Stress urinary incontinence (SUI) is an involuntary loss of urine on effort, physical exertion, or with an increase in the intraabdominal pressure upon sneezing or coughing ( ). Pelvic organ prolapse (POP) is clinically defined as “the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or cuff scar after hysterectomy)” ( ). Nonsurgical management of SUI and POP should be offered to all patients. Most women are not aware of the existence of nonsurgical treatments for incontinence and prolapse, and they are often relieved that treatment options other than surgery are available. Behavioral treatment, the current “gold standard” conservative approach for SUI, improves bladder control by changing the incontinent patient’s behavior, including learning skills for preventing urine loss. Multicomponent behavioral interventions include pelvic floor muscle training (PFMT) and exercise, stress and urgency suppression strategies, and biofeedback. As part of the first-line treatment, estrogen optimizes urogenital tissue health and relieves some lower urinary tract symptoms, a common genitourinary syndrome of menopause ( ; ). Although no US Food and Drug Administration (FDA)-approved medications exist for the treatment of SUI, certain medications, including duloxetine, may offer effective treatment for mild to moderate stress incontinence. Pessaries stabilize the proximal urethra, and urethral inserts (no longer available) acted by increasing urethral pressure. Pessaries also provide support for symptomatic POP. Such devices provide valuable alternatives to surgery.
This chapter describes the full range of nonsurgical options for the treatment of SUI and POP, allowing us to offer a broad spectrum of less invasive treatment options in an individualized manner. Optimal behavioral therapy for urinary incontinence depends on several factors, including the type and severity of incontinence; the presence of associated conditions, such as prolapse or other pelvic pathology; prior surgical or nonsurgical therapy; the patient’s medical status; and the patient’s ability and willingness to actively participate in and adhere to treatment. Similarly, nonsurgical therapy for prolapse may be used in women with significant medical comorbidities that preclude them from having surgery, those who do not wish to undergo surgical therapy, or those who want a temporizing measure before surgical intervention. Evidence-based approaches exist for the full spectrum of conservative therapy for the management of SUI and POP.
The bladder diary: A valuable clinical tool
Before initiating nonsurgical treatment for incontinence, it is advisable to have the patient complete a bladder diary for 3 to 7 days. At a minimum, the patient should record the time and circumstances of each incontinence episode. The bladder diary assists the clinician in determining the type and severity of urine loss and in planning appropriate intervention. If the woman has associated urgency urinary incontinence (UUI) and overactive bladder symptoms of urgency and frequency, the type and amount of fluid intake, the frequency of urination, and the urgency associated with each can also be recorded ( ) This information can identify women who may benefit from more frequent urination to avoid a full bladder, especially during physical activity. It may also reveal cases in which voiding frequency is excessive and may be contributing to reduced bladder capacity and urgency. Using the diary, the circumstances of incontinence can be reviewed with the patient, and instructions can be given that are specific to the patient’s situation. During treatment, the number of incontinent episodes can be monitored to determine the efficacy of treatment and to guide further intervention. Although more burdensome, it is also suggested that women record voided volumes for a 24-hour period by completing a frequency-volume bladder diary ( Fig. 14.1 ). This record can identify patients with abnormal urine production, especially those with increased nighttime urine production resulting in nocturia.
In addition to the value of the bladder diary to the clinician, completing a daily diary appears to benefit the patient directly. As a form of self-monitoring, it enhances the patient’s awareness of her voiding habits and incontinence patterns, and it facilitates her recognition of the relationship between her activities and incontinence. Specifically, understanding clearly the precipitants of urine leakage optimizes the patient’s readiness to implement the continence skills she learns through behavioral treatment.
Behavioral intervention: Pelvic floor muscle training and exercise
PFMT and exercise are the foundation of behavioral treatment for SUI and may be beneficial for the treatment and prevention of POP ( ). A Cochrane review of PFMT-based treatments concluded that these treatments were effective for both SUI and mixed urinary incontinence ( ) and can reduce urgency, but women with pure SUI may have better outcomes ( ). Gynecologist Arnold Kegel first popularized PFMT in the late 1940s. He asserted that women with SUI lack awareness and coordination of the pelvic floor muscles (PFMs) and that SUI could be resolved with PFMT ( ; ). Through the years, this intervention has evolved both as a behavioral therapy and a physical therapy, combining principles from both fields into a widely accepted conservative treatment for SUI and UUI.
