Pelvic Floor Dysfunction

CASE

Your patient is a 26-year-old G0 woman who has a long history of progressively worsening dysmenorrhea, pelvic pain, and dyspareunia. In the recent past, she was treated with nonsteroidal anti-inflammatory drugs, a cyclic estrogen-progestin contraceptive, and a continuous estrogen-progestin contraceptive—in that order, and without appreciable relief of the pain.

Recently, the woman underwent laparoscopy, which demonstrated Stage-II endometriosis, which was ablated.

What would you prescribe for her postoperatively to alleviate symptoms?

Endometriosis will be diagnosed in approximately 8% of women of reproductive age.¹ Pelvic pain, dysmenorrhea, and deep dyspareunia are common symptoms of endometriosis that interfere with quality of life.

Endometriosis is a chronic disease best managed by developing a life-long treatment plan. Following laparoscopic diagnosis and treatment, many experts strongly recommend postoperative hormone-suppressive therapy to reduce the risk that severe pelvic pain will recur, requiring re-operation.

Options for postoperative hormonal treatment of endometriosis include:

• an estrogen–progestin contraceptive
• a progestin (norethindrone acetate [NEA]; depot medroxyprogesterone acetate [DMPA]; oral medroxyprogesterone acetate; the levonorgestrel-releasing intrauterine system [LNG-IUS; Mirena]; and the progestin-releasing implant [Implanon])
• a gonadotropin-releasing hormone (GnRH) agonist (depot leuprolide [Depot Lupron]; nafarelin nasal spray [Synarel]).

CASE Continued

Considering that both cyclic and continuous estrogen-progestin contraceptives have already failed to provide adequate pain relief for your patient, you know that you should offer an alternative to her. Taking into account that progestins are significantly less costly than a GnRH agonist, a progestin formulation might, for her, be considered a first-line postoperative treatment of symptoms of endometriosis.

Options when considering a progestin

Norethindrone acetate

This agent is available in a single formulation: a 5-mg tablet; however, dosages ranging from 2.5 mg/d (half of a tablet) to 15 mg/d have been reported to be effective for relieving pain caused by endometriosis.

What is it? NEA is an androgenic progestin that suppresses luteinizing hormone and follicle-stimulating hormone, thus reducing production of ovarian estrogen. In the absence of ovarian estrogen, endometriosis lesions atrophy. In addition, NEA binds to, and stimulates, endometrial progestin and androgen receptors, resulting in decidualization and atrophy of both eutopic and ectopic endometrial tissue.

Importantly, NEA does not appear to cause bone loss, a phenomenon that is common with agents such as the GnRH agonists or DPMA.^2-4

The research record. One randomized study, two pilot studies, and one large observational study have reported that NEA is effective for pelvic pain caused by endometriosis.

In the randomized trial, 90 women who had moderate or severe pelvic pain and rectovaginal endometriosis, and who remained symptomatic after conservative surgery, were randomized to receive NEA, 2.5 mg/d, or a low-dose estrogen-progestin contraceptive (ethinyl estradiol, 10 μg, plus cyproterone acetate, 3 mg) daily for 12 months.⁵ Both treatment groups reported significant and similar decreases in dysmenorrhea, deep dyspareunia, non-menstrual pain and dyschezia.

In a small pilot study, 40 women who had pelvic pain and colorectal endometriosis were treated with NEA 2.5 mg/d for 12 months. The drug produced significant improvement in dysmenorrhea, pelvic pain, deep dyspareunia, dyschezia, and cyclic rectal bleeding.⁶

In another pilot study, women who had pelvic pain and rectovaginal endometriosis were treated with either an aromatase inhibitor (letrozole, 2.5 mg/d) plus NEA (2.5 mg/d) or NEA (2.5 mg/d) alone for 6 months. Both treatments resulted in a significant improvement in pelvic pain and deep dyspareunia. Improvement in pain scores was greater with letrozole plus NEA; patients were more satisfied with NEA monotherapy than with the combined letrozole-NEA treatment, however, because the former was associated with fewer side effects.⁷

In a large (n=194) observational study of the postoperative use of NEA in young women with pelvic pain and endometriosis, NEA at dosages as high as 15 mg/d significantly diminished pelvic pain and self-reported menstrual bleeding. All subjects were started on a dosage of 5 mg/d, which was increased in 2.5-mg increments every 2 weeks to achieve the goals of amenorrhea and a lessening of pelvic pain; the maximum dosage administered was 15 mg/d. Mean duration of NEA use was 13 months; 75% of subjects took the maximum prescribed dosage of 15 mg at some point during treatment. The most commonly reported side effects were weight gain (16% of women); acne (10%); mood lability (9%); and vasomotor symptoms (8%).⁸

In summary. NEA is effective for treating pelvic pain caused by endometriosis at dosages from 2.5 mg/d to 15 mg/d. An important goal of treatment is a decrease in pain symptoms and amenorrhea; a dosage of 2.5 mg is often insufficient to reliably achieve both of those objectives.

In my practice I begin therapy at a dosage of 5 mg/d; the drug is effective for most patients at that dosage. If 5 mg/d does not reduce pain, I increase the dosage by 2.5 mg (half of a tablet) daily every 4 weeks, to a maximum dosage of 10 mg/d (two tablets). If that dosage is ineffective, I usually discontinue NEA and switch to a GnRH agonist.

Depot medroxyprogesterone acetate; oral medroxy-progesterone acetate

DMPA is available in two FDA-approved formulations:

• a 150-mg dose given by intramuscular injection every 3 months
• a 104-mg dose given by subcutaneous injection every 3 months.

Research. The results of two large clinical trials, comprising a total of more than 550 subjects, showed that DMPA (104 mg, SC, every 3 months) and depot leuprolide (11.25 mg, IM, every 3 months or 3.75 mg, monthly) were each equally effective in relieving dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, and pelvic induration in women who had endometriosis.^9,10

DMPA was associated with a greater rate of episodes of irregular bleeding than depot leuprolide; conversely, depot leuprolide was associated with greater loss of bone density and a higher incidence of vasomotor symptoms. Weight gain was in the range of 0.6 kg in both groups.

Of note, DPMA is much less expensive than depot leuprolide.

Another study showed that increasing the dosage of DMPA did not improve efficacy over the standard dosage¹¹: DMPA, 150 mg IM, monthly, and DMPA, 150 mg IM, every 3 months produced similar relief of pelvic pain.

Oral medroxyprogesterone acetate, prescribed at high dosages, is also effective for pelvic pain caused by endometriosis. In a pilot study (n=21), oral MPA, 50 mg/d for 4 months, alleviated dysmenorrhea, dyspareunia, pelvic pain, dyschezia, and pelvic tenderness and decreased pelvic nodularity. Sixty percent of subjects reported weight gain— 1.5 kg, on average.¹²

Progestin-releasing devices: Mirena and Implanon

Many pilot studies have reported that the levonorgestrel-releasing intrauterine system (LNG-IUS) is effective for pelvic pain caused by endometriosis.^13-17 For example:

Research. In a small clinical trial, 30 women who had pelvic pain and endometriosis were randomized to receive an LNG-IUS (Mirena) or DMPA, 150 mg IM, every 3 months for 3 years.¹³ Both therapies were effective at reducing pelvic pain.

At the conclusion of the study, more women opted to retain the LNG-IUS (87%) than to continue DMPA injection (47%). Bone density was maintained in women who had the LNG-IUS placed but slightly diminished in women receiving DMPA.

In a pilot study of an etonogestrel releasing implant (Implanon), 41 women who had pelvic pain and endometriosis were randomized to receive the implant or DMPA, 150 mg IM, every 3 months for 1 year.¹⁸ Both therapies were similarly effective at reducing pelvic pain.

Notably, irregular uterine bleeding is a common problem when the etonogestrel-releasing implant is used to treat endometriosis. Achieving amenorrhea or oligomenorrhea is an important goal for women who suffer from pelvic pain caused by endometriosis.

My recommendation

Most ObGyns see patients who are suffering from difficult-to-treat pelvic pain caused by endometriosis. Many of these patients have not had a trial of a progestin, such as NEA, DMPA, or the LNG-IUS that I use in my practice.

Progestins are, as I’ve described, effective for pelvic pain. They are also relatively inexpensive and have a side-effect profile that most patients find acceptable. I recommend that you try a progestin for your patients who have refractory pelvic pain.

CASE

Your patient is a 26-year-old G0 woman who has a long history of progressively worsening dysmenorrhea, pelvic pain, and dyspareunia. In the recent past, she was treated with nonsteroidal anti-inflammatory drugs, a cyclic estrogen-progestin contraceptive, and a continuous estrogen-progestin contraceptive—in that order, and without appreciable relief of the pain.

Recently, the woman underwent laparoscopy, which demonstrated Stage-II endometriosis, which was ablated.

What would you prescribe for her postoperatively to alleviate symptoms?

Endometriosis will be diagnosed in approximately 8% of women of reproductive age.¹ Pelvic pain, dysmenorrhea, and deep dyspareunia are common symptoms of endometriosis that interfere with quality of life.

Endometriosis is a chronic disease best managed by developing a life-long treatment plan. Following laparoscopic diagnosis and treatment, many experts strongly recommend postoperative hormone-suppressive therapy to reduce the risk that severe pelvic pain will recur, requiring re-operation.

Options for postoperative hormonal treatment of endometriosis include:

• an estrogen–progestin contraceptive
• a progestin (norethindrone acetate [NEA]; depot medroxyprogesterone acetate [DMPA]; oral medroxyprogesterone acetate; the levonorgestrel-releasing intrauterine system [LNG-IUS; Mirena]; and the progestin-releasing implant [Implanon])
• a gonadotropin-releasing hormone (GnRH) agonist (depot leuprolide [Depot Lupron]; nafarelin nasal spray [Synarel]).

CASE Continued

Considering that both cyclic and continuous estrogen-progestin contraceptives have already failed to provide adequate pain relief for your patient, you know that you should offer an alternative to her. Taking into account that progestins are significantly less costly than a GnRH agonist, a progestin formulation might, for her, be considered a first-line postoperative treatment of symptoms of endometriosis.

Options when considering a progestin

Norethindrone acetate

This agent is available in a single formulation: a 5-mg tablet; however, dosages ranging from 2.5 mg/d (half of a tablet) to 15 mg/d have been reported to be effective for relieving pain caused by endometriosis.

What is it? NEA is an androgenic progestin that suppresses luteinizing hormone and follicle-stimulating hormone, thus reducing production of ovarian estrogen. In the absence of ovarian estrogen, endometriosis lesions atrophy. In addition, NEA binds to, and stimulates, endometrial progestin and androgen receptors, resulting in decidualization and atrophy of both eutopic and ectopic endometrial tissue.

Importantly, NEA does not appear to cause bone loss, a phenomenon that is common with agents such as the GnRH agonists or DPMA.^2-4

The research record. One randomized study, two pilot studies, and one large observational study have reported that NEA is effective for pelvic pain caused by endometriosis.

In the randomized trial, 90 women who had moderate or severe pelvic pain and rectovaginal endometriosis, and who remained symptomatic after conservative surgery, were randomized to receive NEA, 2.5 mg/d, or a low-dose estrogen-progestin contraceptive (ethinyl estradiol, 10 μg, plus cyproterone acetate, 3 mg) daily for 12 months.⁵ Both treatment groups reported significant and similar decreases in dysmenorrhea, deep dyspareunia, non-menstrual pain and dyschezia.

In a small pilot study, 40 women who had pelvic pain and colorectal endometriosis were treated with NEA 2.5 mg/d for 12 months. The drug produced significant improvement in dysmenorrhea, pelvic pain, deep dyspareunia, dyschezia, and cyclic rectal bleeding.⁶

In another pilot study, women who had pelvic pain and rectovaginal endometriosis were treated with either an aromatase inhibitor (letrozole, 2.5 mg/d) plus NEA (2.5 mg/d) or NEA (2.5 mg/d) alone for 6 months. Both treatments resulted in a significant improvement in pelvic pain and deep dyspareunia. Improvement in pain scores was greater with letrozole plus NEA; patients were more satisfied with NEA monotherapy than with the combined letrozole-NEA treatment, however, because the former was associated with fewer side effects.⁷

In a large (n=194) observational study of the postoperative use of NEA in young women with pelvic pain and endometriosis, NEA at dosages as high as 15 mg/d significantly diminished pelvic pain and self-reported menstrual bleeding. All subjects were started on a dosage of 5 mg/d, which was increased in 2.5-mg increments every 2 weeks to achieve the goals of amenorrhea and a lessening of pelvic pain; the maximum dosage administered was 15 mg/d. Mean duration of NEA use was 13 months; 75% of subjects took the maximum prescribed dosage of 15 mg at some point during treatment. The most commonly reported side effects were weight gain (16% of women); acne (10%); mood lability (9%); and vasomotor symptoms (8%).⁸

In summary. NEA is effective for treating pelvic pain caused by endometriosis at dosages from 2.5 mg/d to 15 mg/d. An important goal of treatment is a decrease in pain symptoms and amenorrhea; a dosage of 2.5 mg is often insufficient to reliably achieve both of those objectives.

In my practice I begin therapy at a dosage of 5 mg/d; the drug is effective for most patients at that dosage. If 5 mg/d does not reduce pain, I increase the dosage by 2.5 mg (half of a tablet) daily every 4 weeks, to a maximum dosage of 10 mg/d (two tablets). If that dosage is ineffective, I usually discontinue NEA and switch to a GnRH agonist.

Depot medroxyprogesterone acetate; oral medroxy-progesterone acetate

DMPA is available in two FDA-approved formulations:

• a 150-mg dose given by intramuscular injection every 3 months
• a 104-mg dose given by subcutaneous injection every 3 months.

Research. The results of two large clinical trials, comprising a total of more than 550 subjects, showed that DMPA (104 mg, SC, every 3 months) and depot leuprolide (11.25 mg, IM, every 3 months or 3.75 mg, monthly) were each equally effective in relieving dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, and pelvic induration in women who had endometriosis.^9,10

DMPA was associated with a greater rate of episodes of irregular bleeding than depot leuprolide; conversely, depot leuprolide was associated with greater loss of bone density and a higher incidence of vasomotor symptoms. Weight gain was in the range of 0.6 kg in both groups.

Of note, DPMA is much less expensive than depot leuprolide.

Another study showed that increasing the dosage of DMPA did not improve efficacy over the standard dosage¹¹: DMPA, 150 mg IM, monthly, and DMPA, 150 mg IM, every 3 months produced similar relief of pelvic pain.

Oral medroxyprogesterone acetate, prescribed at high dosages, is also effective for pelvic pain caused by endometriosis. In a pilot study (n=21), oral MPA, 50 mg/d for 4 months, alleviated dysmenorrhea, dyspareunia, pelvic pain, dyschezia, and pelvic tenderness and decreased pelvic nodularity. Sixty percent of subjects reported weight gain— 1.5 kg, on average.¹²

Progestin-releasing devices: Mirena and Implanon

Many pilot studies have reported that the levonorgestrel-releasing intrauterine system (LNG-IUS) is effective for pelvic pain caused by endometriosis.^13-17 For example:

Research. In a small clinical trial, 30 women who had pelvic pain and endometriosis were randomized to receive an LNG-IUS (Mirena) or DMPA, 150 mg IM, every 3 months for 3 years.¹³ Both therapies were effective at reducing pelvic pain.

