Background
Urinary incontinence (UI) is an important health concern that has a substantial effect on an individual’s perception of well-being, body image, and quality of life (QoL). It is estimated that 13 million people in the United States, of which 11 million are women, suffer from UI [1]. The actual prevalence of urinary incontinence in women is not known. Most women who experience urinary incontinence never seek or receive treatment [2,3]. A limitation of existing national databases is that they capture only the minority of incontinent women who are treated for incontinence [4]. Despite underestimation, UI is a prevalent condition in the female population in the United States. It affects 15–50%, and prevalence increases with age. In younger age groups under 25 years, the prevalence is low, less than 5%. Prevalence rises steadily until the postmenopausal years when it is greater than 30%. Stress urinary incontinence (SUI) is the most common type of urinary incontinence and is present in approximately 50% of incontinent women whereas pure urge incontinence exists in approximately 22% of women [4].
Urinary incontinence may be managed in a variety of medical and surgical ways. Medical management of female urinary incontinence is a broad term that encompasses several modalities including behavioral therapy, pelvic floor muscle therapy (PFMT), with or without the assistance of electrical stimulation or biofeedback, and pharmacological therapy. Antimuscarinic agents are the standard treatment for urge incontinence, but there is no Food and Drug Administration-approved drug for stress urinary incontinence.
The Agency for Healthcare Research Quality (AHRQ) clinical practice guideline on UI in adults recommends behavioral modification as first-line intervention for UI [5]. Behavioral modification includes a variety of activities such as education, lifestyle changes, keeping micturition charts and diaries, development of timed voiding and bladder training regimens, and physiotherapy with or without biofeedback. The AHRQ recommendations are based on available high-level evidence supporting the effectiveness of these interventions. However, less outcomes evidence is available about use of these interventions in clinical practice.
Pelvic floor muscle therapy for UI is the best studied nonsurgical treatment. It is useful for both stress and urge incontinence because it improves the strength of pelvic floor musculature and thus urethral support, whereas contraction of striated paraurethral musculature simultaneously causes reflex inhibition of detrusor contractions. A variety of PFMT protocols exist, which hampers comparison between studies.
Clinical question 20.1
Is there a role for education, behavioral and lifestyle modification alone for female urinary incontinence (stress and urge)?
Literature search
Evidence for the following clinical recommendations was obtained using three separate methods to ensure completeness and timeliness. First, Medline searches were conducted including all forms of published, English-language studies using the keywords: “education,” “behavioral modification,” “lifestyle modification,” “female urinary incontinence.” The references of these studies were in turn examined for further relevant studies that may have been missed in the search. Next, texts considered authoritative in the field were reviewed with specific attention to the studies used to form those resources’ clinical recommendations. This also included searches at meta-analyses clearing houses. Finally, active practitioners and researchers within the field were queried about recent evidence on the topic and what studies they used to inform their own clinical decision making. The sum of information found through all the above means was reviewed and the following clinical recommendations are made based on this evidence.
The evidence
Lifestyle interventions for the treatment of UI are of significant interest to patients, yet there is limited high-level evidence to guide practice recommendations. Weight reduction is the behavioral and lifestyle change that has received the most attention as a treatment option for urinary incontinence. Hunskaar has published a well-researched review of the epidemiological literature of urinary incontinence with respect to overweight and obesity as risk factors [6]. The association of overweight and obesity with urinary incontinence is well established but epidemiological evidence is only fair (Level 2 and 3). Many of the studies are composed of samples of patients planning bariatric surgery; thus, they are biased populations and contain a large number of very obese patients who are not found in population-based studies. However, credible evidence from longitudinal studies that link high Body Mass Index (BMI) to the later development of new urinary incontinence is present. The connection between obesity and incontinence is greater for stress and mixed incontinence than for urge incontinence and overactive bladder (OAB) [6].
Three randomized controlled trials (RCTs) of weight reduction as treatment for urinary incontinence have been published. The first large-scale RCT to examine weight loss was the Program to Reduce Incontinence by Diet and Exercise (PRIDE) study. This was carried out at two US sites and enrolled 338 overweight or obese women reporting > 10 episodes of incontinence weekly [7]. Participating women were randomized 2:1 to an intensive 6-month lifestyle and behavior change weight intervention program (N 226) or to a structured education group (control group, N 112). Stratification was also performed according to clinical center. Participants were aware of their treatment of course, but staff members who collected the outcome data were blinded. All women received an instructional guide of standard behavioral therapy for incontinence and were trained to complete a 7-day voiding diary. The primary outcome measure was the percentage change in the number of incontinence episodes reported in the 7-day diary at 6 months after randomization. Results showed that the characteristics of the participants in the two groups were similar at baseline and rates of urge incontinence were greater than stress incontinence. At 6 months, the weight loss group had a mean loss of 8.0% of bodyweight from baseline and a 47.4% mean decrease in the total number of incontinence episodes per week compared to a 1.6% weight loss (p < 0.001) and 28.1% mean decrease in incontinence episodes in the control group (p = 0.01). The main reduction in incontinence episodes from baseline was within episodes of stress incontinence, although the frequency of episodes of urge incontinence was greater in the weight loss group but not by a statistically significant extent. Women in the weight loss group also perceived a greater decrease in the frequency of urinary incontinence episodes and a lower volume of urine loss and reported higher satisfaction with change (p < 0.001). However, the increased awareness of bladder habits resulting from voiding diary compliance could contribute to improvement in both groups.