Literature on outpatient behavioral treatment with PFMT and exercise has demonstrated that it is effective for reducing SUI, UUI, and mixed incontinence in most patients who cooperate with training. Behavioral treatments have been recognized for their efficacy by multiple organizations and panels, including the International Consultation on Incontinence and the American Urological Association Guideline on Overactive Bladder ( ; ; ). Although the majority of women are not cured with this approach, most can achieve significant improvement.
Teaching pelvic floor muscle control
The goal of behavioral interventions for SUI is to teach patients how to improve urethral closure by contracting PFMs during physical activities that cause urine leakage, such as coughing, sneezing, or lifting. In patients who have a combination of SUI and UUI, quick PFM contractions are performed to lessen urgency sensations before voiding. The premise is that a deliberate PFM contraction will prevent urine loss, increasing intraurethral pressure by raising the urethra and pressing it toward the symphysis pubis, preventing urethral descent, limiting its downward movement during increases in abdominal pressure, and improving structural support of the pelvic organs ( ). PFMT may result in hypertrophy of the striated PFM, thus increasing the external mechanical pressure on the urethra. Intensive PFMT is also hypothesized to reinforce structural support of the bladder neck in women ( ; ). Using biofeedback or other teaching methods, patients are taught to identify the PFMs and to isolate, contract, and relax them selectively (without increasing intraabdominal pressure).
Many women fail PFM exercise by religiously exercising the wrong muscles. Helping women identify and isolate the correct muscles is an essential yet often overlooked step. The most common approach to PFMT is to give women a pamphlet or brief verbal instructions to “lift the pelvic floor” or to interrupt the urinary stream during voiding. This approach is generally ineffective, most likely because most women do not properly identify the PFMs or do not persist long enough to reap the benefits of behavioral treatment. It is more effective to begin treatment by ensuring that the patient understands which muscles to use. This understanding is often accomplished by palpating the vagina during pelvic examination and guiding her with verbal feedback to find the proper muscles. The levator ani can be palpated just proximal to the hymeneal ring ( Fig. 14.2 ), at the 4 and 8 o’clock positions, to determine strength and to determine whether palpation reproduces any discomfort or tenderness ( ).
Biofeedback is not a treatment in itself but a teaching technique that helps patients learn by giving them immediate feedback on their bladder or pelvic muscle activity. introduced a biofeedback device he called the perineometer, consisting of a pneumatic chamber that was placed in the vagina and a handheld pressure gauge that registered increased vaginal pressure generated by pelvic muscle contraction ( Fig. 14.3 ). This device provided immediate visual feedback to the woman learning to identify her PFMs and monitoring her practice.
Current biofeedback instruments are computerized. Pelvic muscle activity can be measured using vaginal or anal manometry (pressure measurement) or surface electrode electromyography (most common), with a probe or perianal surface skin electrodes. Signals are augmented through a computer, and muscle activity is displayed on a monitor where patients can receive immediate visual or auditory feedback. Patients learn better control through operant conditioning (learning by trial and error) by observing the results of their attempts to control bladder and PFM responses ( Fig. 14.4 ). Biofeedback-assisted behavioral training has been tested in several studies, producing mean reductions of incontinence ranging from 60% to 85% ( ). Patients can usually identify their PFMs in a single session; treatment may require less repetition of biofeedback than was originally thought.
The most common problem in identifying the PFMs is that women tend to contract other muscles, typically the rectus abdominis or gluteal muscles, instead of or in conjunction with PFM. Contracting abdominal muscles is counterproductive because it increases pressure on the bladder rather than the urethra. Women commonly will perform a straining Valsalva maneuver or fail to activate all layers of the pelvic musculature. Thus, it is important to notice these incorrect responses and to teach the patient to relax other muscle groups when contracting the PFMs. To avoid bearing down, the clinician should instruct the woman to not hold her breath or to count out loud during the muscle contraction. Coordinated training of transversus abdominis muscles has also been recommended by some clinicians, because it is believed that these muscles facilitate PFM contraction. However, in a systematic review of the literature, noted an absence of evidence for this type of training, and it remains controversial.
