.

The patient in Case 1 underwent biopsy of the left labia majora. Results were consistent with early lichen sclerosus. The patient in Case 2 was reluctant to proceed with vulvar biopsy.

A biopsy specimen should be taken from the affected area that is most white in appearance.¹

Topical treatment. To induce remission, twice-daily application of very high–potency topical corticosteroid ointment to the affected area for at least 6 weeks is recommended. Once the skin color and texture have normalized, the topical corticosteroid strength (and frequency of application) can slowly be reduced to the lowest potency/frequency at which the patient remains in remission. Examples of very high–, high-, moderate-, and low-potency corticosteroid ointments are listed in the TABLE.

Follow-up. Evaluate the patient every 3 months until the topical steroid potency remains stable and the skin appearance is normal.

Treat early, and aggressively, to prevent complications

Early diagnosis and aggressive intervention are important in managing this disease process. If diagnosis and treatment are delayed, significant scarring and deformation of the vulva can occur.¹

Neoplastic transformation of lichen sclerosus into vulvar intraepithelial neoplasia and squamous cell carcinoma can occur (mean incidence, 2.8%). However, the literature reports significant variability in the incidence, ranging between 0% and 31%.³ Published reports support decreased scarring and future development of malignancies in patients who adhere to treatment recommendations.⁴

Symptoms resolved

In both cases described here, the patients were treated with clobetasol 0.05% ointment twice daily for 6 weeks. Both women reported complete resolution of pruritus after treatment. As can be seen in the posttreatment photo of the patient described in Case 1, her vulvar inflammation resolved (FIGURE 4).

These cases represent the varied exam findings in patients experiencing vulvar pruritus with early (Case 1) versus more advanced (Case 2) lichen sclerosus. In addition, they underscore that appropriate evaluation and management of lichen sclerosus can produce excellent treatment results.

Lichen sclerosus

Lichen sclerosus is an inflammatory skin disease that primarily affects the genital and perianal skin of postmenopausal women. The mean age of onset is the mid- to late 50s; fewer than 15% of lichen sclerosus cases present in children.^1,2 Case 1 represents presentation of vulvar lichen sclerosus in a premenopausal woman, which is uncommon.

The classic presentation of lichen sclerosus is a well-defined white, atrophic plaque with a wrinkled surface appearance located on the vulva, perineum, and perianal skin. Less commonly, examination may reveal white papules and macules, pallor with overlying edema, or hyperpigmentation. Loss of labia minora tissue and phimosis of the clitoral hood also are often present in patients with untreated lichen sclerosus.

Additionally, secondary changes, such as erosions, fissuring, and blisters, can be seen on examination. The most frequent symptom associated with lichen sclerosus is intense itching of the affected area. Other symptoms include dyspareunia, dysuria, sexual dysfunction, and bleeding. Occasionally, lichen sclerosus is asymptomatic.¹ Like other autoimmune conditions, lichen sclerosus may persist indefinitely, highlighting the importance of effective treatment. 

How should we evaluate and treat patients with these symptoms?

Perform a skin biopsy and start treatment with very high–potency topical corticosteroid ointment daily for at least 6 weeks.

Skin biopsy. Definitive diagnosis of lichen sclerosus is made based on a skin biopsy. Because treatment can impact the interpretation of a skin biopsy, a biopsy is optimally performed prior to treatment initiation.

The patient in Case 1 underwent biopsy of the left labia majora. Results were consistent with early lichen sclerosus. The patient in Case 2 was reluctant to proceed with vulvar biopsy.

A biopsy specimen should be taken from the affected area that is most white in appearance.¹

Topical treatment. To induce remission, twice-daily application of very high–potency topical corticosteroid ointment to the affected area for at least 6 weeks is recommended. Once the skin color and texture have normalized, the topical corticosteroid strength (and frequency of application) can slowly be reduced to the lowest potency/frequency at which the patient remains in remission. Examples of very high–, high-, moderate-, and low-potency corticosteroid ointments are listed in the TABLE.

Follow-up. Evaluate the patient every 3 months until the topical steroid potency remains stable and the skin appearance is normal.

Treat early, and aggressively, to prevent complications

Early diagnosis and aggressive intervention are important in managing this disease process. If diagnosis and treatment are delayed, significant scarring and deformation of the vulva can occur.¹

Neoplastic transformation of lichen sclerosus into vulvar intraepithelial neoplasia and squamous cell carcinoma can occur (mean incidence, 2.8%). However, the literature reports significant variability in the incidence, ranging between 0% and 31%.³ Published reports support decreased scarring and future development of malignancies in patients who adhere to treatment recommendations.⁴

Symptoms resolved

In both cases described here, the patients were treated with clobetasol 0.05% ointment twice daily for 6 weeks. Both women reported complete resolution of pruritus after treatment. As can be seen in the posttreatment photo of the patient described in Case 1, her vulvar inflammation resolved (FIGURE 4).

These cases represent the varied exam findings in patients experiencing vulvar pruritus with early (Case 1) versus more advanced (Case 2) lichen sclerosus. In addition, they underscore that appropriate evaluation and management of lichen sclerosus can produce excellent treatment results.

Lichen sclerosus

Lichen sclerosus is an inflammatory skin disease that primarily affects the genital and perianal skin of postmenopausal women. The mean age of onset is the mid- to late 50s; fewer than 15% of lichen sclerosus cases present in children.^1,2 Case 1 represents presentation of vulvar lichen sclerosus in a premenopausal woman, which is uncommon.

The classic presentation of lichen sclerosus is a well-defined white, atrophic plaque with a wrinkled surface appearance located on the vulva, perineum, and perianal skin. Less commonly, examination may reveal white papules and macules, pallor with overlying edema, or hyperpigmentation. Loss of labia minora tissue and phimosis of the clitoral hood also are often present in patients with untreated lichen sclerosus.

Additionally, secondary changes, such as erosions, fissuring, and blisters, can be seen on examination. The most frequent symptom associated with lichen sclerosus is intense itching of the affected area. Other symptoms include dyspareunia, dysuria, sexual dysfunction, and bleeding. Occasionally, lichen sclerosus is asymptomatic.¹ Like other autoimmune conditions, lichen sclerosus may persist indefinitely, highlighting the importance of effective treatment. 

How should we evaluate and treat patients with these symptoms?

Perform a skin biopsy and start treatment with very high–potency topical corticosteroid ointment daily for at least 6 weeks.

Skin biopsy. Definitive diagnosis of lichen sclerosus is made based on a skin biopsy. Because treatment can impact the interpretation of a skin biopsy, a biopsy is optimally performed prior to treatment initiation.

The patient in Case 1 underwent biopsy of the left labia majora. Results were consistent with early lichen sclerosus. The patient in Case 2 was reluctant to proceed with vulvar biopsy.

A biopsy specimen should be taken from the affected area that is most white in appearance.¹

Topical treatment. To induce remission, twice-daily application of very high–potency topical corticosteroid ointment to the affected area for at least 6 weeks is recommended. Once the skin color and texture have normalized, the topical corticosteroid strength (and frequency of application) can slowly be reduced to the lowest potency/frequency at which the patient remains in remission. Examples of very high–, high-, moderate-, and low-potency corticosteroid ointments are listed in the TABLE.

Follow-up. Evaluate the patient every 3 months until the topical steroid potency remains stable and the skin appearance is normal.

Treat early, and aggressively, to prevent complications

Early diagnosis and aggressive intervention are important in managing this disease process. If diagnosis and treatment are delayed, significant scarring and deformation of the vulva can occur.¹

Neoplastic transformation of lichen sclerosus into vulvar intraepithelial neoplasia and squamous cell carcinoma can occur (mean incidence, 2.8%). However, the literature reports significant variability in the incidence, ranging between 0% and 31%.³ Published reports support decreased scarring and future development of malignancies in patients who adhere to treatment recommendations.⁴

Symptoms resolved

In both cases described here, the patients were treated with clobetasol 0.05% ointment twice daily for 6 weeks. Both women reported complete resolution of pruritus after treatment. As can be seen in the posttreatment photo of the patient described in Case 1, her vulvar inflammation resolved (FIGURE 4).

These cases represent the varied exam findings in patients experiencing vulvar pruritus with early (Case 1) versus more advanced (Case 2) lichen sclerosus. In addition, they underscore that appropriate evaluation and management of lichen sclerosus can produce excellent treatment results.

The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.¹ However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.² In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.³ Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.⁴

Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.⁵ Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.

Survey results show lack of knowledge on risk factors

In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.

Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.

When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).

Further study needed on universal screening

The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.

The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.¹ However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.² In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.³ Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.⁴

Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.⁵ Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.

Survey results show lack of knowledge on risk factors

In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.

Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.

When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).

Further study needed on universal screening

The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.

The American College of Obstetricians and Gynecologists (ACOG) recommends risk-based screening for hepatitis C virus (HCV) infection during pregnancy.¹ However, the prevalence of HCV among pregnant women in the United States is on the rise. From 2009 to 2014, HCV infection present at delivery increased 89%.² In addition, the risk of an HCV-infected mother transmitting the infection to her baby is about 4% to 7% per pregnancy.³ Currently, the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases recommend universal HCV screening in pregnancy.⁴

Researchers at Tufts Medical Center in Boston, Massachusetts, a tertiary care center, presented survey findings on HCV screening among ObGyns at ACOG’s 2019 Annual Clinical and Scientific Meeting in Nashville, Tennessee.⁵ Katherine G. Koniares, MD, and colleagues sought to assess the opinions and clinical practices of ObGyns by emailing a 10-question electronic survey to providers. A total of 38 of 41 providers (93%) responded to the survey.

Survey results show lack of knowledge on risk factors

In response to the question, “Which pregnant patients do you believe should be screened for HCV,” 43.2% of providers stated “all pregnant women,” while 54.1% said “only pregnant women with risk factors for HCV.” A small percentage (2.7%) responded that they were not sure.

Providers also were asked which patients in their practice they screen for HCV. In response, 77.8% stated that they screen pregnant women for HCV based on risk factors, while 13.9% screen all pregnant patients for HCV; 8.3% do not screen for HCV.

When asked which risk factors providers use to screen patients for HCV, 42% to 85% said they screen for each indicated risk factor. Only 36% of providers, however, correctly identified all risk factors (for example, receiving blood products from donors who later tested positive for HCV; unexplained liver disease; and percutaneous/parenteral exposures in an unregulated setting, such as receiving tattoos outside a licensed parlor).

Further study needed on universal screening

The researchers assert that risk-based screening for HCV is not effective and that further research on universal HCV screening in pregnant patients is needed.

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Energy-based therapy use in gynecology dates back to the early 1970s, when ablative carbon dioxide (C02) lasers were employed to treat cervical erosions.¹ Soon after, reports were published on laser treatment for diethylstilbestrol-associated vaginal adenosis, laser laparoscopy for adhesiolysis, laser hysteroscopy, and laser genital wart ablation.² Starting around 2011, the first articles were published on the use of fractional C02 laser treatment for vulvovaginal atrophy.^3,4 Use of laser and light-based therapies to treat “vaginal rejuvenation” is now increasing at an annual rate of 26%. In a few years, North America is expected to be the largest market for vaginal laser rejuvenation. In 2016, more than 500,000 feminine rejuvenation procedures were performed in the United States, and it is estimated that more than 27,000 energy-based devices will be in operation by 2021.⁵

Clearly, there is considerable public interest and intrigue in office-based female genital cosmetic procedures. In 2018, the US Food and Drug Administration contacted 7 manufacturers of energy-based devices to request revision and clarification for marketing of these devices, since these technologies are neither cleared nor approved for cosmetic vulvovaginal conditions.⁶ The companies responded within 30 days.

In this article, we appraise the existing literature regarding the mechanism of action of energy-based therapies used in gynecology and review outcomes of their use in female genital cosmetic surgery.

Laser technology devices and how they work

LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. Laser devices are composed of 1) an excitable medium (gas, liquid, solid) needed to emit light, 2) an energy source to excite the medium, 3) mirrors to bounce the light back and forth, and 4) a delivery and cooling system (FIGURE 1).

The electromagnetic spectrum is the range of all the wavelengths of light, including visible light, radio waves, infrared light, ultraviolet light, x-rays, and gamma rays (FIGURE 2). Most lasers used for the treatment of vulvovaginal disorders, typically C02 and erbium:yttrium aluminum garnet (Er:YAG) lasers, involve the infrared wavelengths.

The basic principle of laser treatment is to match the wavelength of the laser with the absorption spectrum of the desired target—a chromophore such as hemoglobin, melanin, or water (FIGURE 3). In essence, light is absorbed by the chromophore (which in vulvar and vaginal tissues is mostly water) and transformed into heat, leading to target destruction. In a fractionated (or fractional) laser beam, the laser is broken up into many smaller beams that treat only portions of the treatment area, with areas of intact epithelium in between the treated areas. At appropriately low thermal denaturation temperatures (45° to 50°C), tissue regeneration can occur through activation of heat shock proteins and tissue growth factors, creating neocollagenesis and neovascularization.

Continue to: In dermatology, fractionated lasers...

In dermatology, fractionated lasers have been used in the treatment of hair removal, vascular and pigmented lesions, scars, wound healing, tattoo removal, warts, and actinic keratoses. For these conditions, the targeted chromophores are water, hemoglobin, melanosomes, and tattoo ink. The laser pulses must be shorter than the target tissue thermal relaxation times in order to avoid excess heating and collateral tissue damage. Choosing appropriate settings is critical to achieve selective heating, or destruction, of the target tissue. These settings include appropriate wavelengths, pulse durations, and fluence, which is energy delivered per unit area (typically, joules per square centimeter).

For gynecologic conditions, the lasers used are most often CO2, Er:YAG, and hybrid (which include ablative and nonablative wavelengths) devices. In the epithelium of the vagina and vulva, these lasers generally have a very shallow depth of optical penetration, on the order of 10 to 200 µm.

Radiofrequency-based devices emit focused electromagnetic waves

Radiofrequency systems use a wand to deliver radiofrequency energy to create heat within the subepithelial layers of vulvar and vaginal tissues, while the surface remains cool. These devices can use monopolar or bipolar energy (current) to create a reverse thermal gradient designed to heat the deeper tissues transepithelially at a higher temperature while a coolant protects the surface epithelium. Some wand technologies require multiple treatments, while others require only a single treatment.

The TABLE lists currently available energy-based technologies.

Therapeutic uses for energy-based devices

Investigators have studied laser devices for treating various gynecologic conditions, including vulvovaginal atrophy, stress urinary incontinence (UI), vaginal laxity, lichen sclerosus, and vulvodynia.