At the conclusion of the study, more women opted to retain the LNG-IUS (87%) than to continue DMPA injection (47%). Bone density was maintained in women who had the LNG-IUS placed but slightly diminished in women receiving DMPA.

In a pilot study of an etonogestrel releasing implant (Implanon), 41 women who had pelvic pain and endometriosis were randomized to receive the implant or DMPA, 150 mg IM, every 3 months for 1 year.¹⁸ Both therapies were similarly effective at reducing pelvic pain.

Notably, irregular uterine bleeding is a common problem when the etonogestrel-releasing implant is used to treat endometriosis. Achieving amenorrhea or oligomenorrhea is an important goal for women who suffer from pelvic pain caused by endometriosis.

My recommendation

Most ObGyns see patients who are suffering from difficult-to-treat pelvic pain caused by endometriosis. Many of these patients have not had a trial of a progestin, such as NEA, DMPA, or the LNG-IUS that I use in my practice.

Progestins are, as I’ve described, effective for pelvic pain. They are also relatively inexpensive and have a side-effect profile that most patients find acceptable. I recommend that you try a progestin for your patients who have refractory pelvic pain.

CASE

Your patient is a 26-year-old G0 woman who has a long history of progressively worsening dysmenorrhea, pelvic pain, and dyspareunia. In the recent past, she was treated with nonsteroidal anti-inflammatory drugs, a cyclic estrogen-progestin contraceptive, and a continuous estrogen-progestin contraceptive—in that order, and without appreciable relief of the pain.

Recently, the woman underwent laparoscopy, which demonstrated Stage-II endometriosis, which was ablated.

What would you prescribe for her postoperatively to alleviate symptoms?

Endometriosis will be diagnosed in approximately 8% of women of reproductive age.¹ Pelvic pain, dysmenorrhea, and deep dyspareunia are common symptoms of endometriosis that interfere with quality of life.

Endometriosis is a chronic disease best managed by developing a life-long treatment plan. Following laparoscopic diagnosis and treatment, many experts strongly recommend postoperative hormone-suppressive therapy to reduce the risk that severe pelvic pain will recur, requiring re-operation.

Options for postoperative hormonal treatment of endometriosis include:

• an estrogen–progestin contraceptive
• a progestin (norethindrone acetate [NEA]; depot medroxyprogesterone acetate [DMPA]; oral medroxyprogesterone acetate; the levonorgestrel-releasing intrauterine system [LNG-IUS; Mirena]; and the progestin-releasing implant [Implanon])
• a gonadotropin-releasing hormone (GnRH) agonist (depot leuprolide [Depot Lupron]; nafarelin nasal spray [Synarel]).

CASE Continued

Considering that both cyclic and continuous estrogen-progestin contraceptives have already failed to provide adequate pain relief for your patient, you know that you should offer an alternative to her. Taking into account that progestins are significantly less costly than a GnRH agonist, a progestin formulation might, for her, be considered a first-line postoperative treatment of symptoms of endometriosis.

Options when considering a progestin

Norethindrone acetate

This agent is available in a single formulation: a 5-mg tablet; however, dosages ranging from 2.5 mg/d (half of a tablet) to 15 mg/d have been reported to be effective for relieving pain caused by endometriosis.

What is it? NEA is an androgenic progestin that suppresses luteinizing hormone and follicle-stimulating hormone, thus reducing production of ovarian estrogen. In the absence of ovarian estrogen, endometriosis lesions atrophy. In addition, NEA binds to, and stimulates, endometrial progestin and androgen receptors, resulting in decidualization and atrophy of both eutopic and ectopic endometrial tissue.

Importantly, NEA does not appear to cause bone loss, a phenomenon that is common with agents such as the GnRH agonists or DPMA.^2-4

The research record. One randomized study, two pilot studies, and one large observational study have reported that NEA is effective for pelvic pain caused by endometriosis.

In the randomized trial, 90 women who had moderate or severe pelvic pain and rectovaginal endometriosis, and who remained symptomatic after conservative surgery, were randomized to receive NEA, 2.5 mg/d, or a low-dose estrogen-progestin contraceptive (ethinyl estradiol, 10 μg, plus cyproterone acetate, 3 mg) daily for 12 months.⁵ Both treatment groups reported significant and similar decreases in dysmenorrhea, deep dyspareunia, non-menstrual pain and dyschezia.

In a small pilot study, 40 women who had pelvic pain and colorectal endometriosis were treated with NEA 2.5 mg/d for 12 months. The drug produced significant improvement in dysmenorrhea, pelvic pain, deep dyspareunia, dyschezia, and cyclic rectal bleeding.⁶

In another pilot study, women who had pelvic pain and rectovaginal endometriosis were treated with either an aromatase inhibitor (letrozole, 2.5 mg/d) plus NEA (2.5 mg/d) or NEA (2.5 mg/d) alone for 6 months. Both treatments resulted in a significant improvement in pelvic pain and deep dyspareunia. Improvement in pain scores was greater with letrozole plus NEA; patients were more satisfied with NEA monotherapy than with the combined letrozole-NEA treatment, however, because the former was associated with fewer side effects.⁷

In a large (n=194) observational study of the postoperative use of NEA in young women with pelvic pain and endometriosis, NEA at dosages as high as 15 mg/d significantly diminished pelvic pain and self-reported menstrual bleeding. All subjects were started on a dosage of 5 mg/d, which was increased in 2.5-mg increments every 2 weeks to achieve the goals of amenorrhea and a lessening of pelvic pain; the maximum dosage administered was 15 mg/d. Mean duration of NEA use was 13 months; 75% of subjects took the maximum prescribed dosage of 15 mg at some point during treatment. The most commonly reported side effects were weight gain (16% of women); acne (10%); mood lability (9%); and vasomotor symptoms (8%).⁸

In summary. NEA is effective for treating pelvic pain caused by endometriosis at dosages from 2.5 mg/d to 15 mg/d. An important goal of treatment is a decrease in pain symptoms and amenorrhea; a dosage of 2.5 mg is often insufficient to reliably achieve both of those objectives.

In my practice I begin therapy at a dosage of 5 mg/d; the drug is effective for most patients at that dosage. If 5 mg/d does not reduce pain, I increase the dosage by 2.5 mg (half of a tablet) daily every 4 weeks, to a maximum dosage of 10 mg/d (two tablets). If that dosage is ineffective, I usually discontinue NEA and switch to a GnRH agonist.

Depot medroxyprogesterone acetate; oral medroxy-progesterone acetate

DMPA is available in two FDA-approved formulations:

• a 150-mg dose given by intramuscular injection every 3 months
• a 104-mg dose given by subcutaneous injection every 3 months.

Research. The results of two large clinical trials, comprising a total of more than 550 subjects, showed that DMPA (104 mg, SC, every 3 months) and depot leuprolide (11.25 mg, IM, every 3 months or 3.75 mg, monthly) were each equally effective in relieving dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, and pelvic induration in women who had endometriosis.^9,10

DMPA was associated with a greater rate of episodes of irregular bleeding than depot leuprolide; conversely, depot leuprolide was associated with greater loss of bone density and a higher incidence of vasomotor symptoms. Weight gain was in the range of 0.6 kg in both groups.

Of note, DPMA is much less expensive than depot leuprolide.

Another study showed that increasing the dosage of DMPA did not improve efficacy over the standard dosage¹¹: DMPA, 150 mg IM, monthly, and DMPA, 150 mg IM, every 3 months produced similar relief of pelvic pain.

Oral medroxyprogesterone acetate, prescribed at high dosages, is also effective for pelvic pain caused by endometriosis. In a pilot study (n=21), oral MPA, 50 mg/d for 4 months, alleviated dysmenorrhea, dyspareunia, pelvic pain, dyschezia, and pelvic tenderness and decreased pelvic nodularity. Sixty percent of subjects reported weight gain— 1.5 kg, on average.¹²

Progestin-releasing devices: Mirena and Implanon

Many pilot studies have reported that the levonorgestrel-releasing intrauterine system (LNG-IUS) is effective for pelvic pain caused by endometriosis.^13-17 For example:

Research. In a small clinical trial, 30 women who had pelvic pain and endometriosis were randomized to receive an LNG-IUS (Mirena) or DMPA, 150 mg IM, every 3 months for 3 years.¹³ Both therapies were effective at reducing pelvic pain.

At the conclusion of the study, more women opted to retain the LNG-IUS (87%) than to continue DMPA injection (47%). Bone density was maintained in women who had the LNG-IUS placed but slightly diminished in women receiving DMPA.

In a pilot study of an etonogestrel releasing implant (Implanon), 41 women who had pelvic pain and endometriosis were randomized to receive the implant or DMPA, 150 mg IM, every 3 months for 1 year.¹⁸ Both therapies were similarly effective at reducing pelvic pain.

Notably, irregular uterine bleeding is a common problem when the etonogestrel-releasing implant is used to treat endometriosis. Achieving amenorrhea or oligomenorrhea is an important goal for women who suffer from pelvic pain caused by endometriosis.

My recommendation

Most ObGyns see patients who are suffering from difficult-to-treat pelvic pain caused by endometriosis. Many of these patients have not had a trial of a progestin, such as NEA, DMPA, or the LNG-IUS that I use in my practice.

Progestins are, as I’ve described, effective for pelvic pain. They are also relatively inexpensive and have a side-effect profile that most patients find acceptable. I recommend that you try a progestin for your patients who have refractory pelvic pain.

Vague symptoms. Unexpected flares. Inconsistent manifestations. These characteristics can make diagnosis and treatment of chronic pelvic pain frustrating for both patient and physician. Most patients undergo myriad tests and studies to uncover the source of their pain—but a targeted pelvic exam may be all that is necessary to identify a prevalent but commonly overlooked cause of pelvic pain. Levator myalgia, myofascial pelvic pain syndrome, and pelvic floor spasm are all terms that describe a condition that may affect as many as 78% of women who are given a diagnosis of chronic pelvic pain.¹ This syndrome may be represented by an array of symptoms, including pelvic pressure, dyspareunia, rectal discomfort, and irritative urinary symptoms such as spasms, frequency, and urgency. It is characterized by the presence of tight, band-like pelvic muscles that reproduce the patient’s pain when palpated.²

Diagnosis of this syndrome often surprises the patient. Although the concept of a muscle spasm is not foreign, the location is unexpected. Patients and physicians alike may forget that there is a large complex of muscles that completely lines the pelvic girdle. To complicate matters, the patient often associates the onset of her symptoms with an acute event such as a “bad” urinary tract infection or pelvic or vaginal surgery, which may divert attention from the musculature. Although a muscle spasm may be the cause of the patient’s pain, it’s important to realize that an underlying process may have triggered the original spasm. To provide effective treatment of pain, therefore, you must identify the fundamental cause, assuming that it is reversible, rather than focus exclusively on symptoms.

Although there are many therapeutic options for levator myalgia, an appraisal of the extensive literature on these medications is beyond the scope of this article. Rather, we will review alternative treatment modalities and summarize the results of five trials that explored physical therapy, trigger-point or chemodenervation injection, and neuromodulation (TABLE).

Weighing the nonpharmaceutical options for treatment
of myofascial pelvic pain

Pelvic myofascial therapy offers relief—but qualified therapists may be scarce

FitzGerald MP, Anderson RU, Potts J, et al; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urology. 2009;182(2):570–580.

Physical therapy of the pelvic floor—otherwise known as pelvic myofascial therapy—requires a therapist who is highly trained and specialized in this technique. It is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers (FIGURE 1).

This pilot study by the Urological Pelvic Pain Collaborative Research Network evaluated the ability of patients to adhere to pelvic myofascial therapy, the response of their pain to therapy, and adverse events associated with manual therapy. It found that patients were willing to undergo the therapy, despite the invasive nature of the maneuvers, because it was significantly effective.

Details of the study

Patients (both men and women) were randomized to myofascial physical therapy or global therapeutic massage. Myofascial therapy consisted of internal or vaginal manipulation of the trigger-point muscle bundles and tissues of the pelvic floor. It also focused on muscles of the hip girdle and abdomen. The comparison group underwent traditional Western full-body massage. In both groups, treatment lasted 1 hour every week, and participants agreed to 10 full treatments.

Patients were eligible for the study if they experienced pelvic pain, urinary frequency, or bladder discomfort in the previous 6 months. In addition, an examiner must have been able to elicit tenderness upon palpation of the pelvic floor during examination. Patients were excluded if they showed signs of urinary tract infection or dysmenorrhea.

A total of 47 patients were randomized—24 to global massage and 23 to myofascial physical therapy. Overall, the myofascial group experienced a significantly higher rate of improvement in the global response at 12 weeks than did patients in the global-massage group (57% vs 21%; P=.03). Patients were willing to engage in myofascial pelvic therapy, and adverse events were minor.

FIGURE 1 Transvaginal myofascial therapy
Physical therapy of the pelvic floor is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers.

Need for specialized training may limit number of therapists

The randomized controlled study design renders these findings fairly reliable. Therapists were unmasked and aware of the treatment arms but were trained to make the different therapy sessions appear as similar as possible.

Although investigators were enthusiastic about their initial findings, additional studies are needed to validate the results. Moreover, these findings may be difficult to generalize because women who volunteer to participate in such a study may differ from the general population.

Nevertheless, patients who suffer from chronic pelvic pain may take heart that there is a nonpharmaceutical alternative to manage their symptoms, although availability is likely limited in many areas. Given the nature of the physical therapy required for this particular location of myofascial pain, specialized training is necessary for therapists. Despite motivated patients and well-informed providers, it may be difficult to find specialized therapists within local vicinities. Referrals to centers where this type of therapy is offered may be necessary.

The ideal agent for trigger-point injections remains a mystery

Langford CF, Udvari Nagy S, Ghoniem G M. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59–62.

Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial. Obstet Gynecol. 2006;108(4):915–923.

Trigger points are discrete, tender areas within a ridge of contracted muscle. These points may cause focal pain or referred pain upon irritation of the muscle.² Trigger-point injection therapy aims to anesthetize or relax these points by infiltrating the muscle with medications.

These two studies evaluated the value of trigger-point injections in the treatment of pelvic myofascial pain; they found that the injections provide relief, although the mechanism of action and the ideal agent remain to be determined.

Langford et al: Details of the study

In this prospective study, 18 women who had pelvic pain of at least 6 months’ duration and confirmed trigger points on examination underwent transvaginal injection of a solution of bupivacaine, lidocaine, and triamcinolone. They were assessed by questionnaire at baseline and 3 months after injection. Assessment included a visual analog scale for pain severity. Investigators defined success as a decrease in pain of 50% or more and global-satisfaction and global-cure visual scores of 60% or higher.