Daily exercise to improve strength and control
Once patients learn to properly contract and relax the pelvic muscles selectively, a program of daily exercise is prescribed. The purpose of the daily regimen is not only to increase muscle strength, but also to enhance the skill of using the muscles through practice. The optimal exercise regimen has yet to be determined; however, good results are generally achieved by performing 45 to 50 exercises per day. To avoid muscle fatigue, the exercises should be spaced across the day, usually in two to three sessions ( Box 14.1 ). Patients generally find it easiest to practice their exercises in the lying position at first. But they should be encouraged to practice in the sitting or standing positions as well, so they become comfortable using their muscles to avoid SUI, which primarily occurs in the standing position.
Programs should be individualized ( ; ; ), but one approach is to recommend a series of “quick flicks” or 1- to 2-second contractions, followed by sustained contractions (endurance contractions) of 5 seconds, building to 10 seconds. The patient is encouraged to aim for a high level of concentrated effort with each PFM contraction, as greater contraction intensity is associated with improvement in PFM strength. Each muscle contraction is followed by a period of relaxation using a 1:1 or 1:2 ratio, allowing the muscles to recover between contractions.
Using PFMs to prevent stress incontinence: Stress strategies
Although exercise alone can improve urethral support and continence status, optimal results depend on patients learning to use their muscles actively to prevent urine loss during physical exertion. With practice and encouragement, patients can develop the habit of consciously contracting the PFMs to occlude the urethra before and during coughing, sneezing, or any other physical activities that have precipitated urine leakage. This skill has been referred to as the “stress strategy” ( ) and the “Knack maneuver” ( ; ). demonstrated immediate reduction in the volume of urine leakage with a cough when anticipatory PFM contraction was used. Some women will benefit simply from learning how to control their PFMs and use them to prevent incontinence episodes ( ). Others will need a more comprehensive program of PFM rehabilitation to increase strength and skill.
Using PFMs to prevent urgency incontinence: Urgency suppression strategies
Traditionally, PFMT and exercise were used almost exclusively for SUI. However, voluntary PFM contractions can also inhibit a detrusor contraction, and this skill is a part of a behavioral treatment involving an urgency suppression strategy for patients with urgency, frequency, and/or UUI. Patients are taught a new way to respond to the sensation of urgency: instead of rushing to the toilet, which increases intraabdominal pressure and exposes patients to visual cues that can trigger incontinence, patients are encouraged to pause, sit down if possible, relax the entire body, and contract the PFM repeatedly to diminish urgency, inhibit detrusor contraction, and prevent urine loss. When urgency subsides, they are to proceed to the toilet at a normal pace.
Behavioral training for UUI has been tested in several clinical series using pre-post designs and also in randomized trials. In controlled trials using intention-to-treat models, the mean reduction of incontinence episodes ranges from 60% to 80% ( ; ).
Pelvic floor muscle training and exercise for pelvic organ prolapse
PFMT has been used for the treatment of POP. By improving PFM strength, it is thought that training can lead to improved structural support for pelvic organs. In addition, active contraction of PFMs can be taught to brace against increases in intraabdominal pressure and thus protect the pelvic floor during coughing, sneezing, or any activity that increases pressure on the pelvic floor.
There is a small amount of literature on the effectiveness of PFMT for POP, including five randomized trials comparing training with no treatment ( ; ; ; ; ). The evidence indicates that training has a beneficial effect on PFM function, prolapse symptom burden, prolapse severity, and quality of life ( ).
Adherence and maintenance
PFMT and exercise require the active participation of a motivated patient ( ). It is often challenging to remember to use the PFMs strategically in daily life and to persist in a regular exercise regimen to maintain strength and skill. This reliance on patient behavior change represents the major limitation of this treatment approach. In addition, improvement with behavioral treatment is gradual, usually evident by the fourth week of training and continuing for up to 6 months. Herein lies the challenge for behavioral treatment: sustaining the patient’s motivation for long enough that she will experience noticeable change in her bladder control.
It is important in initiating behavioral treatment to communicate realistic expectations and make it clear to the patient that it may take weeks to months for symptom improvement, and that the improvement may be irregular, with “good” days and “bad” days. Success with symptom improvement will depend on consistent practice and use of her new skills. The patient who understands the usual course of treatment will be better prepared to persist until results are achieved. Clinicians can provide support by scheduling follow-up appointments to track and reinforce patient progress, make adjustments to the exercise regimen, and encourage persistence.