Vulvovaginal atrophy

Genitourinary syndrome of menopause (GSM) includes symptoms of vulvovaginal irritation, burning, itching, discharge, dyspareunia, lower urinary tract symptoms such as frequency and urinary tract infections, and vaginal dryness or vulvovaginal atrophy.⁷ First-line treatment for vulvovaginal atrophy includes the use of nonhormonal lubricants for intercourse and vaginal moisturizers, which temporarily moisten the vaginal epithelium. Low-dose vaginal estrogen is a second-line therapy for symptomatic vulvovaginal atrophy; newer pharmacologic options include dehydroepiandrosterone (DHEA) suppositories (prasterone), solubilized estradiol capsules, and the selective estrogen receptor modulator (SERM) ospemifene.

Fractionated CO2, Erb:YAG, and hybrid lasers also have been used to treat women with symptomatic vulvovaginal atrophy and GSM through similar mechanisms described in dermatologic conditions with low-temperature laser activation of tissue proteins and growth factors creating new connective tissue and angiogenesis. A number of landmark studies have been published detailing patient outcomes with energy-based treatments for these symptoms.

Three-arm trial. Cruz and colleagues conducted a double-blind randomized trial to evaluate the efficacy of fractional CO2 laser vaginal treatment compared with local estriol therapy and the combination of laser plus estriol.⁸ The investigators randomly assigned 45 postmenopausal women to treatment with fractional CO2 laser with placebo vaginal cream, estriol with sham laser, or laser plus estriol. Treatment consisted of 2 sessions 4 weeks apart, with 20 consecutive weeks of estriol or placebo 3 times per week.

At weeks 8 and 20, the Vaginal Health Index (VHI) average score was significantly higher in all study arms. At week 20, the laser plus estriol group also showed incremental improvement in the VHI score (P = .01). The laser and the laser plus estriol groups had significant improvement in dyspareunia, burning, and dryness, while the estriol group improved only in dryness (P<.001). The laser plus estriol group had significant improvement in the total Female Sexual Function Index (FSFI) score (P = .02) and in the individual domains of pain, desire, and lubrication. Although the laser-alone group had significant worsening in the FSFI pain domain (P = .04), all treatment arms had comparable FSFI total scores at week 20. No adverse events were recorded during the study period.

Continue to: Retrospective study...

Retrospective study. To assess the efficacy of 3, 4, or 5 treatments with microablative fractional CO2 laser therapy for symptoms of GSM, Athanasiou and colleagues studied outcomes in 94 postmenopausal women.⁹ The intensity or bothersomeness of GSM symptoms as well as sexual function significantly improved in this cohort. The intensity of dyspareunia and dryness decreased from a median of 9 (minimum–maximum, 5–10) and 8 (0–10), respectively, at baseline to 0 (0–6) and 0 (0–8) at 1 month after the last laser therapy (P<.001 for all). The FSFI score and the frequency of sexual intercourse rose from 10.8 (2–26.9) and 1 (0–8) at baseline to 27.8 (15.2–35.4) and 4 (2–8) at 1 month after the last laser therapy (P<.001 for all).

The positive effects of laser therapy were unchanged throughout the 12 months of follow-up, and the pattern was the same for symptom-free rates. No adverse events were recorded during the study period.

The investigators noted that, based on short- and long-term follow-up, 4 or 5 laser treatments may be superior to 3 treatments for lowering the intensity of GSM symptoms. They found no differences in outcomes between 4 and 5 laser treatments.

Prospective comparative cohort study. Gaspar and colleagues recruited 50 postmenopausal women with GSM and assigned 25 participants to 2 weeks of pretreatment with estriol ovules 3 times per week (for epithelial hydration) followed by 3 sessions of Er:YAG nonablative laser treatments; 25 women in the active control group received treatment with estriol ovules over 8 weeks.¹⁰ Pre- and posttreatment biopsies, maturation index, maturation value, pH, and VAS symptom analysis were recorded up to 18 months after treatment.

Up to the 6-month follow-up, both treatment groups had a statistically significant reduction of all GSM symptoms. At all follow-ups, however, symptom relief was more prominent in the laser-treated group. In addition, the effects of the laser therapy remained statistically significant at the 12- and 18-month follow-ups, while the treatment effects of estriol were diminished at 12 months and, at 18 months, this group had some symptoms that were significantly worse than before treatment.

Overall, adverse effects were minimal and transient in both groups, affecting 4% of participants in the laser group, and 12% in the estriol group.

Long-term effectiveness evaluation. To assess the long-term efficacy and acceptability of vaginal laser treatment for the management of GSM, Gambacciani and colleagues treated 205 postmenopausal women with an Er:YAG laser for 3 applications every 30 days, with evaluations performed after 1, 3, 6, 12, 18, and 24 months from the last laser treatment.¹¹ An active control group (n = 49) received 3 months of local treatment with either hormonal (estriol gel twice weekly) or nonhormonal (hyaluronic acid-based preparations or moisturizers and lubricants) agents.

Treatment with the ER:YAG laser induced a significant decrease (P<.01) in scores of the Visual Analog Scale (VAS) for vulvovaginal atrophy symptoms for vaginal dryness and dyspareunia and an increase in the VHI score (P<.01) up to 12 months after the last treatment. After 18 and 24 months, values returned to levels similar to those at baseline.

Women who also had stress UI (n = 114) received additional laser treatment of the anterior vaginal wall specifically designed for UI, with assessment based on the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Laser treatment induced a significant decrease (P<.05) in ICIQ-UI SF scores compared with baseline values, and scores remained lower than baseline values after 1, 2, 3, 6, and 12 months after the last laser treatment. Values measured after 18 and 24 months, however, did not differ significantly from baseline.

In the control group, the VAS score showed a similar decrease and comparable pattern during the treatment period. However, after the end of the treatment period, the control group’s VAS scores for vaginal dryness and dyspareunia showed a progressive increase, and after 6 months, the values were significantly different from corresponding values measured in the laser therapy group. The follow-up period in the control group ended after 6 months, because almost all patients started a new local or systemic treatment for their GSM symptoms. No adverse events related to treatment were recorded throughout the study period.

In an earlier pilot study by the same authors, 19 women with GSM who also had mild to moderate stress UI were treated with a vaginal Er:YAG laser.¹² Compared with vaginal estriol treatment in the active control group, laser treatment was associated with a significant improvement (P<.01) in ICIQ-SF scores, with rapid and long-lasting effects that persisted up to week 24 of the observation period.

Continue to: Urinary incontinence...

Urinary incontinence

The cause of UI is considered to be multifactorial, including disruption in connective tissue supports of the urethrovesical junction leading to urethral hypermobility, pelvic floor muscle weakness, nerve damage to the urethral rhabdosphincter related to pudendal neuropathy or pelvic plexopathy, and atrophic changes of the urethra mucosa and submucosa. Purported mechanisms of action for energy-based therapies designed for treatment of UI relate to direct effects on connective tissue, blood vessels, and possibly nerves.

In 3 clinical trials designed specifically to treat UI with an Er:YAG laser, women showed subjective symptomatic improvement.

Ogrinc and colleagues followed 175 pre- and postmenopausal women with stress UI or mixed UI in a prospective nonrandomized study.¹³ They treated women with an Er:YAG laser for an average of 2.5 (0.5) procedures separated by a 2-month period and performed follow-up assessments at 2, 6, and 12 months after treatment.

After treatment, 77% of women with stress UI had significant improvement in symptoms based on the ICIQ SF and the Incontinence Severity Index (ISI), while only 34% of those with mixed UI had no symptoms at 1-year follow-up. No major adverse effects were noted in either group.

Okui compared the effects of Er:YAG laser treatment with those of tension-free vaginal tape (TVT) or transobturator tape (TOT) sling procedures (n = 50 in each group) in women with stress UI or mixed UI.¹⁴ At 12 months after treatment, all 3 treatments demonstrated comparable improvements in the women with stress UI. Some patients with mixed UI in the TVT and TOT groups showed exacerbation, while all women in the laser-treated group tended to have symptom improvement.

In another recent study, Blaganje and colleagues randomly assigned 114 premenopausal parous women with stress UI to an Er:YAG laser procedure or sham treatment.¹⁵ Three months after treatment, ICIQ-UI SF scores were significantly more improved (P<.001) in the laser-treated group than in the sham group. In addition, 21% of laser-treated patients were dry at follow-up compared with 4% of the sham-treated group.

Key takeaway. While these studies showed promising short-term results for laser treatment of UI, they need to be replicated in appropriately powered clinical trials that include critical subjective and objective outcomes as well as longer-term follow-up for both effectiveness and safety.

Vaginal laxity/pre-prolapse

Vaginal laxity is defined as the symptom of excessive vaginal looseness.¹⁶ Also referred to as “pre-prolapse,” this subjective symptom generally refers to a widened vaginal opening (genital hiatus) but with pelvic organ prolapse that is within the vagina or hymen.¹⁷ Notably, the definition is ambiguous, and rigorous clinical data based on validated outcomes and prolapse grading are lacking.

Krychman and colleagues conducted the first randomized controlled study comparing monopolar radiofrequency at the vaginal introitus with sham therapy for vaginal laxity in 174 premenopausal women, known as the VIVEVE I trial.¹⁸ The primary outcome, the proportion of women reporting no vaginal laxity at 6 months after treatment, was assessed using a vaginal laxity questionnaire, a 7-point rating scale for laxity or tightness ranging from very loose to very tight. With a single radiofrequency treatment, 43.5% of the active group and 19.6% (P = .002) of the sham group obtained the primary outcome.

There were also statistically significant improvements in overall sexual function and decreased sexual distress. The adjusted odds ratio (OR, 3.39; 95% confidence interval, 1.54–7.45) showed that the likelihood of no vaginal laxity at 6 months was more than 3 times greater for women who received the active treatment compared with those who received sham treatment. Adverse events were mild, resolved spontaneously, and were similar in the 2 groups.

Continue to: Outlook for energy-based...

Outlook for energy-based therapies: Cautiously optimistic

Preliminary outcome data on the use of energy-based therapies for female genital cosmetic surgery is largely positive for the treatment of vulvovaginal atrophy, but some case series suggest the potential for scarring, burning, and inefficacy. This prompted the FDA to send “It has come to our attention” letters to a number of device manufacturers in 2018.⁶

Supportive evidence is weak. Early data are encouraging regarding fractionated laser therapy for the treatment of vulvovaginal atrophy and stress UI and radiofrequency wand therapy for vaginal laxity and stress UI. Unfortunately, the level of evidence to support wide use of these technologies for all pelvic floor disorders is weak. A recent committee opinion from the International Urogynecology Association noted that only 8 studies (1 randomized trial and 7 observational studies) on these conditions fulfilled the criteria of good quality.¹⁹ The International Continence Society and the International Society for the Study of Vulvovaginal Disorders recently published a best practice consensus document declaring laser and energy-based treatments in gynecology and urology to be largely experimental.²⁰

Questions persist. Knowledge gaps exist, and recommendations related to subspecialty training—who should perform these procedures (gynecologists, plastic surgeons, urologists, dermatologists, family practitioners) and the level of training needed to safely perform them—are lacking. Patient selection and physician knowledge and experience related to female genital anatomy, female sexual function and dysfunction, multidisciplinary treatment options for various pelvic support problems and UI, as well as psychologic screening for body dysmorphic disorders, need to be considered in terms of treating both the functional and aesthetic aspects related to cosmetic and reconstructive gynecologic surgery.

Special considerations. The use of energy-based therapies in special populations, such as survivors of breast cancer or other gynecologic cancers, as well as women undergoing chemotherapy, radiation therapy, and hormonal manipulation (particularly with antiestrogenic SERMs and aromatase inhibitors) has not been adequately evaluated. A discussion of the risks, benefits, alternatives, and limited long-term outcome data for energy-based therapies in cancer survivors, as for all patients, must be included for adequate informed consent prior to undertaking these treatments.

Guidelines for appropriate tissue priming, laser settings, and concomitant energy-based technology with local hormone treatment (also known as laser-augmented drug delivery) need to be developed. Comparative long-term studies are needed to determine the safety and effectiveness of these technologies.

Caution advised. Given the lack of long-term safety and effectiveness data on energy-based therapies for the vague indications of vaginal laxity, and even for the well-defined conditions of stress UI and vulvovaginal atrophy, clinicians should exercise caution before promoting treatment, which can be expensive and is not without potential complications, such as vaginal pain, adhesive agglutination, and persistent dryness and dyspareunia.²¹

Fortunately, many randomized trials on various energy-based devices for gynecologic indications (GSM, stress UI, vaginal laxity, lichen sclerosus) are underway, and results from these studies will help inform future clinical practice and guideline development. 

Energy-based therapy use in gynecology dates back to the early 1970s, when ablative carbon dioxide (C02) lasers were employed to treat cervical erosions.¹ Soon after, reports were published on laser treatment for diethylstilbestrol-associated vaginal adenosis, laser laparoscopy for adhesiolysis, laser hysteroscopy, and laser genital wart ablation.² Starting around 2011, the first articles were published on the use of fractional C02 laser treatment for vulvovaginal atrophy.^3,4 Use of laser and light-based therapies to treat “vaginal rejuvenation” is now increasing at an annual rate of 26%. In a few years, North America is expected to be the largest market for vaginal laser rejuvenation. In 2016, more than 500,000 feminine rejuvenation procedures were performed in the United States, and it is estimated that more than 27,000 energy-based devices will be in operation by 2021.⁵

Clearly, there is considerable public interest and intrigue in office-based female genital cosmetic procedures. In 2018, the US Food and Drug Administration contacted 7 manufacturers of energy-based devices to request revision and clarification for marketing of these devices, since these technologies are neither cleared nor approved for cosmetic vulvovaginal conditions.⁶ The companies responded within 30 days.

In this article, we appraise the existing literature regarding the mechanism of action of energy-based therapies used in gynecology and review outcomes of their use in female genital cosmetic surgery.

Laser technology devices and how they work

LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. Laser devices are composed of 1) an excitable medium (gas, liquid, solid) needed to emit light, 2) an energy source to excite the medium, 3) mirrors to bounce the light back and forth, and 4) a delivery and cooling system (FIGURE 1).

The electromagnetic spectrum is the range of all the wavelengths of light, including visible light, radio waves, infrared light, ultraviolet light, x-rays, and gamma rays (FIGURE 2). Most lasers used for the treatment of vulvovaginal disorders, typically C02 and erbium:yttrium aluminum garnet (Er:YAG) lasers, involve the infrared wavelengths.

The basic principle of laser treatment is to match the wavelength of the laser with the absorption spectrum of the desired target—a chromophore such as hemoglobin, melanin, or water (FIGURE 3). In essence, light is absorbed by the chromophore (which in vulvar and vaginal tissues is mostly water) and transformed into heat, leading to target destruction. In a fractionated (or fractional) laser beam, the laser is broken up into many smaller beams that treat only portions of the treatment area, with areas of intact epithelium in between the treated areas. At appropriately low thermal denaturation temperatures (45° to 50°C), tissue regeneration can occur through activation of heat shock proteins and tissue growth factors, creating neocollagenesis and neovascularization.

