Comparative Effectiveness Review Number 36 Effective Health Care Program Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness Executive Summary Background Effective Health Care Program Urinary incontinence (UI) is the The Effective Health Care Program involuntary loss of urine.1 About was initiated in 2005 to provide 25 percent of young women,2 44 to valid evidence about the comparative to 57 percent of middle-aged and effectiveness of different medical postmenopausal women,3 and about interventions. The object is to help 75 percent of older women experience consumers, health care providers, some involuntary urine loss.4 UI can and others in making informed affect women’s physical, psychological, choices among treatment alternatives. and social well-being, and sometimes Through its Comparative Effectiveness imposes significant lifestyle restrictions. Reviews, the program supports The effects of UI range from slightly systematic appraisals of existing bothersome to debilitating. scientific evidence regarding The cost of incontinence care in the treatments for high-priority health United States averaged $19.5 billion conditions. It also promotes and in 2004.5 Six percent of nursing home generates new scientific evidence by admissions of older women are identifying gaps in existing scientific attributable to UI,5 and by one estimate, evidence and supporting new research. the annualized cost of women’s nursing The program puts special emphasis home admissions due to UI was on translating findings into a variety $3 billion.6 of useful formats for different Nonpharmacological therapies target stakeholders, including consumers. strengthening the pelvic floor and The full report and this summary are changing behaviors that influence bladder available at www.effectivehealthcare. function, whereas pharmacological ahrq.gov/reports/final.cfm. therapies address innervating the bladder and sphincter. The etiology of incontinence is multifactorial; risk factors constipation.7 Assessments of women include age, pregnancy, pelvic floor complaining of UI begin with exclusion trauma after vaginal delivery, menopause, of underlying causes such as pelvic organ hysterectomy, obesity, urinary tract prolapse, urinary tract infection, and poor infections, functional and/or cognitive bladder emptying,8 all of which are beyond impairment, chronic cough, and the scope of this review, as is neurogenic Effective Health Care 1 UI associated with spinal cord injury or stroke.9 We focus stress UI, surgical treatments.1 In addition, several drugs specifically on women with stress UI associated with have been approved for adults with overactive bladder, sphincter function, and with urgency UI, often associated with or without urgency UI.1 Clinical interventions to with overactive bladder (Table 1 in the full report). reduce the frequency of UI episodes in women have been 8,11 Incontinence types are distinguished by their baseline extensively reviewed in recent years, but the reviews mechanisms. Stress incontinence is associated with did not emphasize continence or women’s perceptions of impaired sphincter function, and results in an inability treatment success and satisfaction. Continence (complete 9 voluntary control of the bladder) has been considered a to retain urine during coughing or sneezing. Urgency 8,12 incontinence is defined as involuntary loss of urine primary goal in UI treatment and is the most important outcome associated with quality of life in women with associated with the sensation of a sudden compelling urge 13 9 UI; yet, it is rarely examined as a primary outcome in to void that is difficult to defer. Mixed UI is the term 14 applied when both stress and urgency UI are present. These syntheses of evidence. Thus, we focus on continence and definitions reflect the consensus definitions developed quality of life as primary outcomes for this Comparative by the International Urogynecological Association/ Effectiveness Review. International Continence Society.9 Overactive bladder is While definitions of continence are similar, the definitions defined as urinary urgency with or without incontinence, most commonly applied to improvement in UI vary and usually accompanied by frequency and nocturia (the need include different degrees of change in frequency and to urinate at night).9 Approximately one-third of women severity of symptoms.15 Furthermore, improvement with overactive bladder also experience urgency UI. in UI has been viewed very differently by women and The types of UI imply different attendant risk factors by researchers. Women define improvement according and recommended treatments; however, UI etiology to reduced lifestyle restrictions or improved overall is frequently mixed.8 Stress UI is more common in perception of bladder symptoms, especially resolution of younger women in association with pelvic floor trauma urine leakage, whereas researchers define improvement as and uterine prolapse, both of which are often related to a decrease in the amount of lost urine during pad tests, or 7 any statistically significant decrease in the frequency of vaginal delivery and may require surgical treatments. 15 Urgency and mixed UI are more common in older women UI episodes. Treatments for overactive bladder aim to in association with overactive bladders with or without decrease the frequency and intensity of urgency sensations, sphincter dysfunction.1,7 as well as the frequency of urgency UI episodes. Previous reviews of treatments for overactive bladder have Although UI can be diagnosed based on patients’ reports of considered clinical success as any statistically significant involuntary urine leakage,7 researchers have also proposed decrease in the frequency of UI episodes and voiding, clinical methods for objective diagnosis of different UI irrespective of whether women perceived improvement.14 types. Urodynamic diagnosis of pure stress UI without Measurement of treatment outcomes should be patient detrusor overactivity has demonstrated usefulness for centered and based on factors important to women, rather women undergoing surgery for stress UI.9 Diagnostic than on the results of invasive tests.12 Thus, treatment studies use multichannel urodynamics as a reference success and failure should be evaluated according to standard test to compare with noninvasive tests applicable what women report in validated questionnaires or scales. to ambulatory care. However, researchers disagree on Ultimately, discussions of UI are complicated by the wide whether urodynamic examination represents the gold variety of measures used to describe the problem and its standard for UI diagnosis.8 Furthermore, urodynamic treatment outcomes. This review examines improvement examination is not possible in ambulatory primary care. thresholds of clinical importance in validated scales Previously published systematic reviews have reported a and checklists that can be applied to judge UI treatment weak association between urodynamic test results and self- success according to women’s own perceptions. reported symptoms,10 but these reviews did not focus on the most appropriate methods to distinguish different types This report synthesizes published evidence about of UI in ambulatory care settings. The role of invasive diagnosis and management of UI in adult women. We diagnostic methods in predicting which patients will focused on adult women in ambulatory care settings benefit from specific treatments for UI remains unclear. and on nonsurgical nonpharmacological treatments and pharmacological agents available in the United States. Standard UI treatments for women include lifestyle This report is intended as a companion piece to an earlier changes, pelvic floor muscle training, and, for predominant Evidence-based Practice Center report7 that examined a 2 wide range of treatment alternatives, including surgery. self-reports of UI during a clinical examination, We focus on techniques appropriate to primary care pad tests, and ultrasound—when compared with ambulatory practice and nonsurgical interventions for multichannel urodynamics? women with refractory UI. 2. What are the diagnostic values of different methods— Our report also addresses the role of urodynamic testing, questionnaires, checklists, scales, self-reports of which is not typically performed in primary care. We UI during a clinical examination, pad tests, and include it here primarily as background information ultrasound—when compared with a bladder diary? for primary care practitioners, and because it raises 3. What are the diagnostic values of the methods listed a conundrum. As we have emphasized, the primary above for different types of UI, including stress, outcome for UI should be patient-centered reports of the urgency, and mixed incontinence? UI experience, especially the presence or absence of UI. Although we typically think of physiological testing as 4. What is the association between patient outcomes more objective than patient reports, these results are, at (continence, severity and frequency of UI, quality of best, akin to intermediate outcomes. In the diagnostic life) and UI diagnostic methods? context, physiological testing can inform in one of three Key Question 2. How effective is the pharmacological ways: (1) establishing a diagnosis, (2) determining an treatment of UI in women? etiology with therapeutic implications, and (3) generating a prognosis. In the case of UI, it is unclear whether 1. How do pharmacologic treatments affect continence,