Measurement of adherence to PFM exercise and behavioral strategies is poor ( ; ). There is very little research on methods to identify barriers and improve adherence ( ; ; ; ). reported on adherence to PFM exercise and bladder control strategies as a secondary analysis of a multisite randomized controlled trial comparing three interventions for stress-predominant UI: intravaginal continence pessary, multicomponent behavioral therapy (including PFMT and bladder control strategies), and pessary and behavioral therapy combined ( ). The authors concluded that adherence to PFM exercises and bladder control strategies, when implemented by trained interventionists, can be high and sustained over time.
Pelvic floor electrical stimulation has been used for the treatment of urinary incontinence since 1952 ( ). In this original study, electrical stimulation was added to PFM exercises to treat SUI in women who had failed treatment with exercise alone; seven of 17 women were cured. Fifteen years later, pelvic floor electrical stimulation was reported by using a vaginal probe, and thereafter this treatment was more widely used.
Pelvic floor electrical stimulation stimulates pudendal nerve afferents, activating pudendal and hypogastric nerve efferents, causing contraction of smooth and striated periurethral and pelvic muscles. This stimulation provides a form of passive exercise, with the goal of improving the urethral closure mechanism. In addition, electrical stimulation can be useful in teaching PFM contraction to women who cannot identify or contract these muscles voluntarily. Stimulation can be applied using surface electrodes, delivering transcutaneous electrical stimulation via suprapubic, sacral, or external anal skin surface electrodes or intravaginal or intrarectal sensors for 15 minutes at a time, one to three times per day. An alternative, noninvasive approach that may be easier and less embarrassing for women is to administer electrical stimulation via surface skin electrodes on a garment that holds the electrodes around the pelvic area to ensure satisfactory recruitment of the PFM ( ). The literature on pelvic floor electrical stimulation in women indicates that it is effective for improving SUI ( ) and urgency and mixed urinary incontinence compared to sham or no treatment ( ).
Weighted vaginal cones
Weighted vaginal cones provide a progressive muscular load during the performance of PFMT. A systematic review was performed of 23 small trials involving 1806 women, of whom 717 received cones ( ). The overall quality of the trials was not optimal. Use of cones was found to be better than no active treatment, but there was inconclusive evidence for a subjective cure between cones and PFMT. It has been recommended that, for motivated women with SUI, vaginal cones with supervised training sessions can be a first-line therapy ( ).
Weight loss and urinary incontinence
Epidemiologic research has established obesity as a strong, independent risk factor for prevalent and incident incontinence, including both SUI and UUI ( ; ; ; ; ; ). There is a clear dose-response effect: each 5-unit increase in body mass index is associated with a 20% to 70% increase in the risk of prevalent incontinence and a 30% to 60% increase in the odds of 5- to 10-year incident incontinence. Furthermore, intervention studies show that weight loss has a beneficial effect on incontinence ( ; ). Urinary symptoms significantly improve in morbidly obese women with dramatic weight loss (45–50 kg) after bariatric surgery ( ; ; ) and when women lose as little as 5% of their baseline weight with behavioral weight loss programs ( ; ), a reasonable goal for many overweight or obese women. Pooled data from a recent meta-analysis and systematic review on the effect of bariatric surgery on urinary incontinence in obese women revealed that bariatric surgery significantly reduced the incidence of urinary incontinence at 6 and 12 months and improved pelvic floor symptoms as measured by the Pelvic Floor Distress Inventory-20 ( ).
Lifestyle interventions, specifically weight loss, have demonstrated credible efficacy in the reduction of SUI symptoms. In a randomized controlled trial (RCT) in which overweight and obese women with incontinence were given a self-administered behavioral program and randomized to a 6-month behavioral weight loss program or control intervention, the weight loss group showed a 47% reduction in frequency of incontinence, significantly greater than the 28% shown by the control group ( ). Group differences were significant for stress incontinence and total incontinence after 12 months and for urgency incontinence after 18 months ( ). The weight loss group also had greater patient satisfaction ratings at 6, 12, and 18 months. Because modest weight loss is achievable for many women, it should be considered in the first-line behavioral treatment of women with stress, urgency, or mixed urinary incontinence. In general, significant weight loss (15–20 body mass index units) decreases urinary incontinence, and moderate weight loss is effective if combined with PFM exercises ( ).