Continue to: In dermatology, fractionated lasers...

In dermatology, fractionated lasers have been used in the treatment of hair removal, vascular and pigmented lesions, scars, wound healing, tattoo removal, warts, and actinic keratoses. For these conditions, the targeted chromophores are water, hemoglobin, melanosomes, and tattoo ink. The laser pulses must be shorter than the target tissue thermal relaxation times in order to avoid excess heating and collateral tissue damage. Choosing appropriate settings is critical to achieve selective heating, or destruction, of the target tissue. These settings include appropriate wavelengths, pulse durations, and fluence, which is energy delivered per unit area (typically, joules per square centimeter).

For gynecologic conditions, the lasers used are most often CO2, Er:YAG, and hybrid (which include ablative and nonablative wavelengths) devices. In the epithelium of the vagina and vulva, these lasers generally have a very shallow depth of optical penetration, on the order of 10 to 200 µm.

Radiofrequency-based devices emit focused electromagnetic waves

Radiofrequency systems use a wand to deliver radiofrequency energy to create heat within the subepithelial layers of vulvar and vaginal tissues, while the surface remains cool. These devices can use monopolar or bipolar energy (current) to create a reverse thermal gradient designed to heat the deeper tissues transepithelially at a higher temperature while a coolant protects the surface epithelium. Some wand technologies require multiple treatments, while others require only a single treatment.

The TABLE lists currently available energy-based technologies.

Therapeutic uses for energy-based devices

Investigators have studied laser devices for treating various gynecologic conditions, including vulvovaginal atrophy, stress urinary incontinence (UI), vaginal laxity, lichen sclerosus, and vulvodynia.

Vulvovaginal atrophy

Genitourinary syndrome of menopause (GSM) includes symptoms of vulvovaginal irritation, burning, itching, discharge, dyspareunia, lower urinary tract symptoms such as frequency and urinary tract infections, and vaginal dryness or vulvovaginal atrophy.⁷ First-line treatment for vulvovaginal atrophy includes the use of nonhormonal lubricants for intercourse and vaginal moisturizers, which temporarily moisten the vaginal epithelium. Low-dose vaginal estrogen is a second-line therapy for symptomatic vulvovaginal atrophy; newer pharmacologic options include dehydroepiandrosterone (DHEA) suppositories (prasterone), solubilized estradiol capsules, and the selective estrogen receptor modulator (SERM) ospemifene.

Fractionated CO2, Erb:YAG, and hybrid lasers also have been used to treat women with symptomatic vulvovaginal atrophy and GSM through similar mechanisms described in dermatologic conditions with low-temperature laser activation of tissue proteins and growth factors creating new connective tissue and angiogenesis. A number of landmark studies have been published detailing patient outcomes with energy-based treatments for these symptoms.

Three-arm trial. Cruz and colleagues conducted a double-blind randomized trial to evaluate the efficacy of fractional CO2 laser vaginal treatment compared with local estriol therapy and the combination of laser plus estriol.⁸ The investigators randomly assigned 45 postmenopausal women to treatment with fractional CO2 laser with placebo vaginal cream, estriol with sham laser, or laser plus estriol. Treatment consisted of 2 sessions 4 weeks apart, with 20 consecutive weeks of estriol or placebo 3 times per week.

At weeks 8 and 20, the Vaginal Health Index (VHI) average score was significantly higher in all study arms. At week 20, the laser plus estriol group also showed incremental improvement in the VHI score (P = .01). The laser and the laser plus estriol groups had significant improvement in dyspareunia, burning, and dryness, while the estriol group improved only in dryness (P<.001). The laser plus estriol group had significant improvement in the total Female Sexual Function Index (FSFI) score (P = .02) and in the individual domains of pain, desire, and lubrication. Although the laser-alone group had significant worsening in the FSFI pain domain (P = .04), all treatment arms had comparable FSFI total scores at week 20. No adverse events were recorded during the study period.

Continue to: Retrospective study...

Retrospective study. To assess the efficacy of 3, 4, or 5 treatments with microablative fractional CO2 laser therapy for symptoms of GSM, Athanasiou and colleagues studied outcomes in 94 postmenopausal women.⁹ The intensity or bothersomeness of GSM symptoms as well as sexual function significantly improved in this cohort. The intensity of dyspareunia and dryness decreased from a median of 9 (minimum–maximum, 5–10) and 8 (0–10), respectively, at baseline to 0 (0–6) and 0 (0–8) at 1 month after the last laser therapy (P<.001 for all). The FSFI score and the frequency of sexual intercourse rose from 10.8 (2–26.9) and 1 (0–8) at baseline to 27.8 (15.2–35.4) and 4 (2–8) at 1 month after the last laser therapy (P<.001 for all).

The positive effects of laser therapy were unchanged throughout the 12 months of follow-up, and the pattern was the same for symptom-free rates. No adverse events were recorded during the study period.

The investigators noted that, based on short- and long-term follow-up, 4 or 5 laser treatments may be superior to 3 treatments for lowering the intensity of GSM symptoms. They found no differences in outcomes between 4 and 5 laser treatments.

Prospective comparative cohort study. Gaspar and colleagues recruited 50 postmenopausal women with GSM and assigned 25 participants to 2 weeks of pretreatment with estriol ovules 3 times per week (for epithelial hydration) followed by 3 sessions of Er:YAG nonablative laser treatments; 25 women in the active control group received treatment with estriol ovules over 8 weeks.¹⁰ Pre- and posttreatment biopsies, maturation index, maturation value, pH, and VAS symptom analysis were recorded up to 18 months after treatment.

Up to the 6-month follow-up, both treatment groups had a statistically significant reduction of all GSM symptoms. At all follow-ups, however, symptom relief was more prominent in the laser-treated group. In addition, the effects of the laser therapy remained statistically significant at the 12- and 18-month follow-ups, while the treatment effects of estriol were diminished at 12 months and, at 18 months, this group had some symptoms that were significantly worse than before treatment.

Overall, adverse effects were minimal and transient in both groups, affecting 4% of participants in the laser group, and 12% in the estriol group.

Long-term effectiveness evaluation. To assess the long-term efficacy and acceptability of vaginal laser treatment for the management of GSM, Gambacciani and colleagues treated 205 postmenopausal women with an Er:YAG laser for 3 applications every 30 days, with evaluations performed after 1, 3, 6, 12, 18, and 24 months from the last laser treatment.¹¹ An active control group (n = 49) received 3 months of local treatment with either hormonal (estriol gel twice weekly) or nonhormonal (hyaluronic acid-based preparations or moisturizers and lubricants) agents.

Treatment with the ER:YAG laser induced a significant decrease (P<.01) in scores of the Visual Analog Scale (VAS) for vulvovaginal atrophy symptoms for vaginal dryness and dyspareunia and an increase in the VHI score (P<.01) up to 12 months after the last treatment. After 18 and 24 months, values returned to levels similar to those at baseline.

Women who also had stress UI (n = 114) received additional laser treatment of the anterior vaginal wall specifically designed for UI, with assessment based on the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Laser treatment induced a significant decrease (P<.05) in ICIQ-UI SF scores compared with baseline values, and scores remained lower than baseline values after 1, 2, 3, 6, and 12 months after the last laser treatment. Values measured after 18 and 24 months, however, did not differ significantly from baseline.

In the control group, the VAS score showed a similar decrease and comparable pattern during the treatment period. However, after the end of the treatment period, the control group’s VAS scores for vaginal dryness and dyspareunia showed a progressive increase, and after 6 months, the values were significantly different from corresponding values measured in the laser therapy group. The follow-up period in the control group ended after 6 months, because almost all patients started a new local or systemic treatment for their GSM symptoms. No adverse events related to treatment were recorded throughout the study period.

In an earlier pilot study by the same authors, 19 women with GSM who also had mild to moderate stress UI were treated with a vaginal Er:YAG laser.¹² Compared with vaginal estriol treatment in the active control group, laser treatment was associated with a significant improvement (P<.01) in ICIQ-SF scores, with rapid and long-lasting effects that persisted up to week 24 of the observation period.

Continue to: Urinary incontinence...

Urinary incontinence

The cause of UI is considered to be multifactorial, including disruption in connective tissue supports of the urethrovesical junction leading to urethral hypermobility, pelvic floor muscle weakness, nerve damage to the urethral rhabdosphincter related to pudendal neuropathy or pelvic plexopathy, and atrophic changes of the urethra mucosa and submucosa. Purported mechanisms of action for energy-based therapies designed for treatment of UI relate to direct effects on connective tissue, blood vessels, and possibly nerves.

In 3 clinical trials designed specifically to treat UI with an Er:YAG laser, women showed subjective symptomatic improvement.

Ogrinc and colleagues followed 175 pre- and postmenopausal women with stress UI or mixed UI in a prospective nonrandomized study.¹³ They treated women with an Er:YAG laser for an average of 2.5 (0.5) procedures separated by a 2-month period and performed follow-up assessments at 2, 6, and 12 months after treatment.

After treatment, 77% of women with stress UI had significant improvement in symptoms based on the ICIQ SF and the Incontinence Severity Index (ISI), while only 34% of those with mixed UI had no symptoms at 1-year follow-up. No major adverse effects were noted in either group.

Okui compared the effects of Er:YAG laser treatment with those of tension-free vaginal tape (TVT) or transobturator tape (TOT) sling procedures (n = 50 in each group) in women with stress UI or mixed UI.¹⁴ At 12 months after treatment, all 3 treatments demonstrated comparable improvements in the women with stress UI. Some patients with mixed UI in the TVT and TOT groups showed exacerbation, while all women in the laser-treated group tended to have symptom improvement.

In another recent study, Blaganje and colleagues randomly assigned 114 premenopausal parous women with stress UI to an Er:YAG laser procedure or sham treatment.¹⁵ Three months after treatment, ICIQ-UI SF scores were significantly more improved (P<.001) in the laser-treated group than in the sham group. In addition, 21% of laser-treated patients were dry at follow-up compared with 4% of the sham-treated group.

Key takeaway. While these studies showed promising short-term results for laser treatment of UI, they need to be replicated in appropriately powered clinical trials that include critical subjective and objective outcomes as well as longer-term follow-up for both effectiveness and safety.

Vaginal laxity/pre-prolapse

Vaginal laxity is defined as the symptom of excessive vaginal looseness.¹⁶ Also referred to as “pre-prolapse,” this subjective symptom generally refers to a widened vaginal opening (genital hiatus) but with pelvic organ prolapse that is within the vagina or hymen.¹⁷ Notably, the definition is ambiguous, and rigorous clinical data based on validated outcomes and prolapse grading are lacking.

Krychman and colleagues conducted the first randomized controlled study comparing monopolar radiofrequency at the vaginal introitus with sham therapy for vaginal laxity in 174 premenopausal women, known as the VIVEVE I trial.¹⁸ The primary outcome, the proportion of women reporting no vaginal laxity at 6 months after treatment, was assessed using a vaginal laxity questionnaire, a 7-point rating scale for laxity or tightness ranging from very loose to very tight. With a single radiofrequency treatment, 43.5% of the active group and 19.6% (P = .002) of the sham group obtained the primary outcome.

There were also statistically significant improvements in overall sexual function and decreased sexual distress. The adjusted odds ratio (OR, 3.39; 95% confidence interval, 1.54–7.45) showed that the likelihood of no vaginal laxity at 6 months was more than 3 times greater for women who received the active treatment compared with those who received sham treatment. Adverse events were mild, resolved spontaneously, and were similar in the 2 groups.

Continue to: Outlook for energy-based...

Outlook for energy-based therapies: Cautiously optimistic

Preliminary outcome data on the use of energy-based therapies for female genital cosmetic surgery is largely positive for the treatment of vulvovaginal atrophy, but some case series suggest the potential for scarring, burning, and inefficacy. This prompted the FDA to send “It has come to our attention” letters to a number of device manufacturers in 2018.⁶

Supportive evidence is weak. Early data are encouraging regarding fractionated laser therapy for the treatment of vulvovaginal atrophy and stress UI and radiofrequency wand therapy for vaginal laxity and stress UI. Unfortunately, the level of evidence to support wide use of these technologies for all pelvic floor disorders is weak. A recent committee opinion from the International Urogynecology Association noted that only 8 studies (1 randomized trial and 7 observational studies) on these conditions fulfilled the criteria of good quality.¹⁹ The International Continence Society and the International Society for the Study of Vulvovaginal Disorders recently published a best practice consensus document declaring laser and energy-based treatments in gynecology and urology to be largely experimental.²⁰

Questions persist. Knowledge gaps exist, and recommendations related to subspecialty training—who should perform these procedures (gynecologists, plastic surgeons, urologists, dermatologists, family practitioners) and the level of training needed to safely perform them—are lacking. Patient selection and physician knowledge and experience related to female genital anatomy, female sexual function and dysfunction, multidisciplinary treatment options for various pelvic support problems and UI, as well as psychologic screening for body dysmorphic disorders, need to be considered in terms of treating both the functional and aesthetic aspects related to cosmetic and reconstructive gynecologic surgery.

Special considerations. The use of energy-based therapies in special populations, such as survivors of breast cancer or other gynecologic cancers, as well as women undergoing chemotherapy, radiation therapy, and hormonal manipulation (particularly with antiestrogenic SERMs and aromatase inhibitors) has not been adequately evaluated. A discussion of the risks, benefits, alternatives, and limited long-term outcome data for energy-based therapies in cancer survivors, as for all patients, must be included for adequate informed consent prior to undertaking these treatments.

Guidelines for appropriate tissue priming, laser settings, and concomitant energy-based technology with local hormone treatment (also known as laser-augmented drug delivery) need to be developed. Comparative long-term studies are needed to determine the safety and effectiveness of these technologies.

Caution advised. Given the lack of long-term safety and effectiveness data on energy-based therapies for the vague indications of vaginal laxity, and even for the well-defined conditions of stress UI and vulvovaginal atrophy, clinicians should exercise caution before promoting treatment, which can be expensive and is not without potential complications, such as vaginal pain, adhesive agglutination, and persistent dryness and dyspareunia.²¹

Fortunately, many randomized trials on various energy-based devices for gynecologic indications (GSM, stress UI, vaginal laxity, lichen sclerosus) are underway, and results from these studies will help inform future clinical practice and guideline development. 

Energy-based therapy use in gynecology dates back to the early 1970s, when ablative carbon dioxide (C02) lasers were employed to treat cervical erosions.¹ Soon after, reports were published on laser treatment for diethylstilbestrol-associated vaginal adenosis, laser laparoscopy for adhesiolysis, laser hysteroscopy, and laser genital wart ablation.² Starting around 2011, the first articles were published on the use of fractional C02 laser treatment for vulvovaginal atrophy.^3,4 Use of laser and light-based therapies to treat “vaginal rejuvenation” is now increasing at an annual rate of 26%. In a few years, North America is expected to be the largest market for vaginal laser rejuvenation. In 2016, more than 500,000 feminine rejuvenation procedures were performed in the United States, and it is estimated that more than 27,000 energy-based devices will be in operation by 2021.⁵

Clearly, there is considerable public interest and intrigue in office-based female genital cosmetic procedures. In 2018, the US Food and Drug Administration contacted 7 manufacturers of energy-based devices to request revision and clarification for marketing of these devices, since these technologies are neither cleared nor approved for cosmetic vulvovaginal conditions.⁶ The companies responded within 30 days.

