Future Directions of Research and Care for Urinary Incontinence: Findings from the National Institute of Diabetes and Digestive and Kidney Diseases Summit on Urinary Incontinence Clinical Research in Women.

PURPOSE: Female urinary incontinence is prevalent, costly and morbid. Participants in a NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) sponsored summit reviewed findings from NIH (National Institutes of Health) funded clinical research on urinary incontinence in women and discussed the future of urinary incontinence research. MATERIALS AND METHODS: The NIDDK convened the Summit on Urinary Incontinence Clinical Research in Women on March 14, 2014. Participants representing a broad range of clinical expertise reviewed completed NIH sponsored urinary incontinence related studies, including results from community based epidemiological studies such as the BACH (Boston Area Community Health) Survey and from randomized clinical trials such as PRIDE (Program to Reduce Incontinence by Diet and Exercise), and studies conducted by the Pelvic Floor Disorders Network and the Urinary Incontinence Treatment Network. RESULTS: BACH Survey results improved our understanding of precursors, incidence, prevalence and natural history of urinary incontinence in a diverse group of women. The Pelvic Floor Disorders Network study found that anticholinergic medications and onabotulinumtoxinA are efficacious for treating urge urinary incontinence, and Burch colposuspension and retropubic mid urethral polypropylene slings are efficacious for decreasing stress urinary incontinence following pelvic organ prolapse surgery in women with potential stress urinary incontinence. The Urinary Incontinence Treatment Network study found that fascial slings were better than colposuspension, and that retropubic and transobturator mid urethral polypropylene slings were equivalent for stress urinary incontinence. In patients with stress urinary incontinence a preoperative urodynamic study was noninferior to basic office examinations for surgical outcome. The addition of behavioral intervention did not allow female patients to discontinue antimuscarinics for urge urinary incontinence. PRIDE showed that modest weight reductions significantly decreased urinary incontinence. CONCLUSIONS: Strategies for future research on urinary incontinence should include a focus on early disease, risk factor identification, better phenotyping, incorporation of new technologies, patient centered research and prevention.

Comparison of mindfulness-based stress reduction versus yoga on urinary urge incontinence: a randomized pilot study. with 6-month and 1-year follow-up visits.

OBJECTIVES: The objective of this study is to compare the effects of mindfulness-based stress reduction (MBSR) versus yoga on urinary urge incontinence (UI) at 8 weeks, 6 months, and 1 year after beginning an 8-week program. MATERIALS AND METHODS: Participants in this prospective randomized single-masked pilot study were women aged 18 years or older with urge-predominant incontinence, 5 or more UI episodes (UIEs) on a 3-day voiding diary, and no recent anticholinergic use. Women were randomized to MBSR or yoga. The primary outcome was the percent change of UIE. RESULTS: Of 30 enrollees (15 in MBSR, 15 in yoga), 24 completed at least 5 of 8 sessions (13 in MBSR and 11 in yoga). Twenty and 21 women completed the 6-month and 12-month follow-up visits, respectively. At 8 weeks, 6 months, and 12 months, the median percent change from the baseline in UIE on the intention-to-treat analysis was greater for the MBSR group (-55.6, -71.4, and -66.7, respectively) compared with that for the yoga group (-33.3, -11.8, and -16.7, respectively), with P values ranging from 0.01 to 0.08. On intention-to-treat analysis, the median percent change in the Overactive Bladder Symptom and Quality of Life-Short Form and the Health-Related Quality of Life was greater at each time point for MBSR than for yoga but was statistically significant only at 8 weeks (P = 0.003 and 0.02, respectively). As per protocol analysis, at 8 weeks, 6/13 and 0/11 women in MBSR and yoga, respectively, reported they were very much or much better (P = 0.02), whereas at 1 year, 6/12 and 1/9 women in MBSR and yoga, respectively, did so (P = 0.16). DISCUSSION: These results support larger scale trials to evaluate MBSR, which seems to be a promising treatment of UI.

Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery.