Complementary and alternative therapies for urinary incontinence
According to the viewpoint of traditional Chinese medicine, acupuncture could impact SUI symptoms by reinforcing “qi,” the vital substance constituting the human body, and promote bladder function recovery, presumably via the autonomic nervous system ( ). The only Cochrane review on this subject ( ) reviewed 17 studies, but only one small trial of acupuncture versus medication met the inclusion criteria. A greater number of women in the acupuncture group improved compared with midodrine (73% vs. 33%, respectively); however, cure rates were low and did not differ between groups (13% vs. 7%). More robust research is needed in this area of treatment.
Yoga, a system of philosophy, lifestyle, and physical practice, originated in India and has been used in managing several medical conditions, including musculoskeletal disorders, cardiovascular disorders, stress, depression, and anxiety ( ). Only two studies of yoga for the treatment of SUI, with a total of 49 subjects, were included in a recent systematic review ( ), and the quality of the data was lacking. In general, yoga participants sustained benefit, but there is insufficient evidence to prescribe yoga as a standard-of-care nonsurgical therapy for SUI.
Estrogen and stress urinary incontinence
Estrogen is discussed separately from other pharmacologic therapies for SUI because it should be a generalized recommendation for many women for optimized urogenital tissue health. The prevalence of symptomatic urogenital atrophy in postreproductive women may approach 50%, and, because the lower urinary tract and vagina develop from the same embryologic origin, it is not surprising that estrogen receptors are present throughout the vagina, urethra, bladder trigone, pelvic connective tissue, and pelvic muscles. Decreased estrogen effect and the resulting urogenital atrophy, now commonly referred to as genitourinary syndrome of menopause, produce symptoms of vaginal and vulvar dryness, pruritus, dyspareunia, and vaginitis, recurrent urinary tract infections and lower urinary tract symptoms such as dysuria, urinary frequency, urinary urgency, nocturia and incontinence. Painful urination or “urethral syndrome” secondary to decreased estrogen effect responds to local estrogen therapy, as do nocturia, irritative bladder symptoms, and recurrent urinary tract infections. As the use of oral estrogen has been noted to worsen urinary incontinence symptoms ( ), this current discussion will focus on the use of intravaginal estrogen.
Estrogen exerts beneficial effects in the urethra by increasing the concentration of α-adrenergic receptors in the urethra and bladder, improving vascularity and perfusion of the periurethral tissue, and increasing thickness of the urethral epithelium. These changes facilitate coaptation and increase urethral pressure ( ). A Cochrane review assessed the effect of systemic and intravaginal estrogenin women symptomatic for or with a urodynamic diagnosis of stress, urgency, or mixed urinary incontinence ( ). There was evidence that intravaginal estrogen may improve incontinence (relative risk [RR], 0.74; 95% confidence interval (CI), 0.64-0.86), but little long-term data exist. Further, there was noted improvement in voiding frequency and urinary urgency. Subsequent systematic reviews noted that, compared with placebo, vaginal estrogens improved vaginal dryness, dyspareunia, urinary urgency, frequency, SUI, and UUI. Urinary tract infection rates were also diminished ( ; ).
Urogenital atrophy is an FDA-approved indication for estrogen therapy. Lower urinary tract symptoms associated with atrophy also significantly improve with intravaginal estrogen therapy. Therefore we strongly recommend optimizing urogenital tissue health as first-line treatment with intravaginal estrogen therapy, before or concurrently with behavioral therapy, pessary use, or any other nonsurgical treatment, and before surgical intervention for SUI. When the uterus is present, progestin treatment may be considered on an individual basis, although, when used as directed, serum estrogen levels do not rise above postmenopausal levels ( ). We typically recommend approximately 0.5 g of vaginal estrogen cream nightly for 2 weeks, with maintenance doses of 0.5 g two to three times per week thereafter. Estrogen rings and tablets have standardized recommended regimens ( Table 14.1 ).