In this article, we appraise the existing literature regarding the mechanism of action of energy-based therapies used in gynecology and review outcomes of their use in female genital cosmetic surgery.

Laser technology devices and how they work

LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. Laser devices are composed of 1) an excitable medium (gas, liquid, solid) needed to emit light, 2) an energy source to excite the medium, 3) mirrors to bounce the light back and forth, and 4) a delivery and cooling system (FIGURE 1).

The electromagnetic spectrum is the range of all the wavelengths of light, including visible light, radio waves, infrared light, ultraviolet light, x-rays, and gamma rays (FIGURE 2). Most lasers used for the treatment of vulvovaginal disorders, typically C02 and erbium:yttrium aluminum garnet (Er:YAG) lasers, involve the infrared wavelengths.

The basic principle of laser treatment is to match the wavelength of the laser with the absorption spectrum of the desired target—a chromophore such as hemoglobin, melanin, or water (FIGURE 3). In essence, light is absorbed by the chromophore (which in vulvar and vaginal tissues is mostly water) and transformed into heat, leading to target destruction. In a fractionated (or fractional) laser beam, the laser is broken up into many smaller beams that treat only portions of the treatment area, with areas of intact epithelium in between the treated areas. At appropriately low thermal denaturation temperatures (45° to 50°C), tissue regeneration can occur through activation of heat shock proteins and tissue growth factors, creating neocollagenesis and neovascularization.

Continue to: In dermatology, fractionated lasers...

In dermatology, fractionated lasers have been used in the treatment of hair removal, vascular and pigmented lesions, scars, wound healing, tattoo removal, warts, and actinic keratoses. For these conditions, the targeted chromophores are water, hemoglobin, melanosomes, and tattoo ink. The laser pulses must be shorter than the target tissue thermal relaxation times in order to avoid excess heating and collateral tissue damage. Choosing appropriate settings is critical to achieve selective heating, or destruction, of the target tissue. These settings include appropriate wavelengths, pulse durations, and fluence, which is energy delivered per unit area (typically, joules per square centimeter).

For gynecologic conditions, the lasers used are most often CO2, Er:YAG, and hybrid (which include ablative and nonablative wavelengths) devices. In the epithelium of the vagina and vulva, these lasers generally have a very shallow depth of optical penetration, on the order of 10 to 200 µm.

Radiofrequency-based devices emit focused electromagnetic waves

Radiofrequency systems use a wand to deliver radiofrequency energy to create heat within the subepithelial layers of vulvar and vaginal tissues, while the surface remains cool. These devices can use monopolar or bipolar energy (current) to create a reverse thermal gradient designed to heat the deeper tissues transepithelially at a higher temperature while a coolant protects the surface epithelium. Some wand technologies require multiple treatments, while others require only a single treatment.

The TABLE lists currently available energy-based technologies.

Therapeutic uses for energy-based devices

Investigators have studied laser devices for treating various gynecologic conditions, including vulvovaginal atrophy, stress urinary incontinence (UI), vaginal laxity, lichen sclerosus, and vulvodynia.

Vulvovaginal atrophy

Genitourinary syndrome of menopause (GSM) includes symptoms of vulvovaginal irritation, burning, itching, discharge, dyspareunia, lower urinary tract symptoms such as frequency and urinary tract infections, and vaginal dryness or vulvovaginal atrophy.⁷ First-line treatment for vulvovaginal atrophy includes the use of nonhormonal lubricants for intercourse and vaginal moisturizers, which temporarily moisten the vaginal epithelium. Low-dose vaginal estrogen is a second-line therapy for symptomatic vulvovaginal atrophy; newer pharmacologic options include dehydroepiandrosterone (DHEA) suppositories (prasterone), solubilized estradiol capsules, and the selective estrogen receptor modulator (SERM) ospemifene.

Fractionated CO2, Erb:YAG, and hybrid lasers also have been used to treat women with symptomatic vulvovaginal atrophy and GSM through similar mechanisms described in dermatologic conditions with low-temperature laser activation of tissue proteins and growth factors creating new connective tissue and angiogenesis. A number of landmark studies have been published detailing patient outcomes with energy-based treatments for these symptoms.

Three-arm trial. Cruz and colleagues conducted a double-blind randomized trial to evaluate the efficacy of fractional CO2 laser vaginal treatment compared with local estriol therapy and the combination of laser plus estriol.⁸ The investigators randomly assigned 45 postmenopausal women to treatment with fractional CO2 laser with placebo vaginal cream, estriol with sham laser, or laser plus estriol. Treatment consisted of 2 sessions 4 weeks apart, with 20 consecutive weeks of estriol or placebo 3 times per week.

At weeks 8 and 20, the Vaginal Health Index (VHI) average score was significantly higher in all study arms. At week 20, the laser plus estriol group also showed incremental improvement in the VHI score (P = .01). The laser and the laser plus estriol groups had significant improvement in dyspareunia, burning, and dryness, while the estriol group improved only in dryness (P<.001). The laser plus estriol group had significant improvement in the total Female Sexual Function Index (FSFI) score (P = .02) and in the individual domains of pain, desire, and lubrication. Although the laser-alone group had significant worsening in the FSFI pain domain (P = .04), all treatment arms had comparable FSFI total scores at week 20. No adverse events were recorded during the study period.

Continue to: Retrospective study...

Retrospective study. To assess the efficacy of 3, 4, or 5 treatments with microablative fractional CO2 laser therapy for symptoms of GSM, Athanasiou and colleagues studied outcomes in 94 postmenopausal women.⁹ The intensity or bothersomeness of GSM symptoms as well as sexual function significantly improved in this cohort. The intensity of dyspareunia and dryness decreased from a median of 9 (minimum–maximum, 5–10) and 8 (0–10), respectively, at baseline to 0 (0–6) and 0 (0–8) at 1 month after the last laser therapy (P<.001 for all). The FSFI score and the frequency of sexual intercourse rose from 10.8 (2–26.9) and 1 (0–8) at baseline to 27.8 (15.2–35.4) and 4 (2–8) at 1 month after the last laser therapy (P<.001 for all).

The positive effects of laser therapy were unchanged throughout the 12 months of follow-up, and the pattern was the same for symptom-free rates. No adverse events were recorded during the study period.

The investigators noted that, based on short- and long-term follow-up, 4 or 5 laser treatments may be superior to 3 treatments for lowering the intensity of GSM symptoms. They found no differences in outcomes between 4 and 5 laser treatments.

Prospective comparative cohort study. Gaspar and colleagues recruited 50 postmenopausal women with GSM and assigned 25 participants to 2 weeks of pretreatment with estriol ovules 3 times per week (for epithelial hydration) followed by 3 sessions of Er:YAG nonablative laser treatments; 25 women in the active control group received treatment with estriol ovules over 8 weeks.¹⁰ Pre- and posttreatment biopsies, maturation index, maturation value, pH, and VAS symptom analysis were recorded up to 18 months after treatment.

Up to the 6-month follow-up, both treatment groups had a statistically significant reduction of all GSM symptoms. At all follow-ups, however, symptom relief was more prominent in the laser-treated group. In addition, the effects of the laser therapy remained statistically significant at the 12- and 18-month follow-ups, while the treatment effects of estriol were diminished at 12 months and, at 18 months, this group had some symptoms that were significantly worse than before treatment.

Overall, adverse effects were minimal and transient in both groups, affecting 4% of participants in the laser group, and 12% in the estriol group.

Long-term effectiveness evaluation. To assess the long-term efficacy and acceptability of vaginal laser treatment for the management of GSM, Gambacciani and colleagues treated 205 postmenopausal women with an Er:YAG laser for 3 applications every 30 days, with evaluations performed after 1, 3, 6, 12, 18, and 24 months from the last laser treatment.¹¹ An active control group (n = 49) received 3 months of local treatment with either hormonal (estriol gel twice weekly) or nonhormonal (hyaluronic acid-based preparations or moisturizers and lubricants) agents.

Treatment with the ER:YAG laser induced a significant decrease (P<.01) in scores of the Visual Analog Scale (VAS) for vulvovaginal atrophy symptoms for vaginal dryness and dyspareunia and an increase in the VHI score (P<.01) up to 12 months after the last treatment. After 18 and 24 months, values returned to levels similar to those at baseline.

Women who also had stress UI (n = 114) received additional laser treatment of the anterior vaginal wall specifically designed for UI, with assessment based on the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Laser treatment induced a significant decrease (P<.05) in ICIQ-UI SF scores compared with baseline values, and scores remained lower than baseline values after 1, 2, 3, 6, and 12 months after the last laser treatment. Values measured after 18 and 24 months, however, did not differ significantly from baseline.

In the control group, the VAS score showed a similar decrease and comparable pattern during the treatment period. However, after the end of the treatment period, the control group’s VAS scores for vaginal dryness and dyspareunia showed a progressive increase, and after 6 months, the values were significantly different from corresponding values measured in the laser therapy group. The follow-up period in the control group ended after 6 months, because almost all patients started a new local or systemic treatment for their GSM symptoms. No adverse events related to treatment were recorded throughout the study period.

In an earlier pilot study by the same authors, 19 women with GSM who also had mild to moderate stress UI were treated with a vaginal Er:YAG laser.¹² Compared with vaginal estriol treatment in the active control group, laser treatment was associated with a significant improvement (P<.01) in ICIQ-SF scores, with rapid and long-lasting effects that persisted up to week 24 of the observation period.

Continue to: Urinary incontinence...

Urinary incontinence

The cause of UI is considered to be multifactorial, including disruption in connective tissue supports of the urethrovesical junction leading to urethral hypermobility, pelvic floor muscle weakness, nerve damage to the urethral rhabdosphincter related to pudendal neuropathy or pelvic plexopathy, and atrophic changes of the urethra mucosa and submucosa. Purported mechanisms of action for energy-based therapies designed for treatment of UI relate to direct effects on connective tissue, blood vessels, and possibly nerves.

In 3 clinical trials designed specifically to treat UI with an Er:YAG laser, women showed subjective symptomatic improvement.

Ogrinc and colleagues followed 175 pre- and postmenopausal women with stress UI or mixed UI in a prospective nonrandomized study.¹³ They treated women with an Er:YAG laser for an average of 2.5 (0.5) procedures separated by a 2-month period and performed follow-up assessments at 2, 6, and 12 months after treatment.

After treatment, 77% of women with stress UI had significant improvement in symptoms based on the ICIQ SF and the Incontinence Severity Index (ISI), while only 34% of those with mixed UI had no symptoms at 1-year follow-up. No major adverse effects were noted in either group.

Okui compared the effects of Er:YAG laser treatment with those of tension-free vaginal tape (TVT) or transobturator tape (TOT) sling procedures (n = 50 in each group) in women with stress UI or mixed UI.¹⁴ At 12 months after treatment, all 3 treatments demonstrated comparable improvements in the women with stress UI. Some patients with mixed UI in the TVT and TOT groups showed exacerbation, while all women in the laser-treated group tended to have symptom improvement.

In another recent study, Blaganje and colleagues randomly assigned 114 premenopausal parous women with stress UI to an Er:YAG laser procedure or sham treatment.¹⁵ Three months after treatment, ICIQ-UI SF scores were significantly more improved (P<.001) in the laser-treated group than in the sham group. In addition, 21% of laser-treated patients were dry at follow-up compared with 4% of the sham-treated group.

Key takeaway. While these studies showed promising short-term results for laser treatment of UI, they need to be replicated in appropriately powered clinical trials that include critical subjective and objective outcomes as well as longer-term follow-up for both effectiveness and safety.

Vaginal laxity/pre-prolapse

Vaginal laxity is defined as the symptom of excessive vaginal looseness.¹⁶ Also referred to as “pre-prolapse,” this subjective symptom generally refers to a widened vaginal opening (genital hiatus) but with pelvic organ prolapse that is within the vagina or hymen.¹⁷ Notably, the definition is ambiguous, and rigorous clinical data based on validated outcomes and prolapse grading are lacking.

Krychman and colleagues conducted the first randomized controlled study comparing monopolar radiofrequency at the vaginal introitus with sham therapy for vaginal laxity in 174 premenopausal women, known as the VIVEVE I trial.¹⁸ The primary outcome, the proportion of women reporting no vaginal laxity at 6 months after treatment, was assessed using a vaginal laxity questionnaire, a 7-point rating scale for laxity or tightness ranging from very loose to very tight. With a single radiofrequency treatment, 43.5% of the active group and 19.6% (P = .002) of the sham group obtained the primary outcome.

There were also statistically significant improvements in overall sexual function and decreased sexual distress. The adjusted odds ratio (OR, 3.39; 95% confidence interval, 1.54–7.45) showed that the likelihood of no vaginal laxity at 6 months was more than 3 times greater for women who received the active treatment compared with those who received sham treatment. Adverse events were mild, resolved spontaneously, and were similar in the 2 groups.

Continue to: Outlook for energy-based...

Outlook for energy-based therapies: Cautiously optimistic

Preliminary outcome data on the use of energy-based therapies for female genital cosmetic surgery is largely positive for the treatment of vulvovaginal atrophy, but some case series suggest the potential for scarring, burning, and inefficacy. This prompted the FDA to send “It has come to our attention” letters to a number of device manufacturers in 2018.⁶

Supportive evidence is weak. Early data are encouraging regarding fractionated laser therapy for the treatment of vulvovaginal atrophy and stress UI and radiofrequency wand therapy for vaginal laxity and stress UI. Unfortunately, the level of evidence to support wide use of these technologies for all pelvic floor disorders is weak. A recent committee opinion from the International Urogynecology Association noted that only 8 studies (1 randomized trial and 7 observational studies) on these conditions fulfilled the criteria of good quality.¹⁹ The International Continence Society and the International Society for the Study of Vulvovaginal Disorders recently published a best practice consensus document declaring laser and energy-based treatments in gynecology and urology to be largely experimental.²⁰

Questions persist. Knowledge gaps exist, and recommendations related to subspecialty training—who should perform these procedures (gynecologists, plastic surgeons, urologists, dermatologists, family practitioners) and the level of training needed to safely perform them—are lacking. Patient selection and physician knowledge and experience related to female genital anatomy, female sexual function and dysfunction, multidisciplinary treatment options for various pelvic support problems and UI, as well as psychologic screening for body dysmorphic disorders, need to be considered in terms of treating both the functional and aesthetic aspects related to cosmetic and reconstructive gynecologic surgery.

