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Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. (Comparative Effectiveness Reviews, No. 36.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness

Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness [Internet].

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Introduction

Urinary incontinence (UI) is the involuntary loss of urine.1 UI affects a significant number of women in the United States and other countries.1 About 25 percent of young women,2 44 to 57 percent of middle-aged and post-menopausal women,3,4 and about 75 percent of older women experience some involuntary urine loss.5 The impact of UI can be serious, affecting women’s physical, psychological, and social wellbeing, and sometimes imposing significant lifestyle restrictions. The effects of UI on an individual may range from slightly bothersome to debilitating.

The cost of UI care in the United States averaged $19.5 billion in 2004.6 Six percent of nursing home admissions of older women is attributable to UI6 and, by one estimate, the annualized cost of nursing home admissions of elderly women due to UI was $3 billion.7,8

Voluntary voiding requires a balance between sphincter activity and bladder function. UI in women is related to actions of the bladder and the urinary sphincter. Stress incontinence is a sphincter failure attributed to intra-abdominal pressure. Urgency incontinence is attributable to sphincter failure with or without overactive bladder contractions. Conversely, an inactive bladder may result in overflow incontinence, whereby urine is retained until bladder capacity is exceeded. In many women, stress and urgency occur together in what is called mixed incontinence. Sphincter failure in women is often associated with weakness of the pelvic floor muscles.

The etiology of incontinence is multifactorial. Known risk factors include age, pregnancy, pelvic floor trauma after vaginal delivery, menopause, hysterectomy, obesity, urinary tract infections, functional and/or cognitive impairment, chronic cough, and constipation.9 Assessments of women complaining of UI begin with exclusion of underlying causes such as pelvic organ prolapse, urinary tract infection, and poor bladder emptying,1 all of which are conditions beyond the scope of this review. We focus specifically on women with stress UI associated with sphincter function, and with urgency UI, often associated with overactive bladder.

Incontinence types are distinguished by their baseline mechanisms. Stress incontinence is associated with sphincter function, and results in an inability to retain urine when coughing or sneezing.10 Urgency incontinence is defined as involuntary loss of urine associated with the sensation of a sudden, compelling urge to void that is difficult to defer.10 Mixed UI is the term applied when both stress and urgency UI are present. These definitions reflect the consensus definitions developed by the International Urogynecological Association (IUGA)/International Continence Society (ICS)10 (Table 1).

Table 1. Definitions of urinary incontinence (UI) and treatment outcomes.

Table 1

Definitions of urinary incontinence (UI) and treatment outcomes.

Overactive bladder is defined as urinary urgency with or without incontinence, usually accompanied by frequency and nocturia (the need to urinate at night).10 Approximately one-third of women with overactive bladder also experience urgency UI. Other diagnoses for female pelvic floor dysfunction beyond the scope of our review include poor bladder emptying, voiding dysfunction, pelvic organ prolapse, and recurrent urinary tract infections, as well as neurogenic UI associated with spinal cord injury or stroke.10

Stress incontinence was the most prevalent type in women 19 to 44 years of age (31 percent)1124 and in those 45 to 64 years of age (33 percent).3,11,13,14,16,18,19,21,2449 The prevalence of urgency UI gradually increased from 13 percent in younger women1119,2124,50 to 17 percent in women 45 to 64 years of age11,13,14,2535 and to 25 percent in women older than 65.13,14,18,19,21,23,24,27,30,34,5168 Older women suffer from both types, and so-called mixed UI; 33 percent of older women13,14,18,19,24,30,52,54,5660,62,63,6668 reported mixed UI.13,30,56

The types of UI imply different attendant risk factors and recommended treatments; however, UI etiology is frequently mixed. Stress UI is associated with pelvic floor trauma and uterine prolapse (both of which are conditions associated with vaginal delivery that often require surgical treatments).9 Urgency and mixed UI are associated with overactive bladder with or without sphincter dysfunction and may benefit from nonsurgical treatments, including pharmacological and nonpharmacological options.1,9