Fluid restriction is typically supported for the treatment of urge incontinence but there are few published randomized trials to support its use. Hashim & Abrams reported a small randomized, two-group, prospective, cross-over trial in adults with symptoms of OAB [8]. Twenty-four adult men and women with significant OAB symptoms on frequency/volume charts and having urgency and/or urge incontinence were assigned to either an increased or a decreased fluid intake regimen. The primary endpoint was the change in the frequency of urgency and/or urge incontinence events during a 24-hour period. A key finding was that adults find it easier to increase or decrease fluid intake by 25% of baseline rather than 50% (a target in earlier trials that led to poor compliance with study design) [9]. Additionally, there was a significant reduction in frequency, urgency, and nocturia when patients decreased their fluid input by 25%, but no statistically significant improvement in quality of life. With regard to whether caffeine intake contributes to OAB symptomatology, Swithinbank et al. conducted a 4-week prospective, randomized cross-over study in 30 women with urodynamically confirmed detrusor overactivity to determine the effect of caffeine restriction as well as fluid volume manipulation on urinary symptoms [10]. Interestingly, no significant difference between the baseline week and caffeine-free week was found for any outcome measures. Fluid restriction from baseline did achieve a statistically significant decrease in voiding frequency and urgency episodes, supporting the Hashim & Abrams study results.
Pelvic floor muscle therapy is a commonly prescribed conservative treatment for urinary incontinence, but a recent meta-analysis reveals the limitations of the existing evidence. In 2008, Shamliyan et al. published a large-scale review synthesizing evidence on the effectiveness of nonsurgical clinical interventions for the treatment of urinary incontinence in women [11]. Ninety-six RCTs and three systematic reviews were examined and of those, 31 addressed PFMT. Four RCTs supported PFMT over “regular care” for improvement in UI with moderate level of evidence, defined as the confidence that the estimate of effect would likely change with future research. Within these studies, pooled relative risk for continence after PFMT and PFMT with biofeedback was significant and consistent. However, pooled absolute risk differences of resolved or improved UI were inconsistent across the studies. Analysis between studies is hampered by the difference in behavioral training/PFMT protocol between studies.
Moderate-level evidence also exists to support PFMT and bladder training compared to regular care, although improvement effect was inconsistent across the studies. The authors compared results of individual studies to analyze the effectiveness of PFMT by population and treatment characteristics, and factors that portend a favorable prognosis/outcome were: PFMT in groups with skilled physical therapists, individualized behavioral intervention with PFMT, and community-based interventions including education, bladder training and PFMT [11].
The Cochrane Incontinence Group Specialized Trials Register searched randomized or quasi-randomized trials in women with stress, urge or mixed incontinence in which one arm of the trial included PFMT (defined simply as a program of repeated voluntary pelvic floor muscle contractions taught and supervised by a healthcare professional) and another arm was a no-treatment, placebo, sham or other inactive control [12]. Thirteen trials involving 714 women (375 PFMT, 339 controls) met the inclusion criteria, but only six trials (403 women) contributed data to the analysis. The reviewers identified limitations in the studies including moderate to high risk of bias in most as well as considerable variation in interventions used, study populations, and outcome measures. Results suggest that women who did PFMT were more likely to report they were cured or improved as compared to women who did not participate. Women who underwent PFMT also experienced about one fewer incontinent episodes per day. Conclusions drawn include support for the widespread recommendation that PFMT be included in first-line conservative management of stress, urge or mixed UI in women, yet tempered by recognition of statistical heterogeneity from variations in incontinence type, training, and outcome measurement between studies.
Biofeedback uses visual cues and verbal coaching to teach patients how to control the physiological responses of the bladder and pelvic floor muscles that control continence. Biofeedback-assisted PFMT has been shown to be as effective as pharmacotherapy for urge incontinence, and superior to immediate-release oxybutynin in one randomized trial [13]. There is low Level 1 evidence that biofeedback-assisted PFMT is no more effective than PFMT alone for women with stress and mixed incontinence. Nonetheless, in clinical practice, physicians may find biofeedback a useful adjunct to PFMT, particularly in women who have difficulty isolating pelvic floor muscles. Large-scale RCTs are needed to study the best use of biofeedback in PFMT. Data in support of electrical stimulation for UI are insufficient, and electrical stimulation with PFMT seems not to offer benefit. Further investigation of these modalities is necessary.