Special considerations. The use of energy-based therapies in special populations, such as survivors of breast cancer or other gynecologic cancers, as well as women undergoing chemotherapy, radiation therapy, and hormonal manipulation (particularly with antiestrogenic SERMs and aromatase inhibitors) has not been adequately evaluated. A discussion of the risks, benefits, alternatives, and limited long-term outcome data for energy-based therapies in cancer survivors, as for all patients, must be included for adequate informed consent prior to undertaking these treatments.

Guidelines for appropriate tissue priming, laser settings, and concomitant energy-based technology with local hormone treatment (also known as laser-augmented drug delivery) need to be developed. Comparative long-term studies are needed to determine the safety and effectiveness of these technologies.

Caution advised. Given the lack of long-term safety and effectiveness data on energy-based therapies for the vague indications of vaginal laxity, and even for the well-defined conditions of stress UI and vulvovaginal atrophy, clinicians should exercise caution before promoting treatment, which can be expensive and is not without potential complications, such as vaginal pain, adhesive agglutination, and persistent dryness and dyspareunia.²¹

Fortunately, many randomized trials on various energy-based devices for gynecologic indications (GSM, stress UI, vaginal laxity, lichen sclerosus) are underway, and results from these studies will help inform future clinical practice and guideline development. 

Sexual dysfunction is challenging for patients and clinicians. Just as sexual function is multidimensional—with physical and psychosocial elements—sexual dysfunction can likewise have multiple contributing factors, and is often divided into dysfunction of desire, arousal, orgasm, and sex-related pain. Addressing each of these dimensions of sexual dysfunction in relationship to pelvic reconstructive surgery is beyond the scope of this article. Here, we focus on aspects of sexual dysfunction most likely to be reported by patients after surgery for pelvic organ prolapse (POP) or urinary incontinence, or for both. We discuss what is known about why sexual dysfunction develops after these procedures; how to assess symptoms when sexual dysfunction occurs; and how best to treat these difficult problems.

CASE Postoperative sexual concerns

Your 62-year-old patient presents 2 weeks after vaginal hysterectomy, uterosacral vault suspension, anterior and posterior colporrhaphy, and retropubic midurethral polypropylene sling placement. She reports feeling tired but otherwise doing well.

The patient returns 8 weeks postoperatively, having just resumed her customary exercise routine, and reports that she is feeling well. Upon questioning, she says that she has not yet attempted to have sexual intercourse with her 70-year-old husband.

The patient returns 6 months later and reports that, although she is doing well overall, she is unable to have sexual intercourse.

How can you help this patient? What next steps in evaluation are indicated? Then, with an understanding of her problem in hand, what treatment options can you offer to her?

Surgery for pelvic-floor disorders and sexual function

The impact of surgery on sexual function is important to discuss with patients preoperatively and postoperatively. Because patients with POP and urinary incontinence have a higher rate of sexual dysfunction at baseline, it is important to know how surgery to correct these conditions can affect sexual function.¹ Regrettably, many studies of surgical procedures for POP and urinary incontinence either do not include sexual function outcomes or are not powered to detect differences in these outcomes.

Native-tissue repair. A 2015 systematic review looked at studies of women undergoing native-tissue repair for POP without mesh placement of any kind, including a midurethral sling.² Based on 9 studies that reported validated sexual function questionnaire scores, investigators determined that sexual function scores generally improved following surgery. Collectively, for studies included in this review that specifically reported the rate of dyspareunia before and after surgery, 47% of women reported improvement in dyspareunia; 39% reported no change; 18% reported deterioration in dyspareunia; and only 4% had de novo dyspareunia.

Colporrhaphy. Posterior colporrhaphy, commonly performed to correct posterior vaginal prolapse, can narrow vaginal caliber and the introitus, potentially causing dyspareunia. Early description of posterior colporrhaphy technique included plication of the levator ani muscles, which was associated with significant risk of dyspareunia postoperatively.³ However, posterior colporrhaphy that involves standard plication of the rectovaginal muscularis or site-specific repair has been reported to have a dyspareunia rate from 7% to 20%.^4,5 It is generally recommended, therefore, that levator muscle plication during colporrhaphy be avoided in sexually active women.

Continue to: Vaginal mesh...

Vaginal mesh. Mesh has been used in various surgical procedures to correct pelvic floor disorders. Numerous randomized trials have comparatively evaluated the use of transvaginal polypropylene mesh and native tissue for POP repair, and many of these studies have assessed postoperative sexual function. In a 2013 systematic review on sexual function after POP repair, the authors found no significant difference in postoperative sexual function scores or the dyspareunia rate after vaginal mesh repair (14%) and after native-tissue repair (12%).⁶

Studies of postsurgical sexual function are lacking

Important aspects of sexual function—orgasm, arousal, desire, lubrication, sexual satisfaction, effects on the partner—lack studies. A study of 71 sexually active couples assessed sexual function with questionnaires before and after vaginal native-tissue repair and found that, except for orgasm, all domains improved in female questionnaires. In male partners, interest, sexual drive, and overall satisfaction improved, whereas erection, ejaculation, and orgasm remained unchanged.⁷

Urinary incontinence during sexual intercourse affects approximately 30% of women with overactive bladder or stress incontinence.⁸ Several reviews have analyzed data on overall sexual function following urinary incontinence surgery:

• After stress incontinence surgery, the rate of coital incontinence was found to be significantly lower (odds ratio, 0.11).⁹ In this review, 18 studies, comprising more than 1,500 women, were analyzed, with most participants having undergone insertion of a midurethral mesh sling. Most women (55%) reported no change in overall sexual function, based on validated sexual questionnaire scores; 32% reported improvement; and 13% had deterioration in sexual function.
• As for type of midurethral sling, 2 reviews concluded that there is no difference in sexual function outcomes between retropubic and trans‑obturator sling routes.^9,10

Although most studies that have looked at POP and incontinence surgeries show either improvement or no change in sexual function, we stress that sexual function is a secondary outcome in most of those studies, which might not be appropriately powered to detect differences in outcomes. Furthermore, although studies describe dyspareunia and overall sexual function in validated questionnaire scores, most do not evaluate other specific domains of sexual function. It remains unclear, therefore, how POP and incontinence surgeries affect orgasm, desire, arousal, satisfaction, and partner sexual domains; more studies are needed to focus on these areas of female sexual function.

How do we assess these patients?

We do know that sexual function is important to women undergoing gynecologic surgery: In a recent qualitative study of women undergoing pelvic reconstruction, patients rated lack of improvement in sexual function following surgery a “very severe” adverse event.¹¹ Unfortunately, however, sexual activity and function is not always measured before gynecologic surgery. Although specific reporting guidelines do not exist for routine gynecologic surgery, a terminology report from the International Urogynecologic Association/International Continence Society (IUGA/ICS) recommends that sexual activity and partner status be evaluated prior to and following surgical treatment as essential outcomes.¹² In addition, the report recommends that sexual pain be assessed prior to and following surgical procedures.¹²

Ascertain sexual health. First, asking your patients simple questions about sexual function, pain, and bother before and after surgery opens the door to dialogue that allows them, and their partner, to express concerns to you in a safe environment. It also allows you to better understand the significant impact of your surgical interventions on their sexual health.

Questionnaires. Objective measures of vaginal blood flow and engorgement exist, but assessment of sexual activity in the clinical setting is largely limited to self-assessment with questionnaires. Incorporating simple questions, such as “Are you sexually active?,” “Do you have any problems with sexual activity?,” and “Do you have pain with activity?” are likely to be as effective as a more detailed interview and can identify women with sexual concerns.¹³ Many clinicians are put at a disadvantage, however, because they are faced with the difficult situation of addressing postoperative sexual problems without knowing whether the patient had such reports prior to surgery.

Continue to: Aside from simple screening tools...

Aside from simple screening tools, a number of sexual function questionnaires have been developed. Some are generic, and others are condition-specific:

• Generic questionnaires are typically designed to address the function of a range of women. For example, the Female Sexual Function Index comprises 19 questions. Domains include orgasm, desire, arousal, lubrication, pain and satisfaction.¹⁴
• Condition-specific questionnaires of sexual function each have been validated in their target population so that they measure nuances in sexual health relevant to that population. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire—IUGA-Revised includes questions about the domains listed for the generic Index (above) plus questions about the impact of coital incontinence or bulge symptoms on sexual function.¹²

History-taking. If a woman identifies a problem with sexual function, a thorough history helps elicit whether the condition is lifelong or acquired, situational or general, and, most important, whether or not it is bothersome to her.^14,15 It is important not to make assumptions when pursuing this part of the history, and to encourage patients to be candid about how they have sex and with whom.

Physical examination. The patient should undergo a complete physical exam, including 1) a detailed pelvic exam assessing the vulva, vagina, and pelvic-floor musculature, and 2) estrogenization of the tissue.

Partner concerns. For women who have a partner, addressing the concerns of that partner following gynecologic surgery can be useful to the couple: The partner might be concerned about inflicting pain or doing damage during sex after gynecologic surgery.

CASE Informative discussion

While ascertaining her sexual symptoms, your patient reveals to you that she has attempted sexual intercourse on 3 occasions; each time, penetration was too painful to continue. She tells you she did not have this problem before surgery.

The patient says that she has tried water-based lubricants and is using vaginal estrogen 3 times per week, but “nothing helps.” She reports that she is arousable and has been able to achieve orgasm with clitoral stimulation, but would like to have vaginal intercourse. Her husband does have erectile dysfunction, which, she tells you, can make penetration difficult.

On physical examination, you detect mild atrophy. Vaginal length is 9 cm; no narrowing or scarring of the vaginal introitus or canal is seen. No mesh is visible or palpable. The paths of the midurethral sling arms are nontender. However, levator muscles are tender and tense bilaterally.

Given these findings on examination, what steps can you take to relieve your patient’s pain?

What can we offer these patients?

Treating sexual dysfunction after pelvic reconstructive surgery must, as emphasized earlier, be guided by a careful history and physical exam. Doing so is critical to determining the underlying cause. Whenever feasible, offer the least invasive treatment.

The IUGA/ICS terminology report describes several symptoms of postoperative sexual dysfunction¹²:

• de novo sexual dysfunction
• de novo dyspareunia
• shortened vagina
• tight vagina (introital or vaginal narrowing, or both)
• scarred vagina (including mesh-related problems)
• hispareunia (pain experienced by a male partner after intercourse).

Of course, any one or combination of these symptoms can be present in a given patient. Furthermore, de novo sexual dysfunction, de novo dyspareunia, and hispareunia can have various underlying causes—again, underscoring the importance of the history and exam in determining treatment.

Continue to: Nonsurgical treatment...

Nonsurgical treatment

Nonhormonal vaginal lubricants and moisturizers; vaginal estrogen therapy. Although, in older women, vaginal atrophy is often not a new diagnosis postsurgically, the condition might have been untreated preoperatively and might therefore come into play in sexual dysfunction postoperatively. If a patient reports vaginal dryness or pain upon penetration, assess for vaginal atrophy and, if present, treat accordingly.

Vaginal dilation and physical therapy. A shortened, tight, or scarred vagina might be amenable to therapy with vaginal dilators and physical therapy, but might ultimately require surgery.

Pelvic-floor myalgia or spasm can develop after surgery or, as with atrophy, might have existed preoperatively but was left untreated. Pelvic-floor myalgia should be suspected if the patient describes difficult penetration or a feeling of tightness, even though scarring or constriction of the vagina is not seen on examination. Physical therapy with a specialist in pelvic floor treatment is a first-line treatment for pelvic-floor myalgia,¹⁶ and is likely to be a helpful adjunct in many situations, including mesh-related sexual problems.¹⁷

Oral or vaginal medications to relax pelvic-floor muscle spasm are an option, although efficacy data are limited. If pain is of longstanding duration and is thought to have a neuropathic component, successful use of tricyclic antidepressants, neuroleptics, and serotonin–norepinephrine reuptake inhibitors has been reported.¹⁸

Surgery

Data are sparse regarding surgical treatment of female sexual dysfunction after pelvic reconstructive surgery. Again, it is clear, however, that the key is carefully assessing each patient and then individualizing treatment. Patients can have any type of dysfunction that a patient who hasn’t had surgery can—but is also at risk of conditions directly related to surgery.

In any patient who has had mesh placed as part of surgery, thorough examination is necessary to determine whether or not the implant is involved in sexual dysfunction. If the dysfunction is an apparent result of surgery performed by another surgeon, make every effort to review the operative report to determine which material was implanted and how it was placed.

Trigger-point injection can be attempted in a patient who has site-specific tenderness that is not clearly associated with tissue obstruction of the vagina or mesh erosion.^12,19 Even in areas of apparent banding or scarring related to mesh, trigger-point injection can be attempted to alleviate pain. How often trigger-point injections should be performed is understudied.

If, on examination, tenderness that replicates the dyspareunia is elicited when palpating the levator or obturator internus muscle, pelvic-floor muscle trigger-point injection can be offered (although physical therapy is first-line treatment). Trigger-point injection also can be a useful adjunct in women who have another identified cause of pain but also have developed pelvic-floor muscle spasm.

Not addressing concomitant pelvic-floor myalgia could prevent successful treatment of pain. Inclusion of a pudendal block also might help to alleviate pain.

Continue to: Surgical resection...

Surgical resection. If a skin bridge is clearly observed at the introitus, or if the introitus has been overly narrowed by perineorrhaphy but the remainder of the vagina has adequate length and caliber, surgical resection of the skin bridge might relieve symptoms of difficult penetration. In the case of obstructive perineorrhaphy, an attempt at reversal can be made by incising the perineum vertically but then reapproximating the edges transversely—sometimes referred to as reverse perineorrhaphy.

If scar tissue found elsewhere in the vagina might obstruct penetration, this condition might also be amenable to resection. When scarring is annular, relaxing incisions can be made bilaterally to relieve tension on that tissue; alternatively, it might be necessary to perform a Z-plasty. Nearly always, severe scarring is accompanied by levator myalgia, and a combined approach of surgery and physical therapy is necessary.

Neovagina. It is possible to find vaginal stenosis or shortening, to a varying degree, after surgical prolapse repair, with or without mesh or graft. As discussed, vaginal dilation should be offered but, if this is ineffective, the patient might be a candidate for surgical creation of a neovagina. Numerous techniques have been described for patients with congenital vaginal agenesis, with a few reports of similar techniques used to treat iatrogenic vaginal stenosis or obliteration.

The general principle of all neovagina procedures is to create a space between bladder and rectum of adequate caliber and length for desired sexual function. Reported techniques include a thigh or buttock skin graft, use of bowel or peritoneum, and, recently, a buccal mucosa graft.^20,21

Resection or excision of mesh. In patients who develop sexual dysfunction after mesh placement, the problem can be caused by exposure of the mesh in the vagina or erosion into another organ, but can also arise in the absence of exposure or erosion. Patients might have tenderness to palpation at points where the mesh is palpable through the mucosa but not exposed.