Although diagnosis of UI can be made based on patients’ reports of involuntary urine leakage,9 researchers have also proposed instrumental methods for objective diagnosis of different types of UI. Urodynamic evaluation may help to distinguish pure stress UI without urgency UI for women undergoing surgery for stress UI.10 Diagnostic studies use multichannel urodynamics as a reference standard test to compare with noninvasive tests. However, researchers disagree over whether urodynamic examination represents the gold standard for UI diagnosis.6971 Previously published systematic reviews reported a weak association between urodynamic results and self-reported symptoms;72,73 however, previous reviews did not focus on the most appropriate methods to distinguish different types of UI in ambulatory care clinical settings.7477 The role of invasive diagnostic methods in better predicting treatment outcomes for UI remains unclear.

Our report also addresses the role of urodynamic testing, which is not typically performed in primary care. We include it here primarily as background information for primary care practitioners and because it raises a conundrum. As we have emphasized, the primary outcome for UI should be patient-centered reports of the UI experience, especially the presence or absence of UI. Although we typically think of physiological testing as more objective than patient reports, these results are, at best, akin to intermediate outcomes. In the diagnostic context, physiological testing can inform in one of three ways: (1) establishing a diagnosis; (2) determining an etiology with therapeutic implications; and (3) generating a prognosis. In the case of UI, it is unclear whether physiological measures represent a gold standard against which other measures can be compared or whether they should be viewed as information that may predict key patient-centered outcomes. Hence, we may be more interested in levels of agreement between physiological measures and patient outcomes but hard pressed to interpret differences between them. We examine the role of urodynamic testing in diagnosing and treating UI to provide insight into this conundrum.

Measuring Outcomes of UI Treatment

The variations in definitions of UI complicate evaluation of treatment success. Standard UI treatment for women includes lifestyle changes, pelvic floor muscle training (PFMT), and surgical treatments for stress UI.1 In addition, several drugs have been approved for adults with overactive bladder with or without urgency UI.1 Clinical interventions to reduce the frequency of UI episodes in women have been extensively reviewed in recent years,69,78107 but reviews have not emphasized outcomes of continence or womens’ perceptions of treatment success and satisfaction. However, continence has been considered a primary goal in UI treatment.69,108 Continence is also the most important outcome associated with quality of life in women with UI,109111 but it is rarely examined as a primary outcome in syntheses of evidence.112 Thus, we focus on continence and quality of life as primary outcomes for this comparative effectiveness review.112

While continence is similarly defined across studies, the definitions most often applied to improvement of UI vary and include different degrees of change in frequency and severity of symptoms.113 The Food and Drug Administration (FDA) clinical reviews defined treatment success as a significant reduction in daily UI episodes.112,114,115 An average effect was a significant reduction by two UI episodes per day.112 Clinical importance of this reduction was not clear. Women with severe UI may not even notice this reduction, let alone judge it as a treatment success. Other studies and reviews defined treatment success differently. In addition to varied definitions across studies, improvement in UI has been judged by researchers and women very differently. Researchers have defined improvement as a decrease in the amount of lost urine during pad tests or any statistically significant decrease in the frequency of UI episodes,113 whereas women have defined improvement according to reduced restrictions in lifestyle or improved overall perception of bladder symptoms, especially resolution of urine leakage. Measurement of treatment outcomes should be patient-centered and based on factors important to women, rather than on the results of invasive tests.108 Thus, treatment success and failure should be evaluated according to what women report in validated questionnaires or scales. However, meaningful differences in questionnaires or scales have not been systematically reviewed. Ultimately, discussions of UI are complicated by the wide variety of measures used to describe the problem and its treatment outcomes. We focus on continence as the primary outcome for this comparative effectiveness review.69,108

Clinical interventions to reduce the progression of UI have been extensively reviewed during recent years by the Agency for Healthcare Research and Quality (AHRQ),79,80 the Cochrane Collaborative Group,8188,90107,116,117 the International Consultation on Incontinence (ICI),69,78 and the National Institute for Health and Clinical Excellence.118 However, the comparative effectiveness of different UI treatments, including pharmacological therapies and their effects on patient morbidity119 and quality of life,120 were beyond the scope of previously published evidence-based reports.121 In addition, previously published reports did not include pharmacological treatments for urgency UI.9,81 Systemic estrogens have been associated with increased risk of UI.9 Selective estrogen receptor modulators did not demonstrate consistent benefits for UI prevention.122,123 Based on discussions with key informants and Technical Expert Panel members, we excluded systemic estrogen treatments from our review.