Thirteen of the 18 women (72.2%) improved after their first injection, with six women reporting a complete absence of pain. Overall, women reported significant decreases in pain and increases in the rates of satisfaction and cure, meeting the definition of success at 3 months after the injection.

Among the theories proposed to explain the mechanism of action of trigger-point injections are:

• disruption of reflex arcs within skeletal muscle
• release of endorphins
• mechanical changes in abnormally contracted muscle fibers.

This last theory highlights one of the limitations of this study—lack of a placebo arm. Could it be possible that the injection of any fluid produces the same effect?

This study was not designed to investigate the causal relationship between the injection of a particular solution and pain relief, but it does highlight the need for studies to clarify the mechanism of action, including use of a placebo. It also prompts questions about the duration of effect after a single injection.

Goal of chemodenervation is blocking of muscle activity

Botulinum toxin type A (Botox) blocks the release of acetylcholine from presynaptic neurons. The release of acetylcholine stimulates muscle contractions; therefore, blockage of its release reduces muscle activity. This type of chemodenervation has found widespread use, and botulinum toxin A now has approval from the Food and Drug Administration (FDA) for treatment of chronic migraine, limb spasticity, cervical dystonia, strabismus, hyperhidrosis, and facial cosmesis.³ Although it is not approved for pelvic floor levator spasm, its success in treating other myotonic disorders suggests that its application may be relevant.

Abbott et al: Details of the study

Abbott and colleagues performed a double-blind, randomized, controlled trial to compare injection of botulinum toxin A with injection of saline. They measured changes in the pain scale, quality of life, and vaginal pressure.

Women were eligible for the study if they had subjectively reported pelvic pain of more than 2 years’ duration and objective evidence of trigger points (on examination) and elevated vaginal resting pressure (by vaginal manometry). Neither the clinical research staff nor the patient knew the contents of the injections, but all women received a total of four—two at sites in the puborectalis muscle and two in the pubococcygeus muscle.

After periodic assessment by questionnaire and examination through 6 months after injection, no differences were found in the pain score or resting vaginal pressure between the group of women who received botulinum toxin A and the group who received placebo. However, each group experienced a significant reduction in pain and vaginal pressure, compared with baseline. And both groups reported improved quality of life, compared with baseline. Neither group reported voiding dysfunction.

Neuromodulation shows promise as treatment for pelvic myofascial pain

van Balken MR, Vandoninck V, Messelink, BJ, et al. Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol. 2003;43(2):158–163.

Zabihi N, Mourtzinos A, Maher MG, Raz S, Rodriguez LV. Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(4):553–557.

Neuromodulation is the science of using electrical impulses to alter neuronal activities. The exact mechanisms of action are unclear, but the technology has been utilized to control symptoms of overactive bladder and urinary retention caused by poor relaxation of the urethral and pelvic floor muscles. While studying the effects of sacral nerve root neuromodulation on the bladder, investigators noted improvements in other symptoms, such as pelvic pain.

Neuromodulation of the sacral nerve roots may be achieved by direct conduction of electrical impulses from a lead implanted in the sacrum (sacral neuromodulation) or by the retrograde conduction of these impulses through the posterior tibial nerve (percutaneous tibial nerve stimulation, or PTNS) (FIGURE 2). The tibial nerve arises from sacral nerves L5 to S3 and is one of the larger branches of the sciatic nerve.

FIGURE 2 InterStim therapy
Stimulation of the sacral nerve has been used successfully to manage overactive bladder and urinary retention and may prove useful in the treatment of pelvic myofascial pain.

Van Balken et al: Details of the study

In this prospective observational study, 33 patients (both male and female) who had chronic pelvic pain by history and examination were treated with weekly, 30-minute outpatient sessions of PTNS for 12 weeks. Participants were asked to provide baseline pain scores and keep a diary of their pain. Quality-of-life questionnaires were also administered at baseline and at 12 weeks.

Investigators considered both subjective and objective success in their outcomes. If a patient elected to continue therapy, he or she was classified as a subjective success. Objective success required a decrease of at least 50% in the pain score. At the end of 12 weeks, although 33 patients (42%) wanted to continue therapy, only seven (21%) met the definition for objective success. Of those seven, six elected to continue therapy.

This study sheds light on a treatment modality that has not been studied adequately for the indication of pelvic pain but that may be promising in patients who have levator myalgia. Limitations of this study include the lack of a placebo arm, short-term outcome, and lack of localization of pain. Furthermore, although PTNS has FDA approval for treatment of urinary urgency, frequency, and urge incontinence, it is not approved for the treatment of pelvic pain. These preliminary findings demonstrate potential but, as with any new indication, long-term comparative studies are needed.

Zabihi et al: Details of the study

Patients in this retrospective study had a diagnosis of interstitial cystitis or chronic pelvic pain. Pelvic myofascial pain and trigger points were not required for eligibility. Thirty patients (21 women and nine men) had temporary placement of a lead containing four small electrodes along the S2 to S4 sacral nerve roots on both sides of the sacrum. They were then followed for a trial period of 2 to 4 weeks. To qualify for the final stage of the study, in which the leads were connected internally to a generator implanted in the buttocks, patients had to report improvement of at least 50% in their symptoms. If their improvement did not meet that threshold, the leads were removed.

Twenty-three patients (77%) met the criteria for permanent implantation. Of these patients, 42% reported improvement of more than 50% at 6 postoperative months. Quality-of-life scores also improved significantly.

Sacral neuromodulation is not FDA-approved for the treatment of chronic pelvic pain; further studies are needed before it can be recommended for this indication.

We want to hear from you! Tell us what you think.

Vague symptoms. Unexpected flares. Inconsistent manifestations. These characteristics can make diagnosis and treatment of chronic pelvic pain frustrating for both patient and physician. Most patients undergo myriad tests and studies to uncover the source of their pain—but a targeted pelvic exam may be all that is necessary to identify a prevalent but commonly overlooked cause of pelvic pain. Levator myalgia, myofascial pelvic pain syndrome, and pelvic floor spasm are all terms that describe a condition that may affect as many as 78% of women who are given a diagnosis of chronic pelvic pain.¹ This syndrome may be represented by an array of symptoms, including pelvic pressure, dyspareunia, rectal discomfort, and irritative urinary symptoms such as spasms, frequency, and urgency. It is characterized by the presence of tight, band-like pelvic muscles that reproduce the patient’s pain when palpated.²

Diagnosis of this syndrome often surprises the patient. Although the concept of a muscle spasm is not foreign, the location is unexpected. Patients and physicians alike may forget that there is a large complex of muscles that completely lines the pelvic girdle. To complicate matters, the patient often associates the onset of her symptoms with an acute event such as a “bad” urinary tract infection or pelvic or vaginal surgery, which may divert attention from the musculature. Although a muscle spasm may be the cause of the patient’s pain, it’s important to realize that an underlying process may have triggered the original spasm. To provide effective treatment of pain, therefore, you must identify the fundamental cause, assuming that it is reversible, rather than focus exclusively on symptoms.

Although there are many therapeutic options for levator myalgia, an appraisal of the extensive literature on these medications is beyond the scope of this article. Rather, we will review alternative treatment modalities and summarize the results of five trials that explored physical therapy, trigger-point or chemodenervation injection, and neuromodulation (TABLE).

Weighing the nonpharmaceutical options for treatment
of myofascial pelvic pain

Pelvic myofascial therapy offers relief—but qualified therapists may be scarce

FitzGerald MP, Anderson RU, Potts J, et al; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urology. 2009;182(2):570–580.

Physical therapy of the pelvic floor—otherwise known as pelvic myofascial therapy—requires a therapist who is highly trained and specialized in this technique. It is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers (FIGURE 1).

This pilot study by the Urological Pelvic Pain Collaborative Research Network evaluated the ability of patients to adhere to pelvic myofascial therapy, the response of their pain to therapy, and adverse events associated with manual therapy. It found that patients were willing to undergo the therapy, despite the invasive nature of the maneuvers, because it was significantly effective.

Details of the study

Patients (both men and women) were randomized to myofascial physical therapy or global therapeutic massage. Myofascial therapy consisted of internal or vaginal manipulation of the trigger-point muscle bundles and tissues of the pelvic floor. It also focused on muscles of the hip girdle and abdomen. The comparison group underwent traditional Western full-body massage. In both groups, treatment lasted 1 hour every week, and participants agreed to 10 full treatments.

Patients were eligible for the study if they experienced pelvic pain, urinary frequency, or bladder discomfort in the previous 6 months. In addition, an examiner must have been able to elicit tenderness upon palpation of the pelvic floor during examination. Patients were excluded if they showed signs of urinary tract infection or dysmenorrhea.

A total of 47 patients were randomized—24 to global massage and 23 to myofascial physical therapy. Overall, the myofascial group experienced a significantly higher rate of improvement in the global response at 12 weeks than did patients in the global-massage group (57% vs 21%; P=.03). Patients were willing to engage in myofascial pelvic therapy, and adverse events were minor.

FIGURE 1 Transvaginal myofascial therapy
Physical therapy of the pelvic floor is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers.

Need for specialized training may limit number of therapists

The randomized controlled study design renders these findings fairly reliable. Therapists were unmasked and aware of the treatment arms but were trained to make the different therapy sessions appear as similar as possible.

Although investigators were enthusiastic about their initial findings, additional studies are needed to validate the results. Moreover, these findings may be difficult to generalize because women who volunteer to participate in such a study may differ from the general population.

Nevertheless, patients who suffer from chronic pelvic pain may take heart that there is a nonpharmaceutical alternative to manage their symptoms, although availability is likely limited in many areas. Given the nature of the physical therapy required for this particular location of myofascial pain, specialized training is necessary for therapists. Despite motivated patients and well-informed providers, it may be difficult to find specialized therapists within local vicinities. Referrals to centers where this type of therapy is offered may be necessary.

The ideal agent for trigger-point injections remains a mystery

Langford CF, Udvari Nagy S, Ghoniem G M. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59–62.

Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial. Obstet Gynecol. 2006;108(4):915–923.

Trigger points are discrete, tender areas within a ridge of contracted muscle. These points may cause focal pain or referred pain upon irritation of the muscle.² Trigger-point injection therapy aims to anesthetize or relax these points by infiltrating the muscle with medications.

These two studies evaluated the value of trigger-point injections in the treatment of pelvic myofascial pain; they found that the injections provide relief, although the mechanism of action and the ideal agent remain to be determined.

Langford et al: Details of the study

In this prospective study, 18 women who had pelvic pain of at least 6 months’ duration and confirmed trigger points on examination underwent transvaginal injection of a solution of bupivacaine, lidocaine, and triamcinolone. They were assessed by questionnaire at baseline and 3 months after injection. Assessment included a visual analog scale for pain severity. Investigators defined success as a decrease in pain of 50% or more and global-satisfaction and global-cure visual scores of 60% or higher.

Thirteen of the 18 women (72.2%) improved after their first injection, with six women reporting a complete absence of pain. Overall, women reported significant decreases in pain and increases in the rates of satisfaction and cure, meeting the definition of success at 3 months after the injection.

Among the theories proposed to explain the mechanism of action of trigger-point injections are:

• disruption of reflex arcs within skeletal muscle
• release of endorphins
• mechanical changes in abnormally contracted muscle fibers.

This last theory highlights one of the limitations of this study—lack of a placebo arm. Could it be possible that the injection of any fluid produces the same effect?

This study was not designed to investigate the causal relationship between the injection of a particular solution and pain relief, but it does highlight the need for studies to clarify the mechanism of action, including use of a placebo. It also prompts questions about the duration of effect after a single injection.

Goal of chemodenervation is blocking of muscle activity

Botulinum toxin type A (Botox) blocks the release of acetylcholine from presynaptic neurons. The release of acetylcholine stimulates muscle contractions; therefore, blockage of its release reduces muscle activity. This type of chemodenervation has found widespread use, and botulinum toxin A now has approval from the Food and Drug Administration (FDA) for treatment of chronic migraine, limb spasticity, cervical dystonia, strabismus, hyperhidrosis, and facial cosmesis.³ Although it is not approved for pelvic floor levator spasm, its success in treating other myotonic disorders suggests that its application may be relevant.

Abbott et al: Details of the study

Abbott and colleagues performed a double-blind, randomized, controlled trial to compare injection of botulinum toxin A with injection of saline. They measured changes in the pain scale, quality of life, and vaginal pressure.

Women were eligible for the study if they had subjectively reported pelvic pain of more than 2 years’ duration and objective evidence of trigger points (on examination) and elevated vaginal resting pressure (by vaginal manometry). Neither the clinical research staff nor the patient knew the contents of the injections, but all women received a total of four—two at sites in the puborectalis muscle and two in the pubococcygeus muscle.

After periodic assessment by questionnaire and examination through 6 months after injection, no differences were found in the pain score or resting vaginal pressure between the group of women who received botulinum toxin A and the group who received placebo. However, each group experienced a significant reduction in pain and vaginal pressure, compared with baseline. And both groups reported improved quality of life, compared with baseline. Neither group reported voiding dysfunction.

Neuromodulation shows promise as treatment for pelvic myofascial pain

van Balken MR, Vandoninck V, Messelink, BJ, et al. Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol. 2003;43(2):158–163.

Zabihi N, Mourtzinos A, Maher MG, Raz S, Rodriguez LV. Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(4):553–557.

Neuromodulation is the science of using electrical impulses to alter neuronal activities. The exact mechanisms of action are unclear, but the technology has been utilized to control symptoms of overactive bladder and urinary retention caused by poor relaxation of the urethral and pelvic floor muscles. While studying the effects of sacral nerve root neuromodulation on the bladder, investigators noted improvements in other symptoms, such as pelvic pain.

Neuromodulation of the sacral nerve roots may be achieved by direct conduction of electrical impulses from a lead implanted in the sacrum (sacral neuromodulation) or by the retrograde conduction of these impulses through the posterior tibial nerve (percutaneous tibial nerve stimulation, or PTNS) (FIGURE 2). The tibial nerve arises from sacral nerves L5 to S3 and is one of the larger branches of the sciatic nerve.

FIGURE 2 InterStim therapy
Stimulation of the sacral nerve has been used successfully to manage overactive bladder and urinary retention and may prove useful in the treatment of pelvic myofascial pain.

Van Balken et al: Details of the study

In this prospective observational study, 33 patients (both male and female) who had chronic pelvic pain by history and examination were treated with weekly, 30-minute outpatient sessions of PTNS for 12 weeks. Participants were asked to provide baseline pain scores and keep a diary of their pain. Quality-of-life questionnaires were also administered at baseline and at 12 weeks.

Investigators considered both subjective and objective success in their outcomes. If a patient elected to continue therapy, he or she was classified as a subjective success. Objective success required a decrease of at least 50% in the pain score. At the end of 12 weeks, although 33 patients (42%) wanted to continue therapy, only seven (21%) met the definition for objective success. Of those seven, six elected to continue therapy.