Again, complete investigation is necessary to look for mesh involvement in the vagina and, depending on the type of implant, other adjacent organs. Assessing partner symptoms, such as pain and scratches, also can be telling.

If there is palpable tenderness on vaginal examination of the mesh, resection of the vaginal portion might be an option.¹⁷ Complete excision of mesh implants can be morbid, however, and might not provide a better outcome than partial excision. The risk of morbidity from complete mesh excision must be weighed against the likelihood that partial excision will not resolve pain and that the patient will require further excision subsequently.^17,22 Excising fragmented mesh can be difficult; making every attempt to understand the contribution of mesh to sexual dysfunction is therefore critical to determining how, and how much of, the mesh comes out at the first attempt.

Last, for any woman who opts for surgical intervention to treat pain, you should engage in a discussion to emphasize the multidimensional nature of sexual function and the fact that any surgical intervention might not completely resolve her dysfunction.

Continue to: CASE Discussing options...

CASE Discussing options, choosing an intervention

You discuss the examination findings (no shortening or narrowing of the vagina) with the patient. She is relieved but puzzled as to why she cannot have intercourse. You discuss the tension and tenderness of her pelvic floor and that this is likely the cause. You offer her physical therapy (PT). You also discuss muscle relaxing medications and trigger-point injections if physical therapy alone is unsuccessful or if she cannot do PT (as there are barriers, including insurance coverage and scheduling issues, to accessing PT for many patients). You encourage her to continue use of vaginal estrogen and lubricant during intercourse. She agrees to try PT.

At 3-month follow-up, she reports great improvement. She is able to have intercourse, although she says she still has discomfort sometimes. She continues to work with the pelvic floor physical therapist and feels optimistic. You plan to see her in 6 months but counsel her to call if symptoms are not improving or are worsening.

Sexual function must be part of the conversation

It is difficult to counsel patients about sexual function after pelvic reconstructive surgery because data that could guide identification of problems (and how to treat them) are incomplete. Assessingsexual function preoperatively and having an open conversation about risks and benefits of surgery, with specific mention of its impact on sexual health, are critical (see “Key touchpoints in managing sexual dysfunction after pelvic reconstructive surgery”).

It is also crucial to assess sexual function postoperatively as a matter of routine. Validated questionnaires can be a useful adjunct to a thorough history and physical exam, and can help guide your discussions.

Treatment of postop sexual dysfunction must, first, account for the complex nature of sexual function and, second, be individualized, starting with the least invasive options, when feasible. 

Sexual dysfunction is challenging for patients and clinicians. Just as sexual function is multidimensional—with physical and psychosocial elements—sexual dysfunction can likewise have multiple contributing factors, and is often divided into dysfunction of desire, arousal, orgasm, and sex-related pain. Addressing each of these dimensions of sexual dysfunction in relationship to pelvic reconstructive surgery is beyond the scope of this article. Here, we focus on aspects of sexual dysfunction most likely to be reported by patients after surgery for pelvic organ prolapse (POP) or urinary incontinence, or for both. We discuss what is known about why sexual dysfunction develops after these procedures; how to assess symptoms when sexual dysfunction occurs; and how best to treat these difficult problems.

CASE Postoperative sexual concerns

Your 62-year-old patient presents 2 weeks after vaginal hysterectomy, uterosacral vault suspension, anterior and posterior colporrhaphy, and retropubic midurethral polypropylene sling placement. She reports feeling tired but otherwise doing well.

The patient returns 8 weeks postoperatively, having just resumed her customary exercise routine, and reports that she is feeling well. Upon questioning, she says that she has not yet attempted to have sexual intercourse with her 70-year-old husband.

The patient returns 6 months later and reports that, although she is doing well overall, she is unable to have sexual intercourse.

How can you help this patient? What next steps in evaluation are indicated? Then, with an understanding of her problem in hand, what treatment options can you offer to her?

Surgery for pelvic-floor disorders and sexual function

The impact of surgery on sexual function is important to discuss with patients preoperatively and postoperatively. Because patients with POP and urinary incontinence have a higher rate of sexual dysfunction at baseline, it is important to know how surgery to correct these conditions can affect sexual function.¹ Regrettably, many studies of surgical procedures for POP and urinary incontinence either do not include sexual function outcomes or are not powered to detect differences in these outcomes.

Native-tissue repair. A 2015 systematic review looked at studies of women undergoing native-tissue repair for POP without mesh placement of any kind, including a midurethral sling.² Based on 9 studies that reported validated sexual function questionnaire scores, investigators determined that sexual function scores generally improved following surgery. Collectively, for studies included in this review that specifically reported the rate of dyspareunia before and after surgery, 47% of women reported improvement in dyspareunia; 39% reported no change; 18% reported deterioration in dyspareunia; and only 4% had de novo dyspareunia.

Colporrhaphy. Posterior colporrhaphy, commonly performed to correct posterior vaginal prolapse, can narrow vaginal caliber and the introitus, potentially causing dyspareunia. Early description of posterior colporrhaphy technique included plication of the levator ani muscles, which was associated with significant risk of dyspareunia postoperatively.³ However, posterior colporrhaphy that involves standard plication of the rectovaginal muscularis or site-specific repair has been reported to have a dyspareunia rate from 7% to 20%.^4,5 It is generally recommended, therefore, that levator muscle plication during colporrhaphy be avoided in sexually active women.

Continue to: Vaginal mesh...

Vaginal mesh. Mesh has been used in various surgical procedures to correct pelvic floor disorders. Numerous randomized trials have comparatively evaluated the use of transvaginal polypropylene mesh and native tissue for POP repair, and many of these studies have assessed postoperative sexual function. In a 2013 systematic review on sexual function after POP repair, the authors found no significant difference in postoperative sexual function scores or the dyspareunia rate after vaginal mesh repair (14%) and after native-tissue repair (12%).⁶

Studies of postsurgical sexual function are lacking

Important aspects of sexual function—orgasm, arousal, desire, lubrication, sexual satisfaction, effects on the partner—lack studies. A study of 71 sexually active couples assessed sexual function with questionnaires before and after vaginal native-tissue repair and found that, except for orgasm, all domains improved in female questionnaires. In male partners, interest, sexual drive, and overall satisfaction improved, whereas erection, ejaculation, and orgasm remained unchanged.⁷

Urinary incontinence during sexual intercourse affects approximately 30% of women with overactive bladder or stress incontinence.⁸ Several reviews have analyzed data on overall sexual function following urinary incontinence surgery:

• After stress incontinence surgery, the rate of coital incontinence was found to be significantly lower (odds ratio, 0.11).⁹ In this review, 18 studies, comprising more than 1,500 women, were analyzed, with most participants having undergone insertion of a midurethral mesh sling. Most women (55%) reported no change in overall sexual function, based on validated sexual questionnaire scores; 32% reported improvement; and 13% had deterioration in sexual function.
• As for type of midurethral sling, 2 reviews concluded that there is no difference in sexual function outcomes between retropubic and trans‑obturator sling routes.^9,10

Although most studies that have looked at POP and incontinence surgeries show either improvement or no change in sexual function, we stress that sexual function is a secondary outcome in most of those studies, which might not be appropriately powered to detect differences in outcomes. Furthermore, although studies describe dyspareunia and overall sexual function in validated questionnaire scores, most do not evaluate other specific domains of sexual function. It remains unclear, therefore, how POP and incontinence surgeries affect orgasm, desire, arousal, satisfaction, and partner sexual domains; more studies are needed to focus on these areas of female sexual function.

How do we assess these patients?

We do know that sexual function is important to women undergoing gynecologic surgery: In a recent qualitative study of women undergoing pelvic reconstruction, patients rated lack of improvement in sexual function following surgery a “very severe” adverse event.¹¹ Unfortunately, however, sexual activity and function is not always measured before gynecologic surgery. Although specific reporting guidelines do not exist for routine gynecologic surgery, a terminology report from the International Urogynecologic Association/International Continence Society (IUGA/ICS) recommends that sexual activity and partner status be evaluated prior to and following surgical treatment as essential outcomes.¹² In addition, the report recommends that sexual pain be assessed prior to and following surgical procedures.¹²

Ascertain sexual health. First, asking your patients simple questions about sexual function, pain, and bother before and after surgery opens the door to dialogue that allows them, and their partner, to express concerns to you in a safe environment. It also allows you to better understand the significant impact of your surgical interventions on their sexual health.

Questionnaires. Objective measures of vaginal blood flow and engorgement exist, but assessment of sexual activity in the clinical setting is largely limited to self-assessment with questionnaires. Incorporating simple questions, such as “Are you sexually active?,” “Do you have any problems with sexual activity?,” and “Do you have pain with activity?” are likely to be as effective as a more detailed interview and can identify women with sexual concerns.¹³ Many clinicians are put at a disadvantage, however, because they are faced with the difficult situation of addressing postoperative sexual problems without knowing whether the patient had such reports prior to surgery.

Continue to: Aside from simple screening tools...

Aside from simple screening tools, a number of sexual function questionnaires have been developed. Some are generic, and others are condition-specific:

• Generic questionnaires are typically designed to address the function of a range of women. For example, the Female Sexual Function Index comprises 19 questions. Domains include orgasm, desire, arousal, lubrication, pain and satisfaction.¹⁴
• Condition-specific questionnaires of sexual function each have been validated in their target population so that they measure nuances in sexual health relevant to that population. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire—IUGA-Revised includes questions about the domains listed for the generic Index (above) plus questions about the impact of coital incontinence or bulge symptoms on sexual function.¹²

History-taking. If a woman identifies a problem with sexual function, a thorough history helps elicit whether the condition is lifelong or acquired, situational or general, and, most important, whether or not it is bothersome to her.^14,15 It is important not to make assumptions when pursuing this part of the history, and to encourage patients to be candid about how they have sex and with whom.

Physical examination. The patient should undergo a complete physical exam, including 1) a detailed pelvic exam assessing the vulva, vagina, and pelvic-floor musculature, and 2) estrogenization of the tissue.

Partner concerns. For women who have a partner, addressing the concerns of that partner following gynecologic surgery can be useful to the couple: The partner might be concerned about inflicting pain or doing damage during sex after gynecologic surgery.

CASE Informative discussion

While ascertaining her sexual symptoms, your patient reveals to you that she has attempted sexual intercourse on 3 occasions; each time, penetration was too painful to continue. She tells you she did not have this problem before surgery.

The patient says that she has tried water-based lubricants and is using vaginal estrogen 3 times per week, but “nothing helps.” She reports that she is arousable and has been able to achieve orgasm with clitoral stimulation, but would like to have vaginal intercourse. Her husband does have erectile dysfunction, which, she tells you, can make penetration difficult.

On physical examination, you detect mild atrophy. Vaginal length is 9 cm; no narrowing or scarring of the vaginal introitus or canal is seen. No mesh is visible or palpable. The paths of the midurethral sling arms are nontender. However, levator muscles are tender and tense bilaterally.

Given these findings on examination, what steps can you take to relieve your patient’s pain?

What can we offer these patients?

Treating sexual dysfunction after pelvic reconstructive surgery must, as emphasized earlier, be guided by a careful history and physical exam. Doing so is critical to determining the underlying cause. Whenever feasible, offer the least invasive treatment.

The IUGA/ICS terminology report describes several symptoms of postoperative sexual dysfunction¹²:

• de novo sexual dysfunction
• de novo dyspareunia
• shortened vagina
• tight vagina (introital or vaginal narrowing, or both)
• scarred vagina (including mesh-related problems)
• hispareunia (pain experienced by a male partner after intercourse).

Of course, any one or combination of these symptoms can be present in a given patient. Furthermore, de novo sexual dysfunction, de novo dyspareunia, and hispareunia can have various underlying causes—again, underscoring the importance of the history and exam in determining treatment.

Continue to: Nonsurgical treatment...

Nonsurgical treatment

Nonhormonal vaginal lubricants and moisturizers; vaginal estrogen therapy. Although, in older women, vaginal atrophy is often not a new diagnosis postsurgically, the condition might have been untreated preoperatively and might therefore come into play in sexual dysfunction postoperatively. If a patient reports vaginal dryness or pain upon penetration, assess for vaginal atrophy and, if present, treat accordingly.

Vaginal dilation and physical therapy. A shortened, tight, or scarred vagina might be amenable to therapy with vaginal dilators and physical therapy, but might ultimately require surgery.

Pelvic-floor myalgia or spasm can develop after surgery or, as with atrophy, might have existed preoperatively but was left untreated. Pelvic-floor myalgia should be suspected if the patient describes difficult penetration or a feeling of tightness, even though scarring or constriction of the vagina is not seen on examination. Physical therapy with a specialist in pelvic floor treatment is a first-line treatment for pelvic-floor myalgia,¹⁶ and is likely to be a helpful adjunct in many situations, including mesh-related sexual problems.¹⁷

Oral or vaginal medications to relax pelvic-floor muscle spasm are an option, although efficacy data are limited. If pain is of longstanding duration and is thought to have a neuropathic component, successful use of tricyclic antidepressants, neuroleptics, and serotonin–norepinephrine reuptake inhibitors has been reported.¹⁸

Surgery

Data are sparse regarding surgical treatment of female sexual dysfunction after pelvic reconstructive surgery. Again, it is clear, however, that the key is carefully assessing each patient and then individualizing treatment. Patients can have any type of dysfunction that a patient who hasn’t had surgery can—but is also at risk of conditions directly related to surgery.

In any patient who has had mesh placed as part of surgery, thorough examination is necessary to determine whether or not the implant is involved in sexual dysfunction. If the dysfunction is an apparent result of surgery performed by another surgeon, make every effort to review the operative report to determine which material was implanted and how it was placed.

Trigger-point injection can be attempted in a patient who has site-specific tenderness that is not clearly associated with tissue obstruction of the vagina or mesh erosion.^12,19 Even in areas of apparent banding or scarring related to mesh, trigger-point injection can be attempted to alleviate pain. How often trigger-point injections should be performed is understudied.

If, on examination, tenderness that replicates the dyspareunia is elicited when palpating the levator or obturator internus muscle, pelvic-floor muscle trigger-point injection can be offered (although physical therapy is first-line treatment). Trigger-point injection also can be a useful adjunct in women who have another identified cause of pain but also have developed pelvic-floor muscle spasm.

Not addressing concomitant pelvic-floor myalgia could prevent successful treatment of pain. Inclusion of a pudendal block also might help to alleviate pain.

Continue to: Surgical resection...

Surgical resection. If a skin bridge is clearly observed at the introitus, or if the introitus has been overly narrowed by perineorrhaphy but the remainder of the vagina has adequate length and caliber, surgical resection of the skin bridge might relieve symptoms of difficult penetration. In the case of obstructive perineorrhaphy, an attempt at reversal can be made by incising the perineum vertically but then reapproximating the edges transversely—sometimes referred to as reverse perineorrhaphy.

