BACKGROUND Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval, −7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.)

Background Female urinary microbiota (FUM) are associated with urgency urinary incontinence (UUI) and response to UUI medication. FUM of women with stress urinary incontinence (SUI) has not been described. Objective Study the cross-sectional relationships between FUM features and demographic and clinical characteristics of women undergoing SUI surgery. Design, Setting, and Participants Pre-operative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multi-center prospective randomized trial, the Value of Urodynamic Evaluation (ValUE) study. Demographic and clinical variables were obtained including SUI and UUI symptoms, menopausal status, and hormone use. Outcome Measurements and Statistical Analysis The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S rRNA gene. Phylogenetic relatedness and microbial alpha diversity were compared to demographics and symptoms using generalized estimating equation models. Results The majority of 197 urine samples (86%) had detectable bacterial DNA. Bacterial diversity was significantly associated with higher BMI (p=0.02), increased Medical, Epidemiologic, and Social Aspects of Aging (MESA) urge index score (p=0.04), and hormonal status (p<0.001). No associations were detected with SUI symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women. Conclusions Women undergoing SUI surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with UUI symptoms, hormonal status and BMI. In contrast, the FUM was not associated with stress urinary incontinence symptoms.

Lower urinary tract symptoms (LUTS) are highly prevalent in women, and are expected to impose a growing burden to individuals and society as the population ages. The predominance of research related to LUTS has focused on underlying pathology, disease mechanisms, or the efficacy of treatments for women with LUTS. Although this research has been vital for helping to reduce or ameliorate LUTS conditions, it has done little to prevent the onset of LUTS. Health promotion and prevention require an expansion of scientific inquiry beyond the traditional paradigm of studying disease mechanisms and treatment to the creation of an evidence base to support recommendations for bladder health promotion and, in turn, prevention of LUTS. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) introduced the concept of prevention as an important priority for women's urologic research as a prelude to supporting the formation of the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium. In this article, we introduce the PLUS research consortium to the scientific community; share the innovative paradigms by which the consortium operates; and describe its unique research mission: to identify factors that promote bladder health across the life course and prevent the onset of LUTS in girls and women.

Background Few studies have characterized longer-term outcomes after retropubic and transobturator midurethral slings. Methods Women completing 2-year participation in a randomized equivalence trial who had not received surgical retreatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no retreatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. Results 404 of 597 (68%) women from the original trial enrolled. Five-years after surgical treatment, success was 7.9% greater in women assigned to retropubic-sling compared to transobturator-sling (51.3% vs 43.4%, 95% CI −1.4%, 17.2%) not meeting pre-specified criteria for equivalence. Satisfaction decreased over 5-years, but remained high and similar between arms (79%, retropubic-sling vs 85%, transobturator-sling groups, p=0.15). Urinary symptoms and quality of life worsened over time (p<0.001), and women with retropubic-sling reported greater urinary urgency (P=0.001), more negative quality of life impact (p=0.02), and worse sexual function (P=0.001). There was no difference in proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic-sling-3, transobturator-sling-4). Conclusion Treatment success declined over 5-years for retropubic and transobturator-slings and did not meet pre-specified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing transobturator-sling reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.

Objective-To identify clinical and demographic factors predictive of midurethral sling failure.Methods-Overall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or re-treatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire (MESA), incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure versus subjective failure only. Financial Disclosure: Dr. Richter has been a consultant for Xanodyne Pharmaceuticals, Uromedica, and IDEO. She has received research grants and has been a consultant for Pfizer and Astellas. She has also received an education grant from Warner Chilcott. Dr. Lukacz has been a consultant and advisor to Pfizer and Watson. Dr. Fitzgerald has received a research grant from Astellas and speaker honorarium from Astellas, Pfizer, and Ferring. She also has been a consultant to Pfizer and Astellas. Dr. Rickey received research support from Pfizer and is a consultant for Ethicon. The other authors did not report any potential conflicts of interest. Conclusion-Twelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure. NIH Public Access