This study sheds light on a treatment modality that has not been studied adequately for the indication of pelvic pain but that may be promising in patients who have levator myalgia. Limitations of this study include the lack of a placebo arm, short-term outcome, and lack of localization of pain. Furthermore, although PTNS has FDA approval for treatment of urinary urgency, frequency, and urge incontinence, it is not approved for the treatment of pelvic pain. These preliminary findings demonstrate potential but, as with any new indication, long-term comparative studies are needed.

Zabihi et al: Details of the study

Patients in this retrospective study had a diagnosis of interstitial cystitis or chronic pelvic pain. Pelvic myofascial pain and trigger points were not required for eligibility. Thirty patients (21 women and nine men) had temporary placement of a lead containing four small electrodes along the S2 to S4 sacral nerve roots on both sides of the sacrum. They were then followed for a trial period of 2 to 4 weeks. To qualify for the final stage of the study, in which the leads were connected internally to a generator implanted in the buttocks, patients had to report improvement of at least 50% in their symptoms. If their improvement did not meet that threshold, the leads were removed.

Twenty-three patients (77%) met the criteria for permanent implantation. Of these patients, 42% reported improvement of more than 50% at 6 postoperative months. Quality-of-life scores also improved significantly.

Sacral neuromodulation is not FDA-approved for the treatment of chronic pelvic pain; further studies are needed before it can be recommended for this indication.

We want to hear from you! Tell us what you think.

Vague symptoms. Unexpected flares. Inconsistent manifestations. These characteristics can make diagnosis and treatment of chronic pelvic pain frustrating for both patient and physician. Most patients undergo myriad tests and studies to uncover the source of their pain—but a targeted pelvic exam may be all that is necessary to identify a prevalent but commonly overlooked cause of pelvic pain. Levator myalgia, myofascial pelvic pain syndrome, and pelvic floor spasm are all terms that describe a condition that may affect as many as 78% of women who are given a diagnosis of chronic pelvic pain.¹ This syndrome may be represented by an array of symptoms, including pelvic pressure, dyspareunia, rectal discomfort, and irritative urinary symptoms such as spasms, frequency, and urgency. It is characterized by the presence of tight, band-like pelvic muscles that reproduce the patient’s pain when palpated.²

Diagnosis of this syndrome often surprises the patient. Although the concept of a muscle spasm is not foreign, the location is unexpected. Patients and physicians alike may forget that there is a large complex of muscles that completely lines the pelvic girdle. To complicate matters, the patient often associates the onset of her symptoms with an acute event such as a “bad” urinary tract infection or pelvic or vaginal surgery, which may divert attention from the musculature. Although a muscle spasm may be the cause of the patient’s pain, it’s important to realize that an underlying process may have triggered the original spasm. To provide effective treatment of pain, therefore, you must identify the fundamental cause, assuming that it is reversible, rather than focus exclusively on symptoms.

Although there are many therapeutic options for levator myalgia, an appraisal of the extensive literature on these medications is beyond the scope of this article. Rather, we will review alternative treatment modalities and summarize the results of five trials that explored physical therapy, trigger-point or chemodenervation injection, and neuromodulation (TABLE).

Weighing the nonpharmaceutical options for treatment
of myofascial pelvic pain

Pelvic myofascial therapy offers relief—but qualified therapists may be scarce

FitzGerald MP, Anderson RU, Potts J, et al; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urology. 2009;182(2):570–580.

Physical therapy of the pelvic floor—otherwise known as pelvic myofascial therapy—requires a therapist who is highly trained and specialized in this technique. It is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers (FIGURE 1).

This pilot study by the Urological Pelvic Pain Collaborative Research Network evaluated the ability of patients to adhere to pelvic myofascial therapy, the response of their pain to therapy, and adverse events associated with manual therapy. It found that patients were willing to undergo the therapy, despite the invasive nature of the maneuvers, because it was significantly effective.

Details of the study

Patients (both men and women) were randomized to myofascial physical therapy or global therapeutic massage. Myofascial therapy consisted of internal or vaginal manipulation of the trigger-point muscle bundles and tissues of the pelvic floor. It also focused on muscles of the hip girdle and abdomen. The comparison group underwent traditional Western full-body massage. In both groups, treatment lasted 1 hour every week, and participants agreed to 10 full treatments.

Patients were eligible for the study if they experienced pelvic pain, urinary frequency, or bladder discomfort in the previous 6 months. In addition, an examiner must have been able to elicit tenderness upon palpation of the pelvic floor during examination. Patients were excluded if they showed signs of urinary tract infection or dysmenorrhea.

A total of 47 patients were randomized—24 to global massage and 23 to myofascial physical therapy. Overall, the myofascial group experienced a significantly higher rate of improvement in the global response at 12 weeks than did patients in the global-massage group (57% vs 21%; P=.03). Patients were willing to engage in myofascial pelvic therapy, and adverse events were minor.

FIGURE 1 Transvaginal myofascial therapy
Physical therapy of the pelvic floor is more invasive than other forms of rehabilitative therapy because of the need to perform transvaginal maneuvers.

Need for specialized training may limit number of therapists

The randomized controlled study design renders these findings fairly reliable. Therapists were unmasked and aware of the treatment arms but were trained to make the different therapy sessions appear as similar as possible.

Although investigators were enthusiastic about their initial findings, additional studies are needed to validate the results. Moreover, these findings may be difficult to generalize because women who volunteer to participate in such a study may differ from the general population.

Nevertheless, patients who suffer from chronic pelvic pain may take heart that there is a nonpharmaceutical alternative to manage their symptoms, although availability is likely limited in many areas. Given the nature of the physical therapy required for this particular location of myofascial pain, specialized training is necessary for therapists. Despite motivated patients and well-informed providers, it may be difficult to find specialized therapists within local vicinities. Referrals to centers where this type of therapy is offered may be necessary.

The ideal agent for trigger-point injections remains a mystery

Langford CF, Udvari Nagy S, Ghoniem G M. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59–62.

Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial. Obstet Gynecol. 2006;108(4):915–923.

Trigger points are discrete, tender areas within a ridge of contracted muscle. These points may cause focal pain or referred pain upon irritation of the muscle.² Trigger-point injection therapy aims to anesthetize or relax these points by infiltrating the muscle with medications.

These two studies evaluated the value of trigger-point injections in the treatment of pelvic myofascial pain; they found that the injections provide relief, although the mechanism of action and the ideal agent remain to be determined.

Langford et al: Details of the study

In this prospective study, 18 women who had pelvic pain of at least 6 months’ duration and confirmed trigger points on examination underwent transvaginal injection of a solution of bupivacaine, lidocaine, and triamcinolone. They were assessed by questionnaire at baseline and 3 months after injection. Assessment included a visual analog scale for pain severity. Investigators defined success as a decrease in pain of 50% or more and global-satisfaction and global-cure visual scores of 60% or higher.

Thirteen of the 18 women (72.2%) improved after their first injection, with six women reporting a complete absence of pain. Overall, women reported significant decreases in pain and increases in the rates of satisfaction and cure, meeting the definition of success at 3 months after the injection.

Among the theories proposed to explain the mechanism of action of trigger-point injections are:

• disruption of reflex arcs within skeletal muscle
• release of endorphins
• mechanical changes in abnormally contracted muscle fibers.

This last theory highlights one of the limitations of this study—lack of a placebo arm. Could it be possible that the injection of any fluid produces the same effect?

This study was not designed to investigate the causal relationship between the injection of a particular solution and pain relief, but it does highlight the need for studies to clarify the mechanism of action, including use of a placebo. It also prompts questions about the duration of effect after a single injection.

Goal of chemodenervation is blocking of muscle activity

Botulinum toxin type A (Botox) blocks the release of acetylcholine from presynaptic neurons. The release of acetylcholine stimulates muscle contractions; therefore, blockage of its release reduces muscle activity. This type of chemodenervation has found widespread use, and botulinum toxin A now has approval from the Food and Drug Administration (FDA) for treatment of chronic migraine, limb spasticity, cervical dystonia, strabismus, hyperhidrosis, and facial cosmesis.³ Although it is not approved for pelvic floor levator spasm, its success in treating other myotonic disorders suggests that its application may be relevant.

Abbott et al: Details of the study

Abbott and colleagues performed a double-blind, randomized, controlled trial to compare injection of botulinum toxin A with injection of saline. They measured changes in the pain scale, quality of life, and vaginal pressure.

Women were eligible for the study if they had subjectively reported pelvic pain of more than 2 years’ duration and objective evidence of trigger points (on examination) and elevated vaginal resting pressure (by vaginal manometry). Neither the clinical research staff nor the patient knew the contents of the injections, but all women received a total of four—two at sites in the puborectalis muscle and two in the pubococcygeus muscle.

After periodic assessment by questionnaire and examination through 6 months after injection, no differences were found in the pain score or resting vaginal pressure between the group of women who received botulinum toxin A and the group who received placebo. However, each group experienced a significant reduction in pain and vaginal pressure, compared with baseline. And both groups reported improved quality of life, compared with baseline. Neither group reported voiding dysfunction.

Neuromodulation shows promise as treatment for pelvic myofascial pain

van Balken MR, Vandoninck V, Messelink, BJ, et al. Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol. 2003;43(2):158–163.

Zabihi N, Mourtzinos A, Maher MG, Raz S, Rodriguez LV. Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(4):553–557.

Neuromodulation is the science of using electrical impulses to alter neuronal activities. The exact mechanisms of action are unclear, but the technology has been utilized to control symptoms of overactive bladder and urinary retention caused by poor relaxation of the urethral and pelvic floor muscles. While studying the effects of sacral nerve root neuromodulation on the bladder, investigators noted improvements in other symptoms, such as pelvic pain.

Neuromodulation of the sacral nerve roots may be achieved by direct conduction of electrical impulses from a lead implanted in the sacrum (sacral neuromodulation) or by the retrograde conduction of these impulses through the posterior tibial nerve (percutaneous tibial nerve stimulation, or PTNS) (FIGURE 2). The tibial nerve arises from sacral nerves L5 to S3 and is one of the larger branches of the sciatic nerve.

FIGURE 2 InterStim therapy
Stimulation of the sacral nerve has been used successfully to manage overactive bladder and urinary retention and may prove useful in the treatment of pelvic myofascial pain.

Van Balken et al: Details of the study

In this prospective observational study, 33 patients (both male and female) who had chronic pelvic pain by history and examination were treated with weekly, 30-minute outpatient sessions of PTNS for 12 weeks. Participants were asked to provide baseline pain scores and keep a diary of their pain. Quality-of-life questionnaires were also administered at baseline and at 12 weeks.

Investigators considered both subjective and objective success in their outcomes. If a patient elected to continue therapy, he or she was classified as a subjective success. Objective success required a decrease of at least 50% in the pain score. At the end of 12 weeks, although 33 patients (42%) wanted to continue therapy, only seven (21%) met the definition for objective success. Of those seven, six elected to continue therapy.

This study sheds light on a treatment modality that has not been studied adequately for the indication of pelvic pain but that may be promising in patients who have levator myalgia. Limitations of this study include the lack of a placebo arm, short-term outcome, and lack of localization of pain. Furthermore, although PTNS has FDA approval for treatment of urinary urgency, frequency, and urge incontinence, it is not approved for the treatment of pelvic pain. These preliminary findings demonstrate potential but, as with any new indication, long-term comparative studies are needed.

Zabihi et al: Details of the study

Patients in this retrospective study had a diagnosis of interstitial cystitis or chronic pelvic pain. Pelvic myofascial pain and trigger points were not required for eligibility. Thirty patients (21 women and nine men) had temporary placement of a lead containing four small electrodes along the S2 to S4 sacral nerve roots on both sides of the sacrum. They were then followed for a trial period of 2 to 4 weeks. To qualify for the final stage of the study, in which the leads were connected internally to a generator implanted in the buttocks, patients had to report improvement of at least 50% in their symptoms. If their improvement did not meet that threshold, the leads were removed.

Twenty-three patients (77%) met the criteria for permanent implantation. Of these patients, 42% reported improvement of more than 50% at 6 postoperative months. Quality-of-life scores also improved significantly.

Sacral neuromodulation is not FDA-approved for the treatment of chronic pelvic pain; further studies are needed before it can be recommended for this indication.

We want to hear from you! Tell us what you think.

When a woman has advanced prolapse of the anterior vaginal wall, it is highly likely that she has apical prolapse as well. Consider a study by Rooney and associates that determined that clinically significant vault prolapse is present in most women who have anterior vaginal prolapse of stage II or higher.¹ For that reason, suspension of the vaginal apex should be considered whenever surgical treatment of anterior wall defects is planned.

Sacrocolpopexy involves suspension of the vaginal vault from the anterior longitudinal ligament of the sacrum, using Y-shaped mesh to augment native tissue (FIGURE).² It is an effective, durable treatment for vaginal apical prolapse. With a success rate approaching 93%, this procedure has become the gold standard for repair of vault prolapse. Among its advantages are maximization of vaginal depth and preservation of a normal vaginal axis.

Sacrocolpopexy preserves the vaginal axis

With the vaginal vault suspended from the anterior longitudinal
ligament of the sacrum, the normal vaginal axis is preserved
and vaginal depth is maximized.

Sacrocolpopexy can be performed via the abdominal, laparoscopic, or robotic-assisted approach (TABLE 1). Minimally invasive techniques are attractive because they involve faster recovery than abdominal sacrocolpopexy does. Minimally invasive techniques have also advanced to the point that they are both effective and durable. However, these advantages must be weighed against the effort required to learn the techniques, as well as their higher cost.

TABLE 1

How the 3 approaches to sacrocolpopexy compare

In this article, we highlight:

• a comparison of the laparoscopic and abdominal approaches to sacrocolpopexy
• an investigation of the learning curve associated with robotic-assisted sacrocolpopexy
• a study exploring the durability of robotic-assisted repair
• an estimate of the costs associated with each route of operation.

Laparoscopic vs abdominal sacrocolpopexy—how do they compare?

Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005;192(5):1752–1758.

When surgeons at the Cleveland Clinic performed a retrospective cohort study to compare laparoscopic and abdominal sacrocolpopexy, they found significantly longer operative time with the laparoscopic route, with an average difference of 51 minutes (P < .0001). However, the laparoscopic approach was associated with lower blood loss (although there was no difference between groups in hematocrit on postoperative day 1); shorter hospital stay (average of 1.8 days versus 4 days [P < .001]); and comparable rates of intraoperative and postoperative complications.

Details of the trial

Paraiso and colleagues reviewed the medical charts of 56 consecutive patients who had undergone laparoscopic sacrocolpopexy, comparing them with the charts of 61 consecutive patients who had undergone the procedure using the abdominal approach. The operations had been performed between 1998 and 2003 for treatment of posthysterectomy vaginal prolapse.

The groups underwent similar rates of concurrent procedures. The laparotomy group had a significantly higher number of Burch procedures (P = .007), and the laparoscopic group had a significantly higher rate of adhesiolysis (P = .002).