If scar tissue found elsewhere in the vagina might obstruct penetration, this condition might also be amenable to resection. When scarring is annular, relaxing incisions can be made bilaterally to relieve tension on that tissue; alternatively, it might be necessary to perform a Z-plasty. Nearly always, severe scarring is accompanied by levator myalgia, and a combined approach of surgery and physical therapy is necessary.

Neovagina. It is possible to find vaginal stenosis or shortening, to a varying degree, after surgical prolapse repair, with or without mesh or graft. As discussed, vaginal dilation should be offered but, if this is ineffective, the patient might be a candidate for surgical creation of a neovagina. Numerous techniques have been described for patients with congenital vaginal agenesis, with a few reports of similar techniques used to treat iatrogenic vaginal stenosis or obliteration.

The general principle of all neovagina procedures is to create a space between bladder and rectum of adequate caliber and length for desired sexual function. Reported techniques include a thigh or buttock skin graft, use of bowel or peritoneum, and, recently, a buccal mucosa graft.^20,21

Resection or excision of mesh. In patients who develop sexual dysfunction after mesh placement, the problem can be caused by exposure of the mesh in the vagina or erosion into another organ, but can also arise in the absence of exposure or erosion. Patients might have tenderness to palpation at points where the mesh is palpable through the mucosa but not exposed.

Again, complete investigation is necessary to look for mesh involvement in the vagina and, depending on the type of implant, other adjacent organs. Assessing partner symptoms, such as pain and scratches, also can be telling.

If there is palpable tenderness on vaginal examination of the mesh, resection of the vaginal portion might be an option.¹⁷ Complete excision of mesh implants can be morbid, however, and might not provide a better outcome than partial excision. The risk of morbidity from complete mesh excision must be weighed against the likelihood that partial excision will not resolve pain and that the patient will require further excision subsequently.^17,22 Excising fragmented mesh can be difficult; making every attempt to understand the contribution of mesh to sexual dysfunction is therefore critical to determining how, and how much of, the mesh comes out at the first attempt.

Last, for any woman who opts for surgical intervention to treat pain, you should engage in a discussion to emphasize the multidimensional nature of sexual function and the fact that any surgical intervention might not completely resolve her dysfunction.

Continue to: CASE Discussing options...

CASE Discussing options, choosing an intervention

You discuss the examination findings (no shortening or narrowing of the vagina) with the patient. She is relieved but puzzled as to why she cannot have intercourse. You discuss the tension and tenderness of her pelvic floor and that this is likely the cause. You offer her physical therapy (PT). You also discuss muscle relaxing medications and trigger-point injections if physical therapy alone is unsuccessful or if she cannot do PT (as there are barriers, including insurance coverage and scheduling issues, to accessing PT for many patients). You encourage her to continue use of vaginal estrogen and lubricant during intercourse. She agrees to try PT.

At 3-month follow-up, she reports great improvement. She is able to have intercourse, although she says she still has discomfort sometimes. She continues to work with the pelvic floor physical therapist and feels optimistic. You plan to see her in 6 months but counsel her to call if symptoms are not improving or are worsening.

Sexual function must be part of the conversation

It is difficult to counsel patients about sexual function after pelvic reconstructive surgery because data that could guide identification of problems (and how to treat them) are incomplete. Assessingsexual function preoperatively and having an open conversation about risks and benefits of surgery, with specific mention of its impact on sexual health, are critical (see “Key touchpoints in managing sexual dysfunction after pelvic reconstructive surgery”).

It is also crucial to assess sexual function postoperatively as a matter of routine. Validated questionnaires can be a useful adjunct to a thorough history and physical exam, and can help guide your discussions.

Treatment of postop sexual dysfunction must, first, account for the complex nature of sexual function and, second, be individualized, starting with the least invasive options, when feasible. 

Sexual dysfunction is challenging for patients and clinicians. Just as sexual function is multidimensional—with physical and psychosocial elements—sexual dysfunction can likewise have multiple contributing factors, and is often divided into dysfunction of desire, arousal, orgasm, and sex-related pain. Addressing each of these dimensions of sexual dysfunction in relationship to pelvic reconstructive surgery is beyond the scope of this article. Here, we focus on aspects of sexual dysfunction most likely to be reported by patients after surgery for pelvic organ prolapse (POP) or urinary incontinence, or for both. We discuss what is known about why sexual dysfunction develops after these procedures; how to assess symptoms when sexual dysfunction occurs; and how best to treat these difficult problems.

CASE Postoperative sexual concerns

Your 62-year-old patient presents 2 weeks after vaginal hysterectomy, uterosacral vault suspension, anterior and posterior colporrhaphy, and retropubic midurethral polypropylene sling placement. She reports feeling tired but otherwise doing well.

The patient returns 8 weeks postoperatively, having just resumed her customary exercise routine, and reports that she is feeling well. Upon questioning, she says that she has not yet attempted to have sexual intercourse with her 70-year-old husband.

The patient returns 6 months later and reports that, although she is doing well overall, she is unable to have sexual intercourse.

How can you help this patient? What next steps in evaluation are indicated? Then, with an understanding of her problem in hand, what treatment options can you offer to her?

Surgery for pelvic-floor disorders and sexual function

The impact of surgery on sexual function is important to discuss with patients preoperatively and postoperatively. Because patients with POP and urinary incontinence have a higher rate of sexual dysfunction at baseline, it is important to know how surgery to correct these conditions can affect sexual function.¹ Regrettably, many studies of surgical procedures for POP and urinary incontinence either do not include sexual function outcomes or are not powered to detect differences in these outcomes.

Native-tissue repair. A 2015 systematic review looked at studies of women undergoing native-tissue repair for POP without mesh placement of any kind, including a midurethral sling.² Based on 9 studies that reported validated sexual function questionnaire scores, investigators determined that sexual function scores generally improved following surgery. Collectively, for studies included in this review that specifically reported the rate of dyspareunia before and after surgery, 47% of women reported improvement in dyspareunia; 39% reported no change; 18% reported deterioration in dyspareunia; and only 4% had de novo dyspareunia.

Colporrhaphy. Posterior colporrhaphy, commonly performed to correct posterior vaginal prolapse, can narrow vaginal caliber and the introitus, potentially causing dyspareunia. Early description of posterior colporrhaphy technique included plication of the levator ani muscles, which was associated with significant risk of dyspareunia postoperatively.³ However, posterior colporrhaphy that involves standard plication of the rectovaginal muscularis or site-specific repair has been reported to have a dyspareunia rate from 7% to 20%.^4,5 It is generally recommended, therefore, that levator muscle plication during colporrhaphy be avoided in sexually active women.

Continue to: Vaginal mesh...

Vaginal mesh. Mesh has been used in various surgical procedures to correct pelvic floor disorders. Numerous randomized trials have comparatively evaluated the use of transvaginal polypropylene mesh and native tissue for POP repair, and many of these studies have assessed postoperative sexual function. In a 2013 systematic review on sexual function after POP repair, the authors found no significant difference in postoperative sexual function scores or the dyspareunia rate after vaginal mesh repair (14%) and after native-tissue repair (12%).⁶

Studies of postsurgical sexual function are lacking

Important aspects of sexual function—orgasm, arousal, desire, lubrication, sexual satisfaction, effects on the partner—lack studies. A study of 71 sexually active couples assessed sexual function with questionnaires before and after vaginal native-tissue repair and found that, except for orgasm, all domains improved in female questionnaires. In male partners, interest, sexual drive, and overall satisfaction improved, whereas erection, ejaculation, and orgasm remained unchanged.⁷

Urinary incontinence during sexual intercourse affects approximately 30% of women with overactive bladder or stress incontinence.⁸ Several reviews have analyzed data on overall sexual function following urinary incontinence surgery:

• After stress incontinence surgery, the rate of coital incontinence was found to be significantly lower (odds ratio, 0.11).⁹ In this review, 18 studies, comprising more than 1,500 women, were analyzed, with most participants having undergone insertion of a midurethral mesh sling. Most women (55%) reported no change in overall sexual function, based on validated sexual questionnaire scores; 32% reported improvement; and 13% had deterioration in sexual function.
• As for type of midurethral sling, 2 reviews concluded that there is no difference in sexual function outcomes between retropubic and trans‑obturator sling routes.^9,10

Although most studies that have looked at POP and incontinence surgeries show either improvement or no change in sexual function, we stress that sexual function is a secondary outcome in most of those studies, which might not be appropriately powered to detect differences in outcomes. Furthermore, although studies describe dyspareunia and overall sexual function in validated questionnaire scores, most do not evaluate other specific domains of sexual function. It remains unclear, therefore, how POP and incontinence surgeries affect orgasm, desire, arousal, satisfaction, and partner sexual domains; more studies are needed to focus on these areas of female sexual function.

How do we assess these patients?

We do know that sexual function is important to women undergoing gynecologic surgery: In a recent qualitative study of women undergoing pelvic reconstruction, patients rated lack of improvement in sexual function following surgery a “very severe” adverse event.¹¹ Unfortunately, however, sexual activity and function is not always measured before gynecologic surgery. Although specific reporting guidelines do not exist for routine gynecologic surgery, a terminology report from the International Urogynecologic Association/International Continence Society (IUGA/ICS) recommends that sexual activity and partner status be evaluated prior to and following surgical treatment as essential outcomes.¹² In addition, the report recommends that sexual pain be assessed prior to and following surgical procedures.¹²

Ascertain sexual health. First, asking your patients simple questions about sexual function, pain, and bother before and after surgery opens the door to dialogue that allows them, and their partner, to express concerns to you in a safe environment. It also allows you to better understand the significant impact of your surgical interventions on their sexual health.

Questionnaires. Objective measures of vaginal blood flow and engorgement exist, but assessment of sexual activity in the clinical setting is largely limited to self-assessment with questionnaires. Incorporating simple questions, such as “Are you sexually active?,” “Do you have any problems with sexual activity?,” and “Do you have pain with activity?” are likely to be as effective as a more detailed interview and can identify women with sexual concerns.¹³ Many clinicians are put at a disadvantage, however, because they are faced with the difficult situation of addressing postoperative sexual problems without knowing whether the patient had such reports prior to surgery.

Continue to: Aside from simple screening tools...

Aside from simple screening tools, a number of sexual function questionnaires have been developed. Some are generic, and others are condition-specific:

• Generic questionnaires are typically designed to address the function of a range of women. For example, the Female Sexual Function Index comprises 19 questions. Domains include orgasm, desire, arousal, lubrication, pain and satisfaction.¹⁴
• Condition-specific questionnaires of sexual function each have been validated in their target population so that they measure nuances in sexual health relevant to that population. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire—IUGA-Revised includes questions about the domains listed for the generic Index (above) plus questions about the impact of coital incontinence or bulge symptoms on sexual function.¹²

History-taking. If a woman identifies a problem with sexual function, a thorough history helps elicit whether the condition is lifelong or acquired, situational or general, and, most important, whether or not it is bothersome to her.^14,15 It is important not to make assumptions when pursuing this part of the history, and to encourage patients to be candid about how they have sex and with whom.

Physical examination. The patient should undergo a complete physical exam, including 1) a detailed pelvic exam assessing the vulva, vagina, and pelvic-floor musculature, and 2) estrogenization of the tissue.

Partner concerns. For women who have a partner, addressing the concerns of that partner following gynecologic surgery can be useful to the couple: The partner might be concerned about inflicting pain or doing damage during sex after gynecologic surgery.

CASE Informative discussion

While ascertaining her sexual symptoms, your patient reveals to you that she has attempted sexual intercourse on 3 occasions; each time, penetration was too painful to continue. She tells you she did not have this problem before surgery.

The patient says that she has tried water-based lubricants and is using vaginal estrogen 3 times per week, but “nothing helps.” She reports that she is arousable and has been able to achieve orgasm with clitoral stimulation, but would like to have vaginal intercourse. Her husband does have erectile dysfunction, which, she tells you, can make penetration difficult.

On physical examination, you detect mild atrophy. Vaginal length is 9 cm; no narrowing or scarring of the vaginal introitus or canal is seen. No mesh is visible or palpable. The paths of the midurethral sling arms are nontender. However, levator muscles are tender and tense bilaterally.

Given these findings on examination, what steps can you take to relieve your patient’s pain?

What can we offer these patients?

Treating sexual dysfunction after pelvic reconstructive surgery must, as emphasized earlier, be guided by a careful history and physical exam. Doing so is critical to determining the underlying cause. Whenever feasible, offer the least invasive treatment.

The IUGA/ICS terminology report describes several symptoms of postoperative sexual dysfunction¹²:

• de novo sexual dysfunction
• de novo dyspareunia
• shortened vagina
• tight vagina (introital or vaginal narrowing, or both)
• scarred vagina (including mesh-related problems)
• hispareunia (pain experienced by a male partner after intercourse).

Of course, any one or combination of these symptoms can be present in a given patient. Furthermore, de novo sexual dysfunction, de novo dyspareunia, and hispareunia can have various underlying causes—again, underscoring the importance of the history and exam in determining treatment.

Continue to: Nonsurgical treatment...

Nonsurgical treatment

Nonhormonal vaginal lubricants and moisturizers; vaginal estrogen therapy. Although, in older women, vaginal atrophy is often not a new diagnosis postsurgically, the condition might have been untreated preoperatively and might therefore come into play in sexual dysfunction postoperatively. If a patient reports vaginal dryness or pain upon penetration, assess for vaginal atrophy and, if present, treat accordingly.

Vaginal dilation and physical therapy. A shortened, tight, or scarred vagina might be amenable to therapy with vaginal dilators and physical therapy, but might ultimately require surgery.

Pelvic-floor myalgia or spasm can develop after surgery or, as with atrophy, might have existed preoperatively but was left untreated. Pelvic-floor myalgia should be suspected if the patient describes difficult penetration or a feeling of tightness, even though scarring or constriction of the vagina is not seen on examination. Physical therapy with a specialist in pelvic floor treatment is a first-line treatment for pelvic-floor myalgia,¹⁶ and is likely to be a helpful adjunct in many situations, including mesh-related sexual problems.¹⁷

Oral or vaginal medications to relax pelvic-floor muscle spasm are an option, although efficacy data are limited. If pain is of longstanding duration and is thought to have a neuropathic component, successful use of tricyclic antidepressants, neuroleptics, and serotonin–norepinephrine reuptake inhibitors has been reported.¹⁸

Surgery

Data are sparse regarding surgical treatment of female sexual dysfunction after pelvic reconstructive surgery. Again, it is clear, however, that the key is carefully assessing each patient and then individualizing treatment. Patients can have any type of dysfunction that a patient who hasn’t had surgery can—but is also at risk of conditions directly related to surgery.