AIMS: To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery. METHODS: Women with predominant stress urinary incontinence (SUI) as part of the trial of mid-urethral slings (TOMUS) were characterized preoperatively including: demographics, body mass index (BMI), responses to the Medical and Epidemiologic Social Aspects of Aging (MESA) and Urogenital Distress Inventory (UDI) questionnaires, pad weight (PW), incontinence duration, prior SUI surgery, prolapse, strength of pelvic contraction, Q-tip test, uroflow, cystometrogram, and detrusor pressures at maximum flow (Pdet at Qmax). Multivariate regression analysis and modeling confirmed variables with significant correlations with maximal urethral closure pressure (MUCP), functional urethral length (FUL), and Valsalva leak point pressure (VLPP). RESULTS: Five-hundred thirty-nine women were included in the analysis. In multivariable analyses, PW (P = 0.045) and age (P < 0.0001) were negatively correlated with MUCP (as PW and age increased, MUCP decreased); BMI (P = 0.02) and Pdet at Qmax (P < 0.0001) were positively correlated with MUCP (as BMI and Pdet at Qmax increased, MUCP increased). Age (P = 0.002) was negatively correlated with FUL; Qtip delta (P = 0.006), pelvic organ prolapse quantification examination (POPQ) stage (P = 0.002) and strength of pelvic contraction (P = 0.03) were positively correlated with FUL. Duration of incontinence (P = 0.01) was negatively correlated with VLPP; Qtip delta (P = 0.02), BMI (P = 0.0005) and Pdet at Qmax (P = 0.0005) were positively correlated with VLPP. CONCLUSIONS: Age, BMI, Qtip delta, and Pdet at Qmax were variables that correlated with two or more measures of urethral function. These correlations may help direct future research in female urethral function.

Mindfulness-based stress reduction for treatment of urinary urge incontinence: a pilot study.

OBJECTIVE: The objective of the study was to evaluate if a mindfulness-based stress reduction program is a viable treatment worthy of further evaluation for the treatment of urinary urge incontinence. METHODS: This was a single-arm pilot study of 7 women who participated in an 8-week mindfulness-based stress reduction program to evaluate its effectiveness in reducing urinary leakage episodes. Improvement was measured by 3-day bladder diary, Overactive Bladder Symptom and Quality of Life-Short Form, Health-Related Quality of Life, and Patient Global Impression of Improvement. Outcome data were analyzed by means of paired t tests. RESULTS: Mean incontinence episodes per day decreased from 4.14 (SD, 1.96; range, 2.67-7.67) at baseline to 1.23 (SD, 0.93; range, 0.33-2.67) after treatment (P = 0.0005 for change). After treatment, 5 of 7 women were improved based on the Patient Global Impression of Improvement, and 2 were unchanged. Significant improvements on both Health-Related Quality of Life and Overactive Bladder Symptom and Quality of Life-Short Form were reported after treatment. Results were sustained at 1 year in 4 of 7 women. Two women sought treatment, and one was lost to follow-up at 12 months. CONCLUSIONS: Mindfulness-based stress reduction appears to be a treatment worthy of further study, as in the short term, it is as effective as historical studies of drug treatment and bladder training in reducing urge incontinence and incontinence-related quality of life.

Normal preoperative urodynamic testing does not predict voiding dysfunction after Burch colposuspension versus pubovaginal sling.

PURPOSE: Urodynamic studies have been proposed as a means of identifying patients at risk for voiding dysfunction after surgery for stress urinary incontinence. We determined if preoperative urodynamic findings predict postoperative voiding dysfunction after pubovaginal sling or Burch colposuspension. MATERIALS AND METHODS: Data were analyzed from preoperative, standardized urodynamic studies performed on participants in the Stress Incontinence Treatment Efficacy Trial, in which women with stress urinary incontinence were randomized to undergo pubovaginal sling surgery or Burch colposuspension. Voiding dysfunction was defined as use of any bladder catheter after 6 weeks, or reoperation for takedown of a pubovaginal sling or Burch colposuspension. Urodynamic study parameters examined were post-void residual urine, maximum flow during noninvasive flowmetry, maximum flow during pressure flow study, change in vesical pressure at maximum flow during pressure flow study, change in abdominal pressure at maximum flow during pressure flow study and change in detrusor pressure at maximum flow during pressure flow study. The study excluded women with a preoperative post-void residual urine volume of more than 150 ml or a maximum flow during noninvasive flowmetry of less than 12 ml per second unless advanced pelvic prolapse was also present. RESULTS: Of the 655 women in whom data were analyzed voiding dysfunction developed in 57 including 8 in the Burch colposuspension and 49 in the pubovaginal sling groups. There were 9 patients who could not be categorized and, thus, were excluded from the remainder of the analysis (646). A total of 38 women used a catheter beyond week 6, 3 had a surgical takedown and 16 had both. All 19 women who had surgical takedown were in the pubovaginal sling group. The statistical analysis of urodynamic predictors is based on subsets of the entire cohort, including 579 women with preoperative uroflowmetry, 378 with change in vesical pressure, and 377 with change in abdominal and detrusor pressure values. No preoperative urodynamic study findings were associated with an increased risk of voiding dysfunction in any group. Mean maximum flow during noninvasive flowmetry values were similar among women with voiding dysfunction compared to those without voiding dysfunction in the entire group (23.4 vs 25.7 ml per second, p = 0.16), in the Burch colposuspension group (25.8 vs 25.7 ml per second, p = 0.98) and in the pubovaginal sling group (23.1 vs 25.7 ml per second, p = 0.17). Voiding pressures and degree of abdominal straining were not associated with postoperative voiding dysfunction. CONCLUSIONS: In this carefully selected group preoperative urodynamic studies did not predict postoperative voiding dysfunction or the risk of surgical revision in the pubovaginal sling group. Our findings may be limited by the stringent exclusion criteria and studying a group believed to be at greater risk for voiding dysfunction could alter these findings. Additional analysis using subjective measures to define voiding dysfunction is warranted to further determine the ability of urodynamic studies to stratify the risk of postoperative voiding dysfunction, which appears to be limited in the current study.

Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial.

BACKGROUND: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. OBJECTIVE: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. DESIGN: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006. SETTING: 9 university-affiliated outpatient clinics. PATIENTS: 307 women with urge-predominant incontinence. INTERVENTION: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months. MEASUREMENTS: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. RESULTS: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]). LIMITATIONS: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%. CONCLUSION: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.

Urodynamic measures do not predict stress continence outcomes after surgery for stress urinary incontinence in selected women.

PURPOSE: We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence. MATERIALS AND METHODS: In a 9-center surgical trial, women with stress urinary incontinence were randomized to a Burch or pubovaginal sling procedure. Women were eligible for the study if they had predominant stress urinary incontinence symptoms, a positive cough stress test, a bladder capacity more than 200 ml and urethral hypermobility. Preoperative free uroflowmetry, filling cystometry and pressure flow studies were performed in all. Overall treatment success required a negative pad test, no urinary incontinence on a 3-day diary, a negative stress test, no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence. Stress specific success required all of the last 3 criteria. We examined urodynamic measures, and whether the presence of urodynamic stress incontinence, the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success. RESULTS: Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group, but this trend did not quite reach statistical significance (OR 2.26; 95% C.I. 0.99, 5.17). Odds of stress specific success did not differ by urodynamic stress incontinence status. Subjects with detrusor overactivity did not have significantly worse success rates. Stratifying by treatment group, there was no difference in mean Valsalva leak point pressure values between surgical successes and failures. CONCLUSIONS: We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence. The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence. The impact of urodynamic studies on surgical outcomes needs further investigation.

The relationships among measures of incontinence severity in women undergoing surgery for stress urinary incontinence.

PURPOSE: We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques (Burch colposuspension vs pubovaginal sling) for stress urinary incontinence. MATERIALS AND METHODS: A total of 655 women underwent a standardized preoperative assessment that included the Medical, Epidemiological and Social Aspects of Aging questionnaire, Urogenital Distress Inventory, Incontinence Impact Questionnaire, 3-day voiding diary, 24-hour pad test, a supine empty bladder stress test and Valsalva leak point pressure measurements. Correlations were estimated using Spearman correlation coefficients and 95% confidence intervals. T tests at alpha=0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test. RESULTS: Baseline mean scores on Medical, Epidemiological and Social Aspects of Aging, Urogenital Distress Inventory and Incontinence Impact Questionnaire were 25.8, 151 and 171, respectively. Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm, respectively. Supine empty bladder stress test was positive in 218 patients, and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H(2)O. Weak to moderate correlations were observed between Medical, Epidemiological and Social Aspects of Aging, incontinence episode frequency, pad weight, Incontinence Impact Questionnaire and Urogenital Distress Inventory. On the other hand, Valsalva leak point pressure correlated poorly with all variables measured. The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49% and 60%, respectively. CONCLUSIONS: Urinary incontinence severity measures correlate moderately with each other at best. While Medical, Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life, Valsalva leak point pressure did not. Supine empty bladder stress test did not demonstrate a clinically significant association among severity measures.