Among the complications noted— which occurred at comparable rates between groups—were cystotomy, enterotomy, need for transfusion, deep-vein thrombosis, ileus, small bowel obstruction, wound infection, ventral hernia, mesh erosion, and recurrent prolapse. One laparoscopic case was converted to laparotomy because of excessive bleeding during the rectopexy portion of the operation.

Laparoscopy may have taken longer than this trial suggests

This study is one of very few well-designed trials comparing laparoscopic sacrocolpopexy to the historical gold standard of abdominal sacrocolpopexy for vault prolapse.

Twenty-eight percent of laparoscopic procedures in this study used tacking devices in lieu of suturing. Had suturing been performed universally, an even greater difference in surgical time may have been observed.

There may also be differences between groups in the durability of the two types of repair, an outcome not included in this particular study.

How steep is the learning curve for robotic-assisted sacrocolpopexy?

Akl MN, Long JB, Giles DL, et al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc. 2009;23(10):2390–2394.

Akl and coworkers reviewed the medical records of all patients who had undergone robotic-assisted sacrocolpopexy at the Mayo Clinics in Arizona and Florida between 2004 and 2007. All operations were performed by the same four urogynecologists, with an average operative time of 197.9 minutes (standard deviation, ± 66.8 minutes). However, after the first 10 cases, the operative time decreased by 64.3 minutes—a decline of 25.4% (P < .01; 95% confidence interval [CI], 16.1–112.4 minutes).

Details of the trial

Researchers collected baseline information on participants’ age, stage of prolapse, and concomitant procedures. They also gathered data on average operative time, estimated blood loss, intraoperative and postoperative complications, conversion to laparotomy, and length of hospitalization.

Of 80 women who had advanced pelvic organ prolapse (stage III/IV) who underwent robotic-assisted sacrocolpopexy, 88% underwent concomitant robotic and vaginal procedures, including robotic supracervical hysterectomy, Burch procedure, paravaginal repair, lysis of adhesions, bilateral salpingooophorectomy, vaginal cystocele or rectocele repair, and placement of a midurethral sling.

Estimated blood loss for the robotic-assisted approach ranged from 25 mL to 300 mL, with a mean loss of 96.8 mL. Average length of hospitalization was 2.6 days. Four cases (5%) were converted to laparotomy because of limited exposure and one intraoperative bladder injury. Other intraoperative complications included small-bowel injury during trocar placement and one ureteral injury. Postoperative complications included one case of ileus and five (6%) vaginal mesh erosions. Three patients developed recurrent prolapse and underwent subsequent correction.

Learning curve could have been measured more precisely

The authors did not specifically measure the learning curve for robotic-assisted sacrocolpopexy, as they took into account the concomitant procedures. For this reason, the decrease in operative time observed after 10 cases may not accurately reflect an improvement in the performance of sacrocolpopexy.

Akl and colleagues consider this detail to be a strength of the study because most women who undergo prolapse surgery have concomitant procedures. However, recording the length of time it took to perform the sacrocolpopexy portion of the procedure would have been more accurate.

The average length of stay approached that of the abdominal route. Length of stay may decline as a surgeon gains experience with the robotic-assisted approach.

Does robotic-assisted sacrocolpopexy provide durable support?

Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006;176(2):655–659.

Among the few recent series reporting long-term outcomes after robotic-assisted sacrocolpopexy is this observational study from the Mayo Clinic. It involved 30 women who underwent the operation for the treatment of Baden Walker grade 4/4 posthysterectomy vaginal vault prolapse. The authors concluded that advanced prolapse can be treated with robotic-assisted sacrocolpopexy with long-term success and minimal complications.

Details of the trial

Of 30 women in this trial, 52% underwent an anti-incontinence procedure at the time of sacrocolpopexy. Women who had multiple vaginal defects or a history of abdominal surgery were excluded from the study.

Average operative time was 3.1 hours (range, 2.15–4.75 hours) in the early phase of development of operative technique (described in the manuscript) but diminished over time to an average of 2.5 hours.

Twenty-nine patients were discharged from the hospital after an overnight stay. Very few immediate postoperative complications were observed. Two patients experienced mild port-site infections that required outpatient treatment, and one patient had persistent vaginal bleeding from the incision made during the anti-incontinence procedure.

Most patients were followed for at least 1 year

The mean follow-up in this study was 24 months (range, 16–39 months). During this period, 21 women were followed for a full year. Long-term observation revealed that the repair of vault prolapse remained successful in 19 of these women.

One patient experienced recurrent prolapse 7 months after surgery. Another developed a rectocele 9 months after sacrocolpopexy. Vaginal mesh erosions occurred in two patients within 6 months after the procedure; both patients were treated with outpatient resection of the exposed mesh, with no recurrence of the prolapse.

Although a larger sample size and longer follow-up would be ideal, this study demonstrates a low rate of recurrent prolapse 1 year after the procedure.

How much do laparoscopic, abdominal, and robotic-assisted sacrocolpopexy cost?

Judd JP, Siddiqui NY, Barnett JC, et al. Cost-minimization analysis of robotic-assisted, laparoscopic, and abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2010;17: 493–499.

This cost-minimization analysis concluded that robotic-assisted sacrocolpopexy incurs the highest hospital charges but is reimbursed by Medicare at a rate similar to reimbursement for the abdominal and laparoscopic routes (TABLE 2).

TABLE 2

Cost of sacrocolpopexy is significant—especially using the robotic approach

The analysis accounted for realistic practices, such as the inclusion of concurrent hysterectomy and other procedures.

Details of the trial

Surgeons from Duke University developed a decision-analysis model in which a hypothetical group of women with advanced vaginal prolapse could choose between one of the three routes of sacrocolpopexy: abdominal, laparoscopic, or robotic-assisted. Researchers postulated two different scenarios:

• the hospital had ownership of a robotic system
• the hospital invested in the initial purchase and maintenance of such a system.

Researchers reviewed the literature to formulate their estimates of operative time, rate of conversion to laparotomy, rate of transfusion, and length of hospital stay. In addition, the costs of initial anesthesia setup, professional fees, per-minute intraoperative fees, and postanesthesia care were applied to each approach. Operating room costs per minute and the cost of disposable items such as drapes, gowns, gloves, and single-use instruments were added. For the robotic approach, the costs of reusable instruments were distributed across 10 operations. Reusable instruments for laparoscopic and abdominal surgery were assumed to incur no additional investment. Last, postoperative care—including laboratory tests, pharmacy usage, and the need for a hospital room—were individualized for each route of surgery and applied to the cost.

Costs were estimated in 2008 US dollars, based on procedure costs incurred at Duke University Medical Center.

Physician reimbursement data were obtained from Medicare reimbursement rates for anesthesia and from surgeon Current Procedural Terminology (CPT) codes specific to each procedure.

Quality-of-life assessments were not measured. Nor was the cost to society of the postoperative loss of productivity and wages for each surgical route. Had these losses been recognized, the authors observed, the cost of robotic surgery may have been lower.

The cost of robotic surgery was equivalent to the cost of laparoscopy in only two instances:

• when the operative time of robotic surgery was reduced to 149 minutes
• when the cost of robotic disposable items was less than $2,132 (reduced from a baseline cost of $3,293).

We want to hear from you! Tell us what you think.

When a woman has advanced prolapse of the anterior vaginal wall, it is highly likely that she has apical prolapse as well. Consider a study by Rooney and associates that determined that clinically significant vault prolapse is present in most women who have anterior vaginal prolapse of stage II or higher.¹ For that reason, suspension of the vaginal apex should be considered whenever surgical treatment of anterior wall defects is planned.

Sacrocolpopexy involves suspension of the vaginal vault from the anterior longitudinal ligament of the sacrum, using Y-shaped mesh to augment native tissue (FIGURE).² It is an effective, durable treatment for vaginal apical prolapse. With a success rate approaching 93%, this procedure has become the gold standard for repair of vault prolapse. Among its advantages are maximization of vaginal depth and preservation of a normal vaginal axis.

Sacrocolpopexy preserves the vaginal axis

With the vaginal vault suspended from the anterior longitudinal
ligament of the sacrum, the normal vaginal axis is preserved
and vaginal depth is maximized.

Sacrocolpopexy can be performed via the abdominal, laparoscopic, or robotic-assisted approach (TABLE 1). Minimally invasive techniques are attractive because they involve faster recovery than abdominal sacrocolpopexy does. Minimally invasive techniques have also advanced to the point that they are both effective and durable. However, these advantages must be weighed against the effort required to learn the techniques, as well as their higher cost.

TABLE 1

How the 3 approaches to sacrocolpopexy compare

In this article, we highlight:

• a comparison of the laparoscopic and abdominal approaches to sacrocolpopexy
• an investigation of the learning curve associated with robotic-assisted sacrocolpopexy
• a study exploring the durability of robotic-assisted repair
• an estimate of the costs associated with each route of operation.

Laparoscopic vs abdominal sacrocolpopexy—how do they compare?

Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005;192(5):1752–1758.

When surgeons at the Cleveland Clinic performed a retrospective cohort study to compare laparoscopic and abdominal sacrocolpopexy, they found significantly longer operative time with the laparoscopic route, with an average difference of 51 minutes (P < .0001). However, the laparoscopic approach was associated with lower blood loss (although there was no difference between groups in hematocrit on postoperative day 1); shorter hospital stay (average of 1.8 days versus 4 days [P < .001]); and comparable rates of intraoperative and postoperative complications.

Details of the trial

Paraiso and colleagues reviewed the medical charts of 56 consecutive patients who had undergone laparoscopic sacrocolpopexy, comparing them with the charts of 61 consecutive patients who had undergone the procedure using the abdominal approach. The operations had been performed between 1998 and 2003 for treatment of posthysterectomy vaginal prolapse.

The groups underwent similar rates of concurrent procedures. The laparotomy group had a significantly higher number of Burch procedures (P = .007), and the laparoscopic group had a significantly higher rate of adhesiolysis (P = .002).

Among the complications noted— which occurred at comparable rates between groups—were cystotomy, enterotomy, need for transfusion, deep-vein thrombosis, ileus, small bowel obstruction, wound infection, ventral hernia, mesh erosion, and recurrent prolapse. One laparoscopic case was converted to laparotomy because of excessive bleeding during the rectopexy portion of the operation.

Laparoscopy may have taken longer than this trial suggests

This study is one of very few well-designed trials comparing laparoscopic sacrocolpopexy to the historical gold standard of abdominal sacrocolpopexy for vault prolapse.

Twenty-eight percent of laparoscopic procedures in this study used tacking devices in lieu of suturing. Had suturing been performed universally, an even greater difference in surgical time may have been observed.

There may also be differences between groups in the durability of the two types of repair, an outcome not included in this particular study.

How steep is the learning curve for robotic-assisted sacrocolpopexy?

Akl MN, Long JB, Giles DL, et al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc. 2009;23(10):2390–2394.

Akl and coworkers reviewed the medical records of all patients who had undergone robotic-assisted sacrocolpopexy at the Mayo Clinics in Arizona and Florida between 2004 and 2007. All operations were performed by the same four urogynecologists, with an average operative time of 197.9 minutes (standard deviation, ± 66.8 minutes). However, after the first 10 cases, the operative time decreased by 64.3 minutes—a decline of 25.4% (P < .01; 95% confidence interval [CI], 16.1–112.4 minutes).

Details of the trial

Researchers collected baseline information on participants’ age, stage of prolapse, and concomitant procedures. They also gathered data on average operative time, estimated blood loss, intraoperative and postoperative complications, conversion to laparotomy, and length of hospitalization.

Of 80 women who had advanced pelvic organ prolapse (stage III/IV) who underwent robotic-assisted sacrocolpopexy, 88% underwent concomitant robotic and vaginal procedures, including robotic supracervical hysterectomy, Burch procedure, paravaginal repair, lysis of adhesions, bilateral salpingooophorectomy, vaginal cystocele or rectocele repair, and placement of a midurethral sling.

Estimated blood loss for the robotic-assisted approach ranged from 25 mL to 300 mL, with a mean loss of 96.8 mL. Average length of hospitalization was 2.6 days. Four cases (5%) were converted to laparotomy because of limited exposure and one intraoperative bladder injury. Other intraoperative complications included small-bowel injury during trocar placement and one ureteral injury. Postoperative complications included one case of ileus and five (6%) vaginal mesh erosions. Three patients developed recurrent prolapse and underwent subsequent correction.

Learning curve could have been measured more precisely

The authors did not specifically measure the learning curve for robotic-assisted sacrocolpopexy, as they took into account the concomitant procedures. For this reason, the decrease in operative time observed after 10 cases may not accurately reflect an improvement in the performance of sacrocolpopexy.

Akl and colleagues consider this detail to be a strength of the study because most women who undergo prolapse surgery have concomitant procedures. However, recording the length of time it took to perform the sacrocolpopexy portion of the procedure would have been more accurate.

The average length of stay approached that of the abdominal route. Length of stay may decline as a surgeon gains experience with the robotic-assisted approach.

Does robotic-assisted sacrocolpopexy provide durable support?

Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006;176(2):655–659.

Among the few recent series reporting long-term outcomes after robotic-assisted sacrocolpopexy is this observational study from the Mayo Clinic. It involved 30 women who underwent the operation for the treatment of Baden Walker grade 4/4 posthysterectomy vaginal vault prolapse. The authors concluded that advanced prolapse can be treated with robotic-assisted sacrocolpopexy with long-term success and minimal complications.

Details of the trial

Of 30 women in this trial, 52% underwent an anti-incontinence procedure at the time of sacrocolpopexy. Women who had multiple vaginal defects or a history of abdominal surgery were excluded from the study.

Average operative time was 3.1 hours (range, 2.15–4.75 hours) in the early phase of development of operative technique (described in the manuscript) but diminished over time to an average of 2.5 hours.

Twenty-nine patients were discharged from the hospital after an overnight stay. Very few immediate postoperative complications were observed. Two patients experienced mild port-site infections that required outpatient treatment, and one patient had persistent vaginal bleeding from the incision made during the anti-incontinence procedure.

Most patients were followed for at least 1 year

The mean follow-up in this study was 24 months (range, 16–39 months). During this period, 21 women were followed for a full year. Long-term observation revealed that the repair of vault prolapse remained successful in 19 of these women.

One patient experienced recurrent prolapse 7 months after surgery. Another developed a rectocele 9 months after sacrocolpopexy. Vaginal mesh erosions occurred in two patients within 6 months after the procedure; both patients were treated with outpatient resection of the exposed mesh, with no recurrence of the prolapse.

Although a larger sample size and longer follow-up would be ideal, this study demonstrates a low rate of recurrent prolapse 1 year after the procedure.

How much do laparoscopic, abdominal, and robotic-assisted sacrocolpopexy cost?

Judd JP, Siddiqui NY, Barnett JC, et al. Cost-minimization analysis of robotic-assisted, laparoscopic, and abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2010;17: 493–499.

This cost-minimization analysis concluded that robotic-assisted sacrocolpopexy incurs the highest hospital charges but is reimbursed by Medicare at a rate similar to reimbursement for the abdominal and laparoscopic routes (TABLE 2).