|Estradiol cream||0.1 mg/g||Allergan, Inc., Madison, NJ|
|Estrace vaginal cream|
|Conjugated estrogens cream||0.625 mg/g||Pfizer Pharmaceuticals Inc., New York, NY|
|Premarin vaginal cream|
|Estradiol vaginal ring||2 mg/3 months||Pfizer Pharmaceuticals Inc., New York, NY; Millicent Pharma, Inc., Dunkalk, Ireland|
|Estradiol vaginal tablets||10 μg/tablet||Novo Nordisk Health Care AG, Inc., Plainsboro, NJ|
Other pharmacologic therapies for stress urinary incontinence
Numerous medications have been used to treat SUI ( ); however, none have level 1 data showing robust benefit above placebo or have FDA approval for this primary indication ( Table 14.2 ). Pharmacotherapy for SUI takes advantage of the effects of certain medications on increasing urethral outlet resistance that is mediated by sympathetic, parasympathetic, and somatic innervation coordinated by the central nervous system. Increased outlet resistance may occur in theory with α-adrenergic agonists, β-adrenergic antagonists and agonists, tricyclic antidepressants, and serotonergic and noradrenergic reuptake inhibitors ( ; ).
|Drug Type||Drug Name||Dosage|
|Serotonin/norepinephrine reuptake inhibitor||Duloxetine||40 mg bid|
|α-Adrenergic agonist||Midodrine||2.5 mg tid|
|Pseudoephedrine hydrochloride||15 mg bid, 30 mg bid, tid, qid|
|β-Agonist/antagonist||Clenbuterol||0.02 mg bid|
|Propanolol||10 mg bid to 40 mg tid|
|Tricyclic antidepressant||Imipramine hydrochloride||10 mg qhs (older patients)|
|25 mg tid, 75 mg bid|
α- and β-adrenergic agonists
In a Cochrane review analyzing data from 1099 women, 673 of whom received an adrenergic medication (phenylpropanolamine, 11 trials; midodrine, two trials; norepinephrine, three trials; clenbuterol, three trials, terbutaline, one trial; eskornade, one trial; and Ro 115-1240, one trial), there was limited evidence of adrenergic agonist efficacy over placebo for incontinence episodes ( ). Potential side effects of all α-adrenergic medications include hypertension, anxiety, hemorrhagic stroke, cardiac arrhythmias, palpitations, tremor, weakness, insomnia, and headache. These results were confirmed in another systematic review ( ).
β-adrenergic receptor antagonists
β-adrenergic blocking agents should theoretically potentiate the activity of norepinephrine on α-receptors and increase urethral outlet resistance. Early studies demonstrated efficacy with propranolol in patients with SUI; however, subsequent RCTs have not been as successful. At this time, the role of β-adrenergic receptor antagonists in treating SUI is limited. Significant potential side effects include heart failure, lethargy, and pulmonary compromise.
Tricyclic antidepressants, in particular doxepin and imipramine hydrochloride, improve SUI symptoms by decreasing bladder contractility and increasing urethral resistance. It is thought that they exert central and peripheral anticholinergic effects at some sites. They block the active transport system in the presynaptic nerve ending responsible for the reuptake of norepinephrine and serotonin. They act as sedatives, presumably centrally, but potentially related to antihistaminic properties. No placebo-controlled trials of the effects of tricyclic antidepressants on SUI exist ( ; ). A recent double-blind, randomized, placebo-controlled crossover trial in 16 healthy women showed no difference in the increase in opening urethral pressure between those receiving imipramine and those receiving placebo; there were 13 adverse events related to imipramine in seven subjects. Based on these data, the authors did not recommend off-label use of imipramine for the treatment of SUI ( ). Side effects associated with tricyclic antidepressants include dry mouth, blurred vision, urinary retention, constipation, orthostatic hypotension, sedation, tremors, sexual side effects, fatigue, rash, jaundice, and weakness. Older patients in particular are prone to side effects such as disorientation, falls, heart rhythm abnormalities, and decreased force of cardiac contraction. Lower doses should be used in older patients; we typically start with a 5- to 10-mg nightly dose to determine tolerance and titrate up from there ( Table 14.2 ).