In any patient who has had mesh placed as part of surgery, thorough examination is necessary to determine whether or not the implant is involved in sexual dysfunction. If the dysfunction is an apparent result of surgery performed by another surgeon, make every effort to review the operative report to determine which material was implanted and how it was placed.

Trigger-point injection can be attempted in a patient who has site-specific tenderness that is not clearly associated with tissue obstruction of the vagina or mesh erosion.^12,19 Even in areas of apparent banding or scarring related to mesh, trigger-point injection can be attempted to alleviate pain. How often trigger-point injections should be performed is understudied.

If, on examination, tenderness that replicates the dyspareunia is elicited when palpating the levator or obturator internus muscle, pelvic-floor muscle trigger-point injection can be offered (although physical therapy is first-line treatment). Trigger-point injection also can be a useful adjunct in women who have another identified cause of pain but also have developed pelvic-floor muscle spasm.

Not addressing concomitant pelvic-floor myalgia could prevent successful treatment of pain. Inclusion of a pudendal block also might help to alleviate pain.

Continue to: Surgical resection...

Surgical resection. If a skin bridge is clearly observed at the introitus, or if the introitus has been overly narrowed by perineorrhaphy but the remainder of the vagina has adequate length and caliber, surgical resection of the skin bridge might relieve symptoms of difficult penetration. In the case of obstructive perineorrhaphy, an attempt at reversal can be made by incising the perineum vertically but then reapproximating the edges transversely—sometimes referred to as reverse perineorrhaphy.

If scar tissue found elsewhere in the vagina might obstruct penetration, this condition might also be amenable to resection. When scarring is annular, relaxing incisions can be made bilaterally to relieve tension on that tissue; alternatively, it might be necessary to perform a Z-plasty. Nearly always, severe scarring is accompanied by levator myalgia, and a combined approach of surgery and physical therapy is necessary.

Neovagina. It is possible to find vaginal stenosis or shortening, to a varying degree, after surgical prolapse repair, with or without mesh or graft. As discussed, vaginal dilation should be offered but, if this is ineffective, the patient might be a candidate for surgical creation of a neovagina. Numerous techniques have been described for patients with congenital vaginal agenesis, with a few reports of similar techniques used to treat iatrogenic vaginal stenosis or obliteration.

The general principle of all neovagina procedures is to create a space between bladder and rectum of adequate caliber and length for desired sexual function. Reported techniques include a thigh or buttock skin graft, use of bowel or peritoneum, and, recently, a buccal mucosa graft.^20,21

Resection or excision of mesh. In patients who develop sexual dysfunction after mesh placement, the problem can be caused by exposure of the mesh in the vagina or erosion into another organ, but can also arise in the absence of exposure or erosion. Patients might have tenderness to palpation at points where the mesh is palpable through the mucosa but not exposed.

Again, complete investigation is necessary to look for mesh involvement in the vagina and, depending on the type of implant, other adjacent organs. Assessing partner symptoms, such as pain and scratches, also can be telling.

If there is palpable tenderness on vaginal examination of the mesh, resection of the vaginal portion might be an option.¹⁷ Complete excision of mesh implants can be morbid, however, and might not provide a better outcome than partial excision. The risk of morbidity from complete mesh excision must be weighed against the likelihood that partial excision will not resolve pain and that the patient will require further excision subsequently.^17,22 Excising fragmented mesh can be difficult; making every attempt to understand the contribution of mesh to sexual dysfunction is therefore critical to determining how, and how much of, the mesh comes out at the first attempt.

Last, for any woman who opts for surgical intervention to treat pain, you should engage in a discussion to emphasize the multidimensional nature of sexual function and the fact that any surgical intervention might not completely resolve her dysfunction.

Continue to: CASE Discussing options...

CASE Discussing options, choosing an intervention

You discuss the examination findings (no shortening or narrowing of the vagina) with the patient. She is relieved but puzzled as to why she cannot have intercourse. You discuss the tension and tenderness of her pelvic floor and that this is likely the cause. You offer her physical therapy (PT). You also discuss muscle relaxing medications and trigger-point injections if physical therapy alone is unsuccessful or if she cannot do PT (as there are barriers, including insurance coverage and scheduling issues, to accessing PT for many patients). You encourage her to continue use of vaginal estrogen and lubricant during intercourse. She agrees to try PT.

At 3-month follow-up, she reports great improvement. She is able to have intercourse, although she says she still has discomfort sometimes. She continues to work with the pelvic floor physical therapist and feels optimistic. You plan to see her in 6 months but counsel her to call if symptoms are not improving or are worsening.

Sexual function must be part of the conversation

It is difficult to counsel patients about sexual function after pelvic reconstructive surgery because data that could guide identification of problems (and how to treat them) are incomplete. Assessingsexual function preoperatively and having an open conversation about risks and benefits of surgery, with specific mention of its impact on sexual health, are critical (see “Key touchpoints in managing sexual dysfunction after pelvic reconstructive surgery”).

It is also crucial to assess sexual function postoperatively as a matter of routine. Validated questionnaires can be a useful adjunct to a thorough history and physical exam, and can help guide your discussions.

Treatment of postop sexual dysfunction must, first, account for the complex nature of sexual function and, second, be individualized, starting with the least invasive options, when feasible. 

Cervical cancer rates remain low in the United States, with the incidence having plateaued for decades. And yet, in 2019, more than 13,000 US women will be diagnosed with cervical cancer.¹ Globally, in 2018 almost 600,000 women were diagnosed with cervical cancer²; it is the fourth most frequent cancer in women. This is despite the fact that we have adequate primary and secondary prevention tools available to minimize—and almost eliminate—cervical cancer. We must continue to raise the bar for preventing, screening for, and managing this disease.

Human papillomavirus (HPV) vaccines provide a highly effective primary prevention strategy, but we need to improve our ability to identify and diagnose dysplastic lesions prior to the development of cervical cancer. Highly sensitive HPV testing and cytology is a powerful secondary prevention approach that enables us to assess a woman’s risk of having precancerous cells both now and in the near future. These modalities have been very successful in decreasing the incidence of cervical cancer in the United States and other areas with organized screening programs. In low- and middle-income countries, however, access to, availability of, and performance with these modalities is not optimal. Innovative strategies and new technologies are being evaluated to overcome these limitations.

Advances in radiation and surgical technology have enabled us to vastly improve cervical cancer treatment. Women with early-stage cervical cancer are candidates for surgical management, which frequently includes a radical hysterectomy and lymph node dissection. While these surgeries traditionally have been performed via an exploratory laparotomy, minimally invasive techniques (laparoscopic and robot-assisted surgical techniques) have decreased the morbidity with these surgeries. Notable new studies have shed light on the comparative effectiveness of minimally invasive technologies and have shown us that new is not always better.

The US Preventive Services Task Force (USPSTF) recently released its updated cervical cancer screening guidelines. The suggested approach to screening differs from previous recommendations. HPV testing as a primary test (that is, HPV testing alone or followed by cytology) takes the spotlight now, according to the analysis by the Task Force.

In this Update, we highlight important studies published in the past year that address these issues.

Continue to: New tech's potential to identify high-grade...

New tech's potential to identify high-grade cervical dysplasia may be a boon to low-resource settings 

Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225. 

When cervical screening tests like cytology and HPV testing show abnormal results, colposcopy often is recommended. The goal of colposcopy is to identify the areas that might harbor a high-grade precancerous lesion or worse. The gold standard in this case, however, is histology, not colposcopic impression, as many studies have shown that colposcopy without biopsies is limited and that performance is improved with more biopsies.^3,4 

Visual inspection with acetic acid (VIA) is an approach used often in low-resource settings where visual impression is the gold standard. However, as with colposcopy, a visual evaluation without histology does not perform well, and often women are overtreated. Many attempts have been made with new technologies to overcome the limitations of time, cost, and workforce required for cytology and histology services. New disruptive technologies may be able to surmount human limitations and improve on not only VIA but also the need for histology. 

Novel technology uses images to develop algorithm with predictive ability 

In a recent observational study, Hu and colleagues used images that were collected during a large population study in Guanacaste, Costa Rica.⁵ More than 9,000 women were followed for up to 7 years, and cervical photographs (cervigrams) were obtained. Well-annotated histopathology results were obtained for women with abnormal screening, and 279 women had a high-grade dysplastic lesion or cancer. 

Cervigrams from women with high-grade lesions and matched controls were collected, and a deep learning-based algorithm using artificial intelligence technology was developed using 70% of the images. The remaining 30% of images were used as a validation set to test the algorithm's ability to "predict" high-grade dysplasia without knowing the final result. 

Findings. Termed automated visual evaluation (AVE), this new technology demonstrated a very accurate ability to identify high-grade dysplasia or worse, with an area under the curve (AUC) of 0.91 from merely a cervicogram (FIGURE). This outperformed conventional Pap smears (AUC, 0.71), liquid-based cytology (AUC, 0.79) and, surprisingly, highly sensitive HPV testing (AUC, 0.82) in women in the prime of their screening ages (>25 years of age). 

Continue to: Data offer persuasive evidence...

Data offer persuasive evidence to abandon minimally invasive surgery in management of early-stage cervical cancer 

Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914. 

Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904. 

Over the past decade, gynecologic cancer surgery has shifted from what routinely were open procedures to the adoption of minimally invasive techniques. Recently, a large, well-designed prospective study and a large retrospective study both demonstrated worse outcomes with minimally invasive radical hysterectomy (MIRH) as compared with traditional open radical abdominal hysterectomy (RAH). These 2 landmark studies, initially presented at the Society of Gynecologic Oncology's 2018 annual meeting and later published in the New England Journal of Medicine, have really affected the gynecologic oncology community. 

Shorter overall survival in women who had MIRH 

Melamed and colleagues conducted a large, retrospective US-based study to evaluate all-cause mortality in women with cervical cancer who underwent MIRH compared with those who had RAH.⁶ The authors also sought to evaluate national trends in 4-year relative survival rates after minimally invasive surgery was adopted. 

The study included 2,461 women who met the inclusion criteria; 49.8% (1,225) underwent MIRH procedures and, of those, 79.8% (978) had robot-assisted laparoscopy. Most women had stage IB1 tumors (88%), and most carcinomas were squamous cell (61%); 40.6% of tumors were less than 2 cm in size. There were no differences between the 2 groups with respect to rates of positive parametria, surgical margins, and lymph node involvement. Administration of adjuvant therapy, in those who qualified, was also similar between groups. 

Results. At a median follow-up of 45 months, 94 deaths occurred in the minimally invasive group and 70 in the open surgery group. The risk of death at 4 years was 9.1% in the minimally invasive group versus 5.3% in the open surgery group, with a 65% higher risk of death from any cause, which was highly statistically significant. 

Prospective trial showed MIRH was associated with lower survival rates 

From 2008 to 2017, Ramirez and colleagues conducted a phase 3, multicenter, randomized controlled trial to prospectively establish the noninferiority of MIRH compared with RAH.⁷ The study included 631 women from 33 centers. The prespecified expected disease-free survival rate was 90% at 4.5 years. 

To be included as a site, centers were required to submit details from 10 minimally invasive cases as well as 2 unedited videos for review by the trial management committee. In contrast to Melamed and colleagues' retrospective study, of the 319 procedures that were classified as minimally invasive, only 15.6% were robotically assisted. Similarly, most women had stage IB1 tumors (91.9%), and most were squamous cell carcinomas (67%). There were also no differences in the postoperative pathology findings or the need for adjuvant therapy administered between groups. The median follow-up was 2.5 years. 

Results. At that time there were 27 recurrences in the MIRH group and 7 in the RAH group; there were also 19 deaths after MIRH and 3 after RAH. Disease-free survival at 4.5 years was 86% with MIRH versus 96.5% with RAH. Reported 3-year disease-free survival and overall survival were also significantily lower in the minimally invasive subgroup (91.2% vs 97.1%, 93.8% vs 99.0%, respectively). 

Study limitations. Criticisms of this trial are that noninferiority could not be declared; in addition, the investigators were unable to complete enrollment secondary to early enrollment termination after the data and safety monitoring board raised survival concerns. 

Many argue that subgroup analyses suggest a lower risk of poor outcomes in patients with smaller tumors (<2 cm); however, it is critical to note that this study was not powered to detect these differences. 

Continue to: USPSTF updated guidance on cervical cancer screening...

USPSTF updated guidance on cervical cancer screening 

Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705. 

US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686. 

Past guidelines for cervical cancer screening have included testing for high-risk HPV (hrHPV) as a cotest with cytology or for triage of atypical squamous cells of undetermined significance (ASCUS) in women aged 30 to 65 years.⁸ The American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology, with other stakeholder organizations, issued interim guidance for primary HPV testing--that is, HPV test first and, in the case of non-16/18 hrHPV types, cytology as a triage. The most recent evidence report and systematic review by Melnikow and colleagues for the USPSTF offers an in-depth analysis of risks, benefits, harms, and value of cotesting and other management strategies.⁹ 

Focus on screening effectiveness 

Large trials of cotesting were conducted in women aged 25 to 65.^10-13 These studies all consistently showed that primary hrHPV screening led to a statistically significant increased detection of cervical intraepithelial neoplasia (CIN) 3+ in the initial round of screening, with a relative risk of detecting CIN 3+ ranging from 1.61 to 7.46 compared with cytology alone. 

Four additional studies compared cotesting with conventional cytology for the detection of CIN 3+. None of these trials demonstrated a significantly higher detection rate of CIN 3+ with cotesting compared with conventional cytology testing alone. Notably, the studies reviewed were performed in European countries that had organized screening programs in place and a nationalized health care system. Thus, these data may not be as applicable to women in the United States, particularly to women who have limited health care access. 

Risks of screening 

In the same studies reviewed for screening effectiveness, the investigators found that overall, screening with hrHPV primary or cotesting was associated with more false-positive results and higher colposcopy rates. Women screened with hrHPV alone had a 7.9% referral rate to colposcopy, while those screened with cytology had a 2.8% referral rate to colposcopy. Similarly, the rate of biopsy was higher in the hrHPV-only group (3.2% vs 1.3%). 

Overall, while cotesting might have some improvement in performance compared with hrHPV as a single modality, there might be risks of overreferral to colposcopy and overtreatment with additional cytology over hrHPV testing alone. 

This evidence review also included an analysis of more potential harms. Very limited evidence suggests that positive hrHPV test results may be associated with greater psychological harm, including decreased sexual satisfaction, increased anxiety and distress, and worse feelings about sexual partners, than abnormal cytology results. These were assessed, however, 1 to 2 weeks after the test results were provided to the patients, and long-term assessment was not done. 

New recommendations from the USPSTF 

Based on these data, the USPSTF issued new recommendations regarding screening (TABLE).¹⁴ For women aged 21 to 29, cytology alone should be used for screening every 3 years. Women aged 30 to 65 can be screened with cytology alone every 3 years, with hrHPV testing alone every 5 years, or with cotesting every 5 years.