TABLE 2

Cost of sacrocolpopexy is significant—especially using the robotic approach

The analysis accounted for realistic practices, such as the inclusion of concurrent hysterectomy and other procedures.

Details of the trial

Surgeons from Duke University developed a decision-analysis model in which a hypothetical group of women with advanced vaginal prolapse could choose between one of the three routes of sacrocolpopexy: abdominal, laparoscopic, or robotic-assisted. Researchers postulated two different scenarios:

• the hospital had ownership of a robotic system
• the hospital invested in the initial purchase and maintenance of such a system.

Researchers reviewed the literature to formulate their estimates of operative time, rate of conversion to laparotomy, rate of transfusion, and length of hospital stay. In addition, the costs of initial anesthesia setup, professional fees, per-minute intraoperative fees, and postanesthesia care were applied to each approach. Operating room costs per minute and the cost of disposable items such as drapes, gowns, gloves, and single-use instruments were added. For the robotic approach, the costs of reusable instruments were distributed across 10 operations. Reusable instruments for laparoscopic and abdominal surgery were assumed to incur no additional investment. Last, postoperative care—including laboratory tests, pharmacy usage, and the need for a hospital room—were individualized for each route of surgery and applied to the cost.

Costs were estimated in 2008 US dollars, based on procedure costs incurred at Duke University Medical Center.

Physician reimbursement data were obtained from Medicare reimbursement rates for anesthesia and from surgeon Current Procedural Terminology (CPT) codes specific to each procedure.

Quality-of-life assessments were not measured. Nor was the cost to society of the postoperative loss of productivity and wages for each surgical route. Had these losses been recognized, the authors observed, the cost of robotic surgery may have been lower.

The cost of robotic surgery was equivalent to the cost of laparoscopy in only two instances:

• when the operative time of robotic surgery was reduced to 149 minutes
• when the cost of robotic disposable items was less than $2,132 (reduced from a baseline cost of $3,293).

We want to hear from you! Tell us what you think.

When a woman has advanced prolapse of the anterior vaginal wall, it is highly likely that she has apical prolapse as well. Consider a study by Rooney and associates that determined that clinically significant vault prolapse is present in most women who have anterior vaginal prolapse of stage II or higher.¹ For that reason, suspension of the vaginal apex should be considered whenever surgical treatment of anterior wall defects is planned.

Sacrocolpopexy involves suspension of the vaginal vault from the anterior longitudinal ligament of the sacrum, using Y-shaped mesh to augment native tissue (FIGURE).² It is an effective, durable treatment for vaginal apical prolapse. With a success rate approaching 93%, this procedure has become the gold standard for repair of vault prolapse. Among its advantages are maximization of vaginal depth and preservation of a normal vaginal axis.

Sacrocolpopexy preserves the vaginal axis

With the vaginal vault suspended from the anterior longitudinal
ligament of the sacrum, the normal vaginal axis is preserved
and vaginal depth is maximized.

Sacrocolpopexy can be performed via the abdominal, laparoscopic, or robotic-assisted approach (TABLE 1). Minimally invasive techniques are attractive because they involve faster recovery than abdominal sacrocolpopexy does. Minimally invasive techniques have also advanced to the point that they are both effective and durable. However, these advantages must be weighed against the effort required to learn the techniques, as well as their higher cost.

TABLE 1

How the 3 approaches to sacrocolpopexy compare

In this article, we highlight:

• a comparison of the laparoscopic and abdominal approaches to sacrocolpopexy
• an investigation of the learning curve associated with robotic-assisted sacrocolpopexy
• a study exploring the durability of robotic-assisted repair
• an estimate of the costs associated with each route of operation.

Laparoscopic vs abdominal sacrocolpopexy—how do they compare?

Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005;192(5):1752–1758.

When surgeons at the Cleveland Clinic performed a retrospective cohort study to compare laparoscopic and abdominal sacrocolpopexy, they found significantly longer operative time with the laparoscopic route, with an average difference of 51 minutes (P < .0001). However, the laparoscopic approach was associated with lower blood loss (although there was no difference between groups in hematocrit on postoperative day 1); shorter hospital stay (average of 1.8 days versus 4 days [P < .001]); and comparable rates of intraoperative and postoperative complications.

Details of the trial

Paraiso and colleagues reviewed the medical charts of 56 consecutive patients who had undergone laparoscopic sacrocolpopexy, comparing them with the charts of 61 consecutive patients who had undergone the procedure using the abdominal approach. The operations had been performed between 1998 and 2003 for treatment of posthysterectomy vaginal prolapse.

The groups underwent similar rates of concurrent procedures. The laparotomy group had a significantly higher number of Burch procedures (P = .007), and the laparoscopic group had a significantly higher rate of adhesiolysis (P = .002).

Among the complications noted— which occurred at comparable rates between groups—were cystotomy, enterotomy, need for transfusion, deep-vein thrombosis, ileus, small bowel obstruction, wound infection, ventral hernia, mesh erosion, and recurrent prolapse. One laparoscopic case was converted to laparotomy because of excessive bleeding during the rectopexy portion of the operation.

Laparoscopy may have taken longer than this trial suggests

This study is one of very few well-designed trials comparing laparoscopic sacrocolpopexy to the historical gold standard of abdominal sacrocolpopexy for vault prolapse.

Twenty-eight percent of laparoscopic procedures in this study used tacking devices in lieu of suturing. Had suturing been performed universally, an even greater difference in surgical time may have been observed.

There may also be differences between groups in the durability of the two types of repair, an outcome not included in this particular study.

How steep is the learning curve for robotic-assisted sacrocolpopexy?

Akl MN, Long JB, Giles DL, et al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc. 2009;23(10):2390–2394.

Akl and coworkers reviewed the medical records of all patients who had undergone robotic-assisted sacrocolpopexy at the Mayo Clinics in Arizona and Florida between 2004 and 2007. All operations were performed by the same four urogynecologists, with an average operative time of 197.9 minutes (standard deviation, ± 66.8 minutes). However, after the first 10 cases, the operative time decreased by 64.3 minutes—a decline of 25.4% (P < .01; 95% confidence interval [CI], 16.1–112.4 minutes).

Details of the trial

Researchers collected baseline information on participants’ age, stage of prolapse, and concomitant procedures. They also gathered data on average operative time, estimated blood loss, intraoperative and postoperative complications, conversion to laparotomy, and length of hospitalization.

Of 80 women who had advanced pelvic organ prolapse (stage III/IV) who underwent robotic-assisted sacrocolpopexy, 88% underwent concomitant robotic and vaginal procedures, including robotic supracervical hysterectomy, Burch procedure, paravaginal repair, lysis of adhesions, bilateral salpingooophorectomy, vaginal cystocele or rectocele repair, and placement of a midurethral sling.

Estimated blood loss for the robotic-assisted approach ranged from 25 mL to 300 mL, with a mean loss of 96.8 mL. Average length of hospitalization was 2.6 days. Four cases (5%) were converted to laparotomy because of limited exposure and one intraoperative bladder injury. Other intraoperative complications included small-bowel injury during trocar placement and one ureteral injury. Postoperative complications included one case of ileus and five (6%) vaginal mesh erosions. Three patients developed recurrent prolapse and underwent subsequent correction.

Learning curve could have been measured more precisely

The authors did not specifically measure the learning curve for robotic-assisted sacrocolpopexy, as they took into account the concomitant procedures. For this reason, the decrease in operative time observed after 10 cases may not accurately reflect an improvement in the performance of sacrocolpopexy.

Akl and colleagues consider this detail to be a strength of the study because most women who undergo prolapse surgery have concomitant procedures. However, recording the length of time it took to perform the sacrocolpopexy portion of the procedure would have been more accurate.

The average length of stay approached that of the abdominal route. Length of stay may decline as a surgeon gains experience with the robotic-assisted approach.

Does robotic-assisted sacrocolpopexy provide durable support?

Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006;176(2):655–659.

Among the few recent series reporting long-term outcomes after robotic-assisted sacrocolpopexy is this observational study from the Mayo Clinic. It involved 30 women who underwent the operation for the treatment of Baden Walker grade 4/4 posthysterectomy vaginal vault prolapse. The authors concluded that advanced prolapse can be treated with robotic-assisted sacrocolpopexy with long-term success and minimal complications.

Details of the trial

Of 30 women in this trial, 52% underwent an anti-incontinence procedure at the time of sacrocolpopexy. Women who had multiple vaginal defects or a history of abdominal surgery were excluded from the study.

Average operative time was 3.1 hours (range, 2.15–4.75 hours) in the early phase of development of operative technique (described in the manuscript) but diminished over time to an average of 2.5 hours.

Twenty-nine patients were discharged from the hospital after an overnight stay. Very few immediate postoperative complications were observed. Two patients experienced mild port-site infections that required outpatient treatment, and one patient had persistent vaginal bleeding from the incision made during the anti-incontinence procedure.

Most patients were followed for at least 1 year

The mean follow-up in this study was 24 months (range, 16–39 months). During this period, 21 women were followed for a full year. Long-term observation revealed that the repair of vault prolapse remained successful in 19 of these women.

One patient experienced recurrent prolapse 7 months after surgery. Another developed a rectocele 9 months after sacrocolpopexy. Vaginal mesh erosions occurred in two patients within 6 months after the procedure; both patients were treated with outpatient resection of the exposed mesh, with no recurrence of the prolapse.

Although a larger sample size and longer follow-up would be ideal, this study demonstrates a low rate of recurrent prolapse 1 year after the procedure.

How much do laparoscopic, abdominal, and robotic-assisted sacrocolpopexy cost?

Judd JP, Siddiqui NY, Barnett JC, et al. Cost-minimization analysis of robotic-assisted, laparoscopic, and abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2010;17: 493–499.

This cost-minimization analysis concluded that robotic-assisted sacrocolpopexy incurs the highest hospital charges but is reimbursed by Medicare at a rate similar to reimbursement for the abdominal and laparoscopic routes (TABLE 2).

TABLE 2

Cost of sacrocolpopexy is significant—especially using the robotic approach

The analysis accounted for realistic practices, such as the inclusion of concurrent hysterectomy and other procedures.

Details of the trial

Surgeons from Duke University developed a decision-analysis model in which a hypothetical group of women with advanced vaginal prolapse could choose between one of the three routes of sacrocolpopexy: abdominal, laparoscopic, or robotic-assisted. Researchers postulated two different scenarios:

• the hospital had ownership of a robotic system
• the hospital invested in the initial purchase and maintenance of such a system.

Researchers reviewed the literature to formulate their estimates of operative time, rate of conversion to laparotomy, rate of transfusion, and length of hospital stay. In addition, the costs of initial anesthesia setup, professional fees, per-minute intraoperative fees, and postanesthesia care were applied to each approach. Operating room costs per minute and the cost of disposable items such as drapes, gowns, gloves, and single-use instruments were added. For the robotic approach, the costs of reusable instruments were distributed across 10 operations. Reusable instruments for laparoscopic and abdominal surgery were assumed to incur no additional investment. Last, postoperative care—including laboratory tests, pharmacy usage, and the need for a hospital room—were individualized for each route of surgery and applied to the cost.

Costs were estimated in 2008 US dollars, based on procedure costs incurred at Duke University Medical Center.

Physician reimbursement data were obtained from Medicare reimbursement rates for anesthesia and from surgeon Current Procedural Terminology (CPT) codes specific to each procedure.

Quality-of-life assessments were not measured. Nor was the cost to society of the postoperative loss of productivity and wages for each surgical route. Had these losses been recognized, the authors observed, the cost of robotic surgery may have been lower.

The cost of robotic surgery was equivalent to the cost of laparoscopy in only two instances:

• when the operative time of robotic surgery was reduced to 149 minutes
• when the cost of robotic disposable items was less than $2,132 (reduced from a baseline cost of $3,293).

We want to hear from you! Tell us what you think.

Because we will all be seeing more patients with stress urinary incontinence and other urogynecologic issues, it is critical that we keep abreast of the treatment options available—and their relative effectiveness.¹

In this exploration of nonsurgical approaches to stress incontinence, Richter and colleagues started with the premise that a combination of instructed pelvic floor exercises and an incontinence pessary would be better than either treatment alone. They (very appropriately) designated the following as primary outcome measures:

• patient-reported improvement
• symptoms of stress incontinence
• patient satisfaction, as measured using validated instruments.

As reported above, combination therapy did not prove to be superior to single-modality intervention. And although behavioral therapy was superior to a pessary at 3 months, by 12 months the modalities were roughly equivalent, and only about half of patients were still using the prescribed therapy: pessary (45%) or pelvic floor exercises (57%).

This is not a real-world study

Most women who have stress incontinence and who select nonsurgical therapy choose only one option—pelvic floor exercises (if very motivated), a vaginal pessary or other device (if not so motivated), or another conservative option such as radiofrequency therapy (if even less motivated). In this study, women enrolled in behavioral therapy paid four visits (at roughly 2-week intervals) to approved “interventionists,” who instructed them in the technique for pelvic floor exercise and explained other skills and strategies to prevent urge and stress incontinence.

Many women find it difficult to attend the four to eight physiotherapy sessions that are necessary for behavioral intervention and are unwilling to devote 1 year to a therapy that they don’t find effective early on. (Physiotherapy is effective but requires a motivated patient.) Other women dislike inserting a vaginal device on a regular basis. ²

What’s more, very safe minimally invasive slings are available that offer more definitive therapy to patients who have stress incontinence. That said, a sling procedure should not be undertaken lightly. Patient selection should be based on preoperative testing, including an assessment of urethral function, for the transobturator sling.³ A retropubic sling requires a greater degree of expertise to tension appropriately but is suitable for a wider range of severity, including intrinsic sphincteric deficiency. The role of single-incision slings is unclear.

Bottom line: individualize care

The authors’ concluding statements are right on the money: “Individualization of care should continue to be the cornerstone of our approach to [stress incontinent] patients.” These women have several effective options available. We should help them make an educated choice based on symptom severity, lifestyle, and willingness to enroll in self-help intervention versus surgical therapy.

Because we will all be seeing more patients with stress urinary incontinence and other urogynecologic issues, it is critical that we keep abreast of the treatment options available—and their relative effectiveness.¹

In this exploration of nonsurgical approaches to stress incontinence, Richter and colleagues started with the premise that a combination of instructed pelvic floor exercises and an incontinence pessary would be better than either treatment alone. They (very appropriately) designated the following as primary outcome measures:

• patient-reported improvement
• symptoms of stress incontinence
• patient satisfaction, as measured using validated instruments.

As reported above, combination therapy did not prove to be superior to single-modality intervention. And although behavioral therapy was superior to a pessary at 3 months, by 12 months the modalities were roughly equivalent, and only about half of patients were still using the prescribed therapy: pessary (45%) or pelvic floor exercises (57%).