Serotonergic and noradrenergic reuptake inhibitors suppress parasympathetic activity and enhance sympathetic and somatic activity in the lower urinary tract, promoting urine storage. The dual serotonin-norepinephrine reuptake inhibitor duloxetine has shown clinical efficacy for SUI compared with placebo in 10 trials including 3944 subjects randomized to duloxetine or placebo, PFMT, or both ( ). The maximum duration of treatment was 12 weeks. Efficacy of treatment was significantly better with duloxetine versus placebo with respect to quality of life and perception of improvement. Individual studies demonstrated a significant reduction of incontinence episode frequency by 50% with duloxetine (RR 1.56, 95% CI 1.46–1.66) and global improvement (RR 1.24, 95% CI 1.14–1.36) ( ). However, meta-analysis of the stress pad test and the 24-hour pad test showed no difference between duloxetine and placebo. Subjective cure favored duloxetine. Although duloxetine does not have FDA approval for the treatment of SUI in the United States, there has been regulatory approval for this indication in the European Union since 2004. Side effects associated with duloxetine include nausea, fatigue, dry mouth, and insomnia. Nausea was the most common reason for discontinuation in the clinical trials.
A urethral insert acts as a mechanical barrier to prevent urinary leakage by sealing the urethral lumen. Usually these devices have a means to prevent intravesical migration (a tab at the meatus), a mechanism to maintain the device in its proper place at the bladder neck (e.g., balloon, fins), and a device or mechanism to permit removal for voiding (e.g., string, pump) ( ). The intraurethral prosthesis with valves device is for chronic use and is not addressed here. Other inserts (e.g., FemSoft, Rochester Medical, Stewartville, MN) are no longer available. In a Cochrane systematic review addressing the use of mechanical devices for urinary incontinence in women ( ), data obtained from three small, randomized trials studying intraurethral inserts reflected insufficient evidence, both objectively and subjectively, for recommending their use.
Urethral occlusive devices
From a historical perspective, numerous external occlusive devices existed that essentially blocked urine loss through the external urethral meatus. Issues of cost, comfort, patient acceptability of manipulating their genitalia to apply the device, and concerns of lifelong dependence were at the forefront of deciding whether to use these products. There were several reusable external urethral occlusive devices for SUI, and none are currently on the market.
The ins and outs of pessary use
Historically, the use of pessaries has been reserved for those patients who decline surgery for SUI or POP or for those who are not surgical candidates because of significant medical comorbidities. Some practitioners extend indications for pessary use to pregnancy-related prolapse and prolapse and incontinence in older women. However, current US and Canadian practice guidelines suggest that all women interested in prolapse or SUI treatment should be offered a pessary as an alternative to surgical therapy ( ; ). Two studies by showed that age greater than 65 years, severe comorbidity, and maintenance of urinary continence were significant predictors of continued pessary use after 1 year for women with POP, but high-quality evidence remains limited regarding the choice of pessary and management of pessary use. A recent survey of nurse providers (323 respondents) in the United States showed a range of responses in terms of pessary care. Physicians and advanced practice registered nurses (e.g., nurse practitioners) provided up to 80% of the care, and 86% of care occurred in the office setting. Care routines varied, most often including 3-month interval follow-up with speculum vaginal examinations, and no routine use of vaginal products. On-the-job mentoring was the primary knowledge source. This study noted a need for evidence-based guidelines for optimal care, based on patient outcomes, satisfaction, and costs of care ( ). Even urogynecologists have not come to consensus regarding indications for pessaries and their management ( ). Although clinicians have in the past had to rely on descriptive studies, manufacturers’ recommendations, and clinical experience when managing patients who elect pessary treatment, level I evidence supporting pessary use as an alternative treatment to surgery for SUI and prolapse is slowly increasing.
Efficacy of pessaries and vaginal devices for stress urinary incontinence
Pessaries effectively manage SUI in some women during exercise and in daily life. Continence pessaries are placed transvaginally and are designed to prevent urine loss by stabilizing and supporting the urethra and bladder neck, increasing urethra length, and providing gentle compression of the urethra against the pubic bone during increases in intraabdominal pressure. This structural arrangement can reduce and often prevent stress-related incontinence ( ). Most outcomes have been short-term, and most study sizes have been small ( Table 14.3 ). The Ambulatory Treatments for Leakage Associated with Stress trial, a robust level I study performed by the Pelvic Floor Disorders Network, consisted of three treatment arms: behavioral therapy alone (including PFMT), pessary alone, and combined behavioral therapy and pessary ( ). The primary outcomes were treatment efficacy using the Urogenital Distress Inventory stress incontinence subscale of the Pelvic Floor Distress Inventory and the Patient Global Impression of Improvement. Secondary outcomes included the proportion of patients with a 75% reduction of incontinence episodes on 7-day bladder diary and patient satisfaction.