Pharmacological agents to treat urgency UI act as muscarinic antagonists.124126 The drugs bind to muscarinic receptors but do not activate them, thereby blocking the actions of acetylcholine, the endogenous neurostimulator of urinary bladder tone. Such blocking leads to less frequent urination and thus potential improvement in UI. However, antimuscarinic drugs also block many other effects of acetylcholine, including secretions of the respiratory tract, gastrointestinal system, and salivary glands, and actions on the central nervous system, the iris and ciliary muscle of the eye, heart, and blood vessels. Acetylcholine blocking leads to adverse effects, including dry mouth, dry eye, constipation, confusion, headache, blurred vision, and others.124,127129 Previously published advocacy reviews did not focus on comparative safety of these drugs in adult women.130137 Moreover, many recently published studies have not yet been synthesized into clinical recommendations for physicians.

Comprehensive and up-to-date reviews of treatment options for women with UI are necessary in order to develop evidence-based guidelines and recommendations for patients, clinicians, and policymakers.8,138140

This report synthesizes published evidence about diagnosis and management of UI in adult women. We focused on adult women and on nonsurgical, nonpharmacological treatments appropriate to primary care ambulatory practice, as well as pharmacological agents available in the United States. This report is intended as a companion piece to an earlier Evidence-based Practice Center report9 that examined a wide range of treatment alternatives, including surgery.

Our systematic review is intended to help clinicians, consumers, and policymakers make clinical recommendations and informed decisions based on synthesized evidence and other relevant factors.

We examined the following questions:

Key Question 1. What constitutes an adequate diagnostic evaluation for women in the ambulatory care setting on which to base treatment of urinary incontinence?

  1. What are the diagnostic values of different methods—questionnaires, checklists, scales, self-reports of UI during a clinical examination, pad tests, and ultrasound—when compared with multichannel urodynamics?
  2. What are the diagnostic values of different methods—questionnaires, checklists, scales, self-reports of UI during a clinical examination, pad tests, and ultrasound—when compared with a bladder diary?
  3. What are the diagnostic values of the methods listed above for different types of UI, including stress, urgency, and mixed incontinence?
  4. What is the association between patient outcomes (continence, severity and frequency of UI, quality of life) and UI diagnostic methods?

Key Question 2. How effective is the pharmacological treatment of UI in women?

  1. How do pharmacologic treatments affect continence, severity and frequency of UI, and quality of life when compared with no active treatment or with combined treatment modalities?
  2. What is the comparative effectiveness of pharmacological treatments when compared with each other or with nonpharmacological treatments of UI?
  3. What are the harms from pharmacological treatments when compared with no active treatment?
  4. What are the harms from pharmacological treatments when compared with each other or with nonpharmacological treatments of UI?
  5. Which patient characteristics, including age, type of UI, severity of UI, baseline disease that affects UI, adherence to treatment recommendations, and comorbidities, can modify the effects of the pharmacological treatments on patient outcomes, including continence, quality of life, and harms?

Key Question 3. How effective is the nonpharmacological treatment of UI in women?

  1. How do nonpharmacological treatments affect incontinence, UI severity and frequency, and quality of life when compared with no active treatment?
  2. How do combined modalities of nonpharmacological treatments with drugs affect incontinence, UI severity and frequency, and quality of life when compared with no active treatment or with monotherapy?
  3. What is the comparative effectiveness of nonpharmacological treatments when compared with each other?
  4. What are the harms from nonpharmacological treatments when compared with no active treatment?
  5. What are the harms from nonpharmacological treatments when compared with each other?
  6. Which patient characteristics, including age, type of UI, severity of UI, baseline disease that affects UI, adherence to treatment recommendations, and comorbidities, can modify the effects of the nonpharmacological treatments on patient outcomes, including continence, quality of life, and harms?

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