This is not a real-world study

Most women who have stress incontinence and who select nonsurgical therapy choose only one option—pelvic floor exercises (if very motivated), a vaginal pessary or other device (if not so motivated), or another conservative option such as radiofrequency therapy (if even less motivated). In this study, women enrolled in behavioral therapy paid four visits (at roughly 2-week intervals) to approved “interventionists,” who instructed them in the technique for pelvic floor exercise and explained other skills and strategies to prevent urge and stress incontinence.

Many women find it difficult to attend the four to eight physiotherapy sessions that are necessary for behavioral intervention and are unwilling to devote 1 year to a therapy that they don’t find effective early on. (Physiotherapy is effective but requires a motivated patient.) Other women dislike inserting a vaginal device on a regular basis. ²

What’s more, very safe minimally invasive slings are available that offer more definitive therapy to patients who have stress incontinence. That said, a sling procedure should not be undertaken lightly. Patient selection should be based on preoperative testing, including an assessment of urethral function, for the transobturator sling.³ A retropubic sling requires a greater degree of expertise to tension appropriately but is suitable for a wider range of severity, including intrinsic sphincteric deficiency. The role of single-incision slings is unclear.

Bottom line: individualize care

The authors’ concluding statements are right on the money: “Individualization of care should continue to be the cornerstone of our approach to [stress incontinent] patients.” These women have several effective options available. We should help them make an educated choice based on symptom severity, lifestyle, and willingness to enroll in self-help intervention versus surgical therapy.

Because we will all be seeing more patients with stress urinary incontinence and other urogynecologic issues, it is critical that we keep abreast of the treatment options available—and their relative effectiveness.¹

In this exploration of nonsurgical approaches to stress incontinence, Richter and colleagues started with the premise that a combination of instructed pelvic floor exercises and an incontinence pessary would be better than either treatment alone. They (very appropriately) designated the following as primary outcome measures:

• patient-reported improvement
• symptoms of stress incontinence
• patient satisfaction, as measured using validated instruments.

As reported above, combination therapy did not prove to be superior to single-modality intervention. And although behavioral therapy was superior to a pessary at 3 months, by 12 months the modalities were roughly equivalent, and only about half of patients were still using the prescribed therapy: pessary (45%) or pelvic floor exercises (57%).

This is not a real-world study

Most women who have stress incontinence and who select nonsurgical therapy choose only one option—pelvic floor exercises (if very motivated), a vaginal pessary or other device (if not so motivated), or another conservative option such as radiofrequency therapy (if even less motivated). In this study, women enrolled in behavioral therapy paid four visits (at roughly 2-week intervals) to approved “interventionists,” who instructed them in the technique for pelvic floor exercise and explained other skills and strategies to prevent urge and stress incontinence.

Many women find it difficult to attend the four to eight physiotherapy sessions that are necessary for behavioral intervention and are unwilling to devote 1 year to a therapy that they don’t find effective early on. (Physiotherapy is effective but requires a motivated patient.) Other women dislike inserting a vaginal device on a regular basis. ²

What’s more, very safe minimally invasive slings are available that offer more definitive therapy to patients who have stress incontinence. That said, a sling procedure should not be undertaken lightly. Patient selection should be based on preoperative testing, including an assessment of urethral function, for the transobturator sling.³ A retropubic sling requires a greater degree of expertise to tension appropriately but is suitable for a wider range of severity, including intrinsic sphincteric deficiency. The role of single-incision slings is unclear.

Bottom line: individualize care

The authors’ concluding statements are right on the money: “Individualization of care should continue to be the cornerstone of our approach to [stress incontinent] patients.” These women have several effective options available. We should help them make an educated choice based on symptom severity, lifestyle, and willingness to enroll in self-help intervention versus surgical therapy.

The authors report no financial relationships relevant to this article.

Overactive bladder (OAB)—urinary urgency, with or without incontinence, usually with frequency and nocturia¹—is a common problem among women who seek care from an ObGyn. In fact, the condition is estimated to carry a health-care cost in excess of $12 billion annually in the United States.²

A recent community-based survey in Norway estimated the prevalence of urinary incontinence there to be 27% in women between the ages of 65 and 69 years and 35% to 40% in those 80 years or older.³ A population-based study in the United States suggested an even higher rate of urinary incontinence here: greater than 50% in women 60 years or older, with 1) urge urinary incontinence (UUI) predominating⁴ and 2) the prevalence particularly high among older women who are homebound or who live in a long-term care facility.⁵

OAB can undermine quality of life in several ways: social isolation, anxiety, poor sleep, higher risk of fracture after a fall,⁶ reduced ability to function, and poor self-perception. Despite these harmful effects, many women delay seeking care for OAB because they are embarrassed to talk about it with their physician.

Treatment by generalists is feasible—but there is a catch

It’s possible to treat most patients with OAB without referral to a specialist. Two common concerns, however, may set up a roadblock to successful management: the adverse effects associated with some agents and suboptimal control of symptoms.

In this Update, we review recent findings about 1) the potential that anticholinergic therapy has for impairing cognitive function in the older population of women and 2) the important role that concomitant behavioral therapy plays in the long-term success of, and patients’ satisfaction with, treatment of OAB.

Behavioral therapy for OAB: Is it worth all the effort?

Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc. 2000;48:370–374.

The authors of this article followed a randomized clinical trial of older women that compared behavioral and drug therapy for OAB. In the trial, biofeedback-assisted behavioral training (comprising anorectal biofeedback, urge strategies, pelvic muscle biofeedback, and practitioner-directed review with optimization) was compared with treatment with oxybutynin, between 2.5 and 15 mg/day. Both biofeedback-assisted behavioral therapy and the drug regimen were found effective, although neither treatment provided an entirely satisfactory result for all patients. (For a brief description of what constitutes behavioral treatment, see “6 tenets of behavioral therapy for urge urinary incontinence.”)

Second phase of the trial. To determine if treatment satisfaction could be enhanced, the investigators performed a modified crossover study to determine whether combination therapy—biofeedback-assisted behavioral training plus oxybutynin—added any benefit over treatment with behavioral therapy or drug therapy alone. Eligibility was determined by age (55 years or older), demonstrated UUI for at least 3 months, and incomplete dryness or incomplete satisfaction with the outcome of 8 weeks of single-intervention treatment (with either treatment) during the initial phase of the trial.

This subgroup was offered an additional 8 weeks of combination therapy. The primary outcome measure was a reduction in the frequency of episodes of incontinence episodes as recorded by subjects in a bladder diary.

Of 197 women who participated in the original randomized clinical trial, 35—27 who completed drug therapy and 8 who completed behavioral treatment—elected to receive combination therapy. Those 35 subjects did not differ in any of the multiple baseline variables; mean age was 69.3 years (standard deviation [SD], ±7.9 years).

Among subjects originally assigned to behavioral therapy alone, overall reduction in incontinence increased from a mean of 57.5% to a mean of 88.5% after combined therapy (P=.034). Subjects originally assigned to drug therapy alone demonstrated an improvement from 72.7% reduction in incontinence to a mean 84.3% overall reduction with combined therapy (P=.001).

These data suggest that combined therapy can be more effective than behavioral therapy or drug therapy alone. The impact of this study is limited, however, by the relatively low percentage (12.7%) of patients who had received behavioral therapy and chose to add drug therapy, compared with the 41.5% who moved from drug therapy alone to add behavioral therapy.

Furthermore, subjects were self-selected: They chose to continue with an additional 8 weeks of therapy after their initial suboptimal outcome. It is possible that some subjects who were neither totally continent nor completely satisfied with initial therapy chose not to continue with the crossover segment of the trial because it posed too great a burden or because they were discouraged with the initial degree of improvement.

Generalizing these results to all older women with UUI is difficult. The authors point out, however, that, in practice, patients may be more likely than not to choose combination therapy in the hope of shortening the duration of medical therapy. Although it isn’t known whether providing combination therapy from the outset would have yielded better outcomes than either single therapy did, the authors hypothesize that initial combination therapy may result in greater improvement because patients have a high level of motivation and expectation of improvement at the beginning of treatment.

Importance of this article. The investigators demonstrated that a combination of behavioral and drug therapies can provide increased effectiveness in patients for whom each treatment alone led to suboptimal satisfaction. Furthermore, by targeting women older than 55 years, the investigators were able to demonstrate this effectiveness in a group for whom pelvic-floor training may be more difficult than it is for younger women.

It will be interesting to see if future research will 1) validate these findings and 2) determine whether combined therapy can reduce the duration of drug therapy in this older population through behavioral modification and pelvic floor reeducation.

Does oxybutynin for UUI further erode cognition in elderly women who are cognitively impaired?

Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C. Randomized, placebo-controlled trial of the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired nursing home residents with urge urinary incontinence. J Am Geriatr Soc. 2008;56:862–870.

Although anticholinergic therapy is modestly effective against UUI in nursing home residents, past studies have suggested that such treatment can impair, or further impair, cognition in this population—a concern that may lead to underuse. This double-blinded, randomized, placebo-controlled trial compared short-term oral extended-release oxybutynin with placebo.

Consequently, the authors sought to determine the cognitive effect, safety, and tolerability of 5 mg/day oral extended-release oxybutynin (the most commonly prescribed dosage) in cognitively impaired older nursing home residents who have UUI.

Subjects were eligible if they:

• were 65 years or older
• had UUI
• lived in a nursing home longer than 3 months
• had cognitive impairment.

Women already being treated for urinary incontinence, those who had an indwelling Foley catheter or urinary retention, and those who were bed-bound or incommunicative were excluded.

Fifty women, mean age 88.6 years (SD, ±6.2), from 12 nursing home facilities, agreed to participate. They were further stratified based on the score of a Mini-Mental State Exam (MMSE): 13 had severe cognitive impairment (MMSE score, 5–10) and 37 had mild or moderate impairment (score, 11–23).

Subjects were randomized to 4 weeks’ treatment with either 5 mg/day oral extended-release oxybutynin or one placebo tablet daily. A nurse practitioner who was blinded to randomization collected all data. The Confusion Assessment Method (CAM) algorithm, MMSE, and Severe Impairment Battery (SIB) were used to assess cognitive decline. The Brief Agitation Rating Scale (BARS) assessed agitation.

No baseline differences were noted with regard to: age; demographic, functional, and neuropsychiatric characteristics; clinical factors predisposing to delirium; and serum anticholinergic activity. Adherence was similar in the treatment (97%) and placebo (97.4%) groups.

Finding: Cognitive impairment. Treatment and placebo groups in the baseline mild-or-moderate stratum (by MMSE) showed equivalent mean changes in CAM scores at all time points. Because of the small sample size, however, CAM score equivalence could not be definitively determined for the groups in the severe impairment stratum. Evaluation of mean MMSE and BARS scores showed no significant changes between groups.

Finding: Tolerability. Excellent tolerability was noted in the treatment group: 96% of subjects completed the trial (compared with 92% of the placebo group). No difference in the rate of adverse events was noted between treatment and placebo groups; of adverse events recorded, 90% were judged “mild” by the investigators. Constipation and dry mouth were most common.

Finding: Falls. More than half—54%—of subjects in both groups experienced at least one fall during the trial or during the preceding or following 3 months. Despite this, no difference in the rate of falls between the treatment and placebo groups was noted. Furthermore, regression analysis revealed no treatment or period effect on falls per month across the time of observation.

Conclusions. Treatment with 5 mg/day oral extended-release oxybutynin in older patients with some cognitive impairment is well tolerated, the study’s findings suggest, with minimal risk of further cognitive decline or delirium over the short term. The potential that long-term therapy has to harm cognitive function remains, however; data on long-term treatment are needed to illuminate that area.

The authors also address the importance of dosing, especially over time, and discuss the lower potential of newer-generation anticholinergics to produce cognitive impairment.

A limited number of articles in the medical literature address anticholinergics in an older population, specifically, and only a few of those evaluated the effects of the drugs on cognitive function. By investigating patients who had an existing cognitive impairment, the authors of this article were able to target a cohort at risk of further cognitive impairment from medication use—thereby giving further weight to their findings of no significant effect.

Main strengths and limitations of the study. The investigators used validated, standardized cognitive tests that were administered by a uniform blinded evaluator in a randomized, controlled trial. The study was limited, however, because patients were evaluated only over a relatively short period (1 month) and because the efficacy of therapy was not addressed.

Further studies of anticholinergic medications, using the same rigorous scientific approach that these investigators applied, are needed to address 1) the long-term efficacy of oxybutynin and similar agents and 2) the cognitive effects of long-term treatment in this older population.

The authors report no financial relationships relevant to this article.

Overactive bladder (OAB)—urinary urgency, with or without incontinence, usually with frequency and nocturia¹—is a common problem among women who seek care from an ObGyn. In fact, the condition is estimated to carry a health-care cost in excess of $12 billion annually in the United States.²

A recent community-based survey in Norway estimated the prevalence of urinary incontinence there to be 27% in women between the ages of 65 and 69 years and 35% to 40% in those 80 years or older.³ A population-based study in the United States suggested an even higher rate of urinary incontinence here: greater than 50% in women 60 years or older, with 1) urge urinary incontinence (UUI) predominating⁴ and 2) the prevalence particularly high among older women who are homebound or who live in a long-term care facility.⁵

OAB can undermine quality of life in several ways: social isolation, anxiety, poor sleep, higher risk of fracture after a fall,⁶ reduced ability to function, and poor self-perception. Despite these harmful effects, many women delay seeking care for OAB because they are embarrassed to talk about it with their physician.

Treatment by generalists is feasible—but there is a catch

It’s possible to treat most patients with OAB without referral to a specialist. Two common concerns, however, may set up a roadblock to successful management: the adverse effects associated with some agents and suboptimal control of symptoms.

In this Update, we review recent findings about 1) the potential that anticholinergic therapy has for impairing cognitive function in the older population of women and 2) the important role that concomitant behavioral therapy plays in the long-term success of, and patients’ satisfaction with, treatment of OAB.

Behavioral therapy for OAB: Is it worth all the effort?

Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc. 2000;48:370–374.

The authors of this article followed a randomized clinical trial of older women that compared behavioral and drug therapy for OAB. In the trial, biofeedback-assisted behavioral training (comprising anorectal biofeedback, urge strategies, pelvic muscle biofeedback, and practitioner-directed review with optimization) was compared with treatment with oxybutynin, between 2.5 and 15 mg/day. Both biofeedback-assisted behavioral therapy and the drug regimen were found effective, although neither treatment provided an entirely satisfactory result for all patients. (For a brief description of what constitutes behavioral treatment, see “6 tenets of behavioral therapy for urge urinary incontinence.”)

Second phase of the trial. To determine if treatment satisfaction could be enhanced, the investigators performed a modified crossover study to determine whether combination therapy—biofeedback-assisted behavioral training plus oxybutynin—added any benefit over treatment with behavioral therapy or drug therapy alone. Eligibility was determined by age (55 years or older), demonstrated UUI for at least 3 months, and incomplete dryness or incomplete satisfaction with the outcome of 8 weeks of single-intervention treatment (with either treatment) during the initial phase of the trial.

This subgroup was offered an additional 8 weeks of combination therapy. The primary outcome measure was a reduction in the frequency of episodes of incontinence episodes as recorded by subjects in a bladder diary.

Of 197 women who participated in the original randomized clinical trial, 35—27 who completed drug therapy and 8 who completed behavioral treatment—elected to receive combination therapy. Those 35 subjects did not differ in any of the multiple baseline variables; mean age was 69.3 years (standard deviation [SD], ±7.9 years).

Among subjects originally assigned to behavioral therapy alone, overall reduction in incontinence increased from a mean of 57.5% to a mean of 88.5% after combined therapy (P=.034). Subjects originally assigned to drug therapy alone demonstrated an improvement from 72.7% reduction in incontinence to a mean 84.3% overall reduction with combined therapy (P=.001).

These data suggest that combined therapy can be more effective than behavioral therapy or drug therapy alone. The impact of this study is limited, however, by the relatively low percentage (12.7%) of patients who had received behavioral therapy and chose to add drug therapy, compared with the 41.5% who moved from drug therapy alone to add behavioral therapy.

Furthermore, subjects were self-selected: They chose to continue with an additional 8 weeks of therapy after their initial suboptimal outcome. It is possible that some subjects who were neither totally continent nor completely satisfied with initial therapy chose not to continue with the crossover segment of the trial because it posed too great a burden or because they were discouraged with the initial degree of improvement.

Generalizing these results to all older women with UUI is difficult. The authors point out, however, that, in practice, patients may be more likely than not to choose combination therapy in the hope of shortening the duration of medical therapy. Although it isn’t known whether providing combination therapy from the outset would have yielded better outcomes than either single therapy did, the authors hypothesize that initial combination therapy may result in greater improvement because patients have a high level of motivation and expectation of improvement at the beginning of treatment.

Importance of this article. The investigators demonstrated that a combination of behavioral and drug therapies can provide increased effectiveness in patients for whom each treatment alone led to suboptimal satisfaction. Furthermore, by targeting women older than 55 years, the investigators were able to demonstrate this effectiveness in a group for whom pelvic-floor training may be more difficult than it is for younger women.

It will be interesting to see if future research will 1) validate these findings and 2) determine whether combined therapy can reduce the duration of drug therapy in this older population through behavioral modification and pelvic floor reeducation.

Does oxybutynin for UUI further erode cognition in elderly women who are cognitively impaired?

Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C. Randomized, placebo-controlled trial of the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired nursing home residents with urge urinary incontinence. J Am Geriatr Soc. 2008;56:862–870.

Although anticholinergic therapy is modestly effective against UUI in nursing home residents, past studies have suggested that such treatment can impair, or further impair, cognition in this population—a concern that may lead to underuse. This double-blinded, randomized, placebo-controlled trial compared short-term oral extended-release oxybutynin with placebo.

Consequently, the authors sought to determine the cognitive effect, safety, and tolerability of 5 mg/day oral extended-release oxybutynin (the most commonly prescribed dosage) in cognitively impaired older nursing home residents who have UUI.

Subjects were eligible if they:

• were 65 years or older
• had UUI
• lived in a nursing home longer than 3 months
• had cognitive impairment.

Women already being treated for urinary incontinence, those who had an indwelling Foley catheter or urinary retention, and those who were bed-bound or incommunicative were excluded.

Fifty women, mean age 88.6 years (SD, ±6.2), from 12 nursing home facilities, agreed to participate. They were further stratified based on the score of a Mini-Mental State Exam (MMSE): 13 had severe cognitive impairment (MMSE score, 5–10) and 37 had mild or moderate impairment (score, 11–23).

Subjects were randomized to 4 weeks’ treatment with either 5 mg/day oral extended-release oxybutynin or one placebo tablet daily. A nurse practitioner who was blinded to randomization collected all data. The Confusion Assessment Method (CAM) algorithm, MMSE, and Severe Impairment Battery (SIB) were used to assess cognitive decline. The Brief Agitation Rating Scale (BARS) assessed agitation.

No baseline differences were noted with regard to: age; demographic, functional, and neuropsychiatric characteristics; clinical factors predisposing to delirium; and serum anticholinergic activity. Adherence was similar in the treatment (97%) and placebo (97.4%) groups.

Finding: Cognitive impairment. Treatment and placebo groups in the baseline mild-or-moderate stratum (by MMSE) showed equivalent mean changes in CAM scores at all time points. Because of the small sample size, however, CAM score equivalence could not be definitively determined for the groups in the severe impairment stratum. Evaluation of mean MMSE and BARS scores showed no significant changes between groups.

Finding: Tolerability. Excellent tolerability was noted in the treatment group: 96% of subjects completed the trial (compared with 92% of the placebo group). No difference in the rate of adverse events was noted between treatment and placebo groups; of adverse events recorded, 90% were judged “mild” by the investigators. Constipation and dry mouth were most common.

Finding: Falls. More than half—54%—of subjects in both groups experienced at least one fall during the trial or during the preceding or following 3 months. Despite this, no difference in the rate of falls between the treatment and placebo groups was noted. Furthermore, regression analysis revealed no treatment or period effect on falls per month across the time of observation.

Conclusions. Treatment with 5 mg/day oral extended-release oxybutynin in older patients with some cognitive impairment is well tolerated, the study’s findings suggest, with minimal risk of further cognitive decline or delirium over the short term. The potential that long-term therapy has to harm cognitive function remains, however; data on long-term treatment are needed to illuminate that area.

The authors also address the importance of dosing, especially over time, and discuss the lower potential of newer-generation anticholinergics to produce cognitive impairment.

A limited number of articles in the medical literature address anticholinergics in an older population, specifically, and only a few of those evaluated the effects of the drugs on cognitive function. By investigating patients who had an existing cognitive impairment, the authors of this article were able to target a cohort at risk of further cognitive impairment from medication use—thereby giving further weight to their findings of no significant effect.

Main strengths and limitations of the study. The investigators used validated, standardized cognitive tests that were administered by a uniform blinded evaluator in a randomized, controlled trial. The study was limited, however, because patients were evaluated only over a relatively short period (1 month) and because the efficacy of therapy was not addressed.

Further studies of anticholinergic medications, using the same rigorous scientific approach that these investigators applied, are needed to address 1) the long-term efficacy of oxybutynin and similar agents and 2) the cognitive effects of long-term treatment in this older population.

The authors report no financial relationships relevant to this article.

Overactive bladder (OAB)—urinary urgency, with or without incontinence, usually with frequency and nocturia¹—is a common problem among women who seek care from an ObGyn. In fact, the condition is estimated to carry a health-care cost in excess of $12 billion annually in the United States.²

A recent community-based survey in Norway estimated the prevalence of urinary incontinence there to be 27% in women between the ages of 65 and 69 years and 35% to 40% in those 80 years or older.³ A population-based study in the United States suggested an even higher rate of urinary incontinence here: greater than 50% in women 60 years or older, with 1) urge urinary incontinence (UUI) predominating⁴ and 2) the prevalence particularly high among older women who are homebound or who live in a long-term care facility.⁵

OAB can undermine quality of life in several ways: social isolation, anxiety, poor sleep, higher risk of fracture after a fall,⁶ reduced ability to function, and poor self-perception. Despite these harmful effects, many women delay seeking care for OAB because they are embarrassed to talk about it with their physician.

Treatment by generalists is feasible—but there is a catch

It’s possible to treat most patients with OAB without referral to a specialist. Two common concerns, however, may set up a roadblock to successful management: the adverse effects associated with some agents and suboptimal control of symptoms.

In this Update, we review recent findings about 1) the potential that anticholinergic therapy has for impairing cognitive function in the older population of women and 2) the important role that concomitant behavioral therapy plays in the long-term success of, and patients’ satisfaction with, treatment of OAB.

Behavioral therapy for OAB: Is it worth all the effort?

Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc. 2000;48:370–374.

The authors of this article followed a randomized clinical trial of older women that compared behavioral and drug therapy for OAB. In the trial, biofeedback-assisted behavioral training (comprising anorectal biofeedback, urge strategies, pelvic muscle biofeedback, and practitioner-directed review with optimization) was compared with treatment with oxybutynin, between 2.5 and 15 mg/day. Both biofeedback-assisted behavioral therapy and the drug regimen were found effective, although neither treatment provided an entirely satisfactory result for all patients. (For a brief description of what constitutes behavioral treatment, see “6 tenets of behavioral therapy for urge urinary incontinence.”)

Second phase of the trial. To determine if treatment satisfaction could be enhanced, the investigators performed a modified crossover study to determine whether combination therapy—biofeedback-assisted behavioral training plus oxybutynin—added any benefit over treatment with behavioral therapy or drug therapy alone. Eligibility was determined by age (55 years or older), demonstrated UUI for at least 3 months, and incomplete dryness or incomplete satisfaction with the outcome of 8 weeks of single-intervention treatment (with either treatment) during the initial phase of the trial.

This subgroup was offered an additional 8 weeks of combination therapy. The primary outcome measure was a reduction in the frequency of episodes of incontinence episodes as recorded by subjects in a bladder diary.

Of 197 women who participated in the original randomized clinical trial, 35—27 who completed drug therapy and 8 who completed behavioral treatment—elected to receive combination therapy. Those 35 subjects did not differ in any of the multiple baseline variables; mean age was 69.3 years (standard deviation [SD], ±7.9 years).

Among subjects originally assigned to behavioral therapy alone, overall reduction in incontinence increased from a mean of 57.5% to a mean of 88.5% after combined therapy (P=.034). Subjects originally assigned to drug therapy alone demonstrated an improvement from 72.7% reduction in incontinence to a mean 84.3% overall reduction with combined therapy (P=.001).

These data suggest that combined therapy can be more effective than behavioral therapy or drug therapy alone. The impact of this study is limited, however, by the relatively low percentage (12.7%) of patients who had received behavioral therapy and chose to add drug therapy, compared with the 41.5% who moved from drug therapy alone to add behavioral therapy.

Furthermore, subjects were self-selected: They chose to continue with an additional 8 weeks of therapy after their initial suboptimal outcome. It is possible that some subjects who were neither totally continent nor completely satisfied with initial therapy chose not to continue with the crossover segment of the trial because it posed too great a burden or because they were discouraged with the initial degree of improvement.

Generalizing these results to all older women with UUI is difficult. The authors point out, however, that, in practice, patients may be more likely than not to choose combination therapy in the hope of shortening the duration of medical therapy. Although it isn’t known whether providing combination therapy from the outset would have yielded better outcomes than either single therapy did, the authors hypothesize that initial combination therapy may result in greater improvement because patients have a high level of motivation and expectation of improvement at the beginning of treatment.

Importance of this article. The investigators demonstrated that a combination of behavioral and drug therapies can provide increased effectiveness in patients for whom each treatment alone led to suboptimal satisfaction. Furthermore, by targeting women older than 55 years, the investigators were able to demonstrate this effectiveness in a group for whom pelvic-floor training may be more difficult than it is for younger women.

It will be interesting to see if future research will 1) validate these findings and 2) determine whether combined therapy can reduce the duration of drug therapy in this older population through behavioral modification and pelvic floor reeducation.

Does oxybutynin for UUI further erode cognition in elderly women who are cognitively impaired?

Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C. Randomized, placebo-controlled trial of the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired nursing home residents with urge urinary incontinence. J Am Geriatr Soc. 2008;56:862–870.

Although anticholinergic therapy is modestly effective against UUI in nursing home residents, past studies have suggested that such treatment can impair, or further impair, cognition in this population—a concern that may lead to underuse. This double-blinded, randomized, placebo-controlled trial compared short-term oral extended-release oxybutynin with placebo.

Consequently, the authors sought to determine the cognitive effect, safety, and tolerability of 5 mg/day oral extended-release oxybutynin (the most commonly prescribed dosage) in cognitively impaired older nursing home residents who have UUI.

Subjects were eligible if they:

• were 65 years or older
• had UUI
• lived in a nursing home longer than 3 months
• had cognitive impairment.

Women already being treated for urinary incontinence, those who had an indwelling Foley catheter or urinary retention, and those who were bed-bound or incommunicative were excluded.

Fifty women, mean age 88.6 years (SD, ±6.2), from 12 nursing home facilities, agreed to participate. They were further stratified based on the score of a Mini-Mental State Exam (MMSE): 13 had severe cognitive impairment (MMSE score, 5–10) and 37 had mild or moderate impairment (score, 11–23).

Subjects were randomized to 4 weeks’ treatment with either 5 mg/day oral extended-release oxybutynin or one placebo tablet daily. A nurse practitioner who was blinded to randomization collected all data. The Confusion Assessment Method (CAM) algorithm, MMSE, and Severe Impairment Battery (SIB) were used to assess cognitive decline. The Brief Agitation Rating Scale (BARS) assessed agitation.

No baseline differences were noted with regard to: age; demographic, functional, and neuropsychiatric characteristics; clinical factors predisposing to delirium; and serum anticholinergic activity. Adherence was similar in the treatment (97%) and placebo (97.4%) groups.

Finding: Cognitive impairment. Treatment and placebo groups in the baseline mild-or-moderate stratum (by MMSE) showed equivalent mean changes in CAM scores at all time points. Because of the small sample size, however, CAM score equivalence could not be definitively determined for the groups in the severe impairment stratum. Evaluation of mean MMSE and BARS scores showed no significant changes between groups.

Finding: Tolerability. Excellent tolerability was noted in the treatment group: 96% of subjects completed the trial (compared with 92% of the placebo group). No difference in the rate of adverse events was noted between treatment and placebo groups; of adverse events recorded, 90% were judged “mild” by the investigators. Constipation and dry mouth were most common.

Finding: Falls. More than half—54%—of subjects in both groups experienced at least one fall during the trial or during the preceding or following 3 months. Despite this, no difference in the rate of falls between the treatment and placebo groups was noted. Furthermore, regression analysis revealed no treatment or period effect on falls per month across the time of observation.

Conclusions. Treatment with 5 mg/day oral extended-release oxybutynin in older patients with some cognitive impairment is well tolerated, the study’s findings suggest, with minimal risk of further cognitive decline or delirium over the short term. The potential that long-term therapy has to harm cognitive function remains, however; data on long-term treatment are needed to illuminate that area.

The authors also address the importance of dosing, especially over time, and discuss the lower potential of newer-generation anticholinergics to produce cognitive impairment.

A limited number of articles in the medical literature address anticholinergics in an older population, specifically, and only a few of those evaluated the effects of the drugs on cognitive function. By investigating patients who had an existing cognitive impairment, the authors of this article were able to target a cohort at risk of further cognitive impairment from medication use—thereby giving further weight to their findings of no significant effect.

Main strengths and limitations of the study. The investigators used validated, standardized cognitive tests that were administered by a uniform blinded evaluator in a randomized, controlled trial. The study was limited, however, because patients were evaluated only over a relatively short period (1 month) and because the efficacy of therapy was not addressed.

Further studies of anticholinergic medications, using the same rigorous scientific approach that these investigators applied, are needed to address 1) the long-term efficacy of oxybutynin and similar agents and 2) the cognitive effects of long-term treatment in this older population.