Lower Urinary Tract Symptoms in US Women: Contemporary Prevalence Estimates from the RISE FOR HEALTH Study.

PURPOSE: We aimed to estimate the prevalence of a wide range of lower urinary tract symptoms (LUTS) in US women, and explore associations with bother and discussion with health care providers, friends, and family. MATERIALS AND METHODS: We analyzed baseline data collected from May 2022 to December 2023 in the RISE FOR HEALTH study-a large, regionally representative cohort study of adult female community members. LUTS and related bother were measured by the 10-item Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index, and discussion was assessed by a study-specific item. RESULTS: Of the 3000 eligible participants, 73% (95% CI 71%-74%) reported any storage symptoms, 52% (95% CI 50%-53%) any voiding or emptying symptoms, and 11% (95% CI 10%-13%) any pain with bladder filling, for an overall LUTS prevalence of 79% (95% CI 78%-81%). This prevalence estimate included 43% (95% CI 41%-45%) of participants with mild to moderate symptoms and 37% (95% CI 35%-38%) with moderate to severe symptoms. Over one-third of participants reported LUTS-related bother (38%, 95% CI 36%-39%) and discussion (38%, 95% CI 36%-40%), whereas only 7.1% (95% CI 6.2%-8.1%) reported treatment. Urgency and incontinence (including urgency and stress incontinence) were associated with the greatest likelihood of bother and/or discussion (adjusted prevalence ratios = 1.3-2.3), even at mild to moderate levels. They were also the most commonly treated LUTS. CONCLUSIONS: LUTS, particularly storage LUTS such as urgency and incontinence, were common and bothersome in the RISE study population, yet often untreated. Given this large burden, both prevention and treatment-related interventions are warranted to reduce the high prevalence and bother of LUTS.

Validation of bladder health scales and function indices for women's research.

BACKGROUND: Existing bladder-specific measures lack the ability to assess the full range of bladder health, from poor to optimal health. OBJECTIVE: This study aimed to report evidence of validity of the self-administered, multidimensional bladder health scales and function indices for research in adult women. STUDY DESIGN: A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms in 7 clinical research centers. Construct validity of the bladder health scales and function indices was guided by a multitrait-multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed-effects intraclass correlation coefficient models. Chi-square, Fisher exact, or t-tests were used for mode comparisons. Convergent validity was evaluated using Pearson correlations with the external construct measures, and known-group validity was established with comparison of women known and unknown to be symptomatic of urinary conditions. RESULTS: The sample included 1072 participants. Factor analysis identified 10 scales, with Cronbach's alpha ranging from 0.74 to 0.94. Intraclass correlation coefficients of scales ranged from 0.55 to 0.94. Convergent validity of the 10 scales and 6 indices ranged from 0.52 to 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration. CONCLUSION: The paper and electronic forms of the bladder health scales and function indices are reliable and valid measures of bladder health for use in women's health research.

Sling plication for persistent stress urinary incontinence after midurethral sling.

INTRODUCTION AND HYPOTHESIS: Persistent or recurrent stress urinary incontinence after midurethral sling placement is not uncommon. Treatment options include placement of a second midurethral sling, autologous fascial sling, retropubic urethropexy, or urethral bulking. Shortening of the sling by plication has also been suggested as an alternative option which may reduce operative time, cost, risk of trocar injury, and mesh burden. In this video, we aimed to demonstrate our technique and experience on sling plication. METHODS: The key steps of the procedure are as follows: (1) suburethral incision and sharp dissection to identify the sling; (2) mobilization of the suburethral portion of the sling; (3) plication with two interrupted, horizontal sutures placed 1 cm laterally on each side; (4) application of upward pressure while tying the sutures and tensioning the sling. In our experience, we have found this technique to be most successful for retropubic slings, especially when performed within 2-12 weeks of the initial surgery. CONCLUSIONS: Sling plication is an effective and minimally invasive option to treat persistent stress urinary incontinence after failed midurethral sling procedures. It avoids additional mesh burden or more invasive retropubic surgery and should be offered as a treatment option for appropriately counseled patients.

RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women.

INTRODUCTION: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. METHODS AND RESULTS: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. DISCUSSION: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.

Psychosocial Factors Associated with Lower Urinary Tract Symptoms One Year Postpartum.

Pregnancy carries substantial risk for developing lower urinary tract symptoms (LUTSs), with potential lifelong impacts on bladder health. Little is known about modifiable psychosocial factors that may influence the risk of postpartum LUTSs. We examined associations between depressive symptoms, perceived stress, and postpartum LUTSs, and the moderating effects of perceived social support, using data from a cohort study of Expect With Me group prenatal care (n = 462). One year postpartum, 40.3% participants reported one or more LUTS. The most frequent LUTS was daytime frequency (22.3%), followed by urinary incontinence (19.5%), urgency (18.0%), nocturia (15.6%), and bladder pain (6.9%). Higher odds of any LUTS were associated with greater depressive symptoms (adjusted odds ratio (AOR) 1.08, 95% confidence interval (CI) 1.04-1.11) and perceived stress (AOR 1.12, 95% CI 1.04-1.19). Higher perceived social support was associated with lower odds of any LUTS (AOR 0.94, 95% CI 0.88-0.99). Perceived social support mitigated the adverse effects of depressive symptoms (interaction AOR 0.99, 95% CI 0.98-0.99) and perceived stress (interaction AOR 0.97, 95% CI 0.95-0.99) on experiencing any LUTS. Greater depressive symptoms and perceived stress may increase the likelihood of experiencing LUTSs after childbirth. Efforts to promote bladder health among postpartum patients should consider psychological factors and social support.

The Medical Community's Evolving Focus on Physician and Surgeon Pregnancy: Thematic Trends From a Scoping Review.

PURPOSE: The authors aimed to chronicle the evolution of the medical community's study of physician and surgeon pregnancy by investigating thematic trends in the literature in the context of pertinent sociopolitical events. METHOD: A scoping review was conducted in Cochrane Library, Google Scholar, Ovid MEDLINE, Ovid Embase, Scopus, and Web of Science Core Collection from inception through August 11, 2020, using vocabulary and terms for physicians (including surgeons), pregnancy, and family leave. Study populations were categorized by all physician specialties or exclusively surgical specialties as well as by all career levels or exclusively trainees. Subthemes and themes were based on a priori assumptions of physician pregnancy and extrapolated from previously published reviews, respectively. Thematic trends were analyzed by plotting the total number of publications and the frequency of themes and subthemes by publication year. RESULTS: After title and abstract and full-text reviews, 407 manuscripts met inclusion criteria. Publications on physician pregnancy first emerged in the 1960s and surged from 1988 to 1996 and again from 2010 to 2019. The first known manuscript exclusively on surgeon pregnancy was published in 1991; subsequent publication frequency trends for surgeon pregnancy generally paralleled those for all physician pregnancy publications albeit in reduced quantities. Four major themes were found: impact of pregnancy on the physician and her colleagues, pregnant physician work productivity, physician maternity leave policies, and physician maternal-fetal health outcomes. CONCLUSIONS: As the number of women physicians increased and the sociopolitical environment progressed, the thematic focus of the literature on physician pregnancy evolved. Multi-institutional prospective observational studies are needed to develop definitive evidence-based recommendations that will positively impact physician pregnancy.

Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol.

BACKGROUND: Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. METHODS: Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples-women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6-12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach's alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures. DISCUSSION: We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 ( https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1 ).

Measuring Bladder Health: Development and Cognitive Evaluation of Items for a Novel Bladder Health Instrument.

PURPOSE: We describe the item development and cognitive evaluation process used in creating the Prevention of Lower Urinary Tract Symptoms Bladder Health Instrument (PLUS-BHI). MATERIALS AND METHODS: Questions assessing bladder health were developed using reviews of published items, expert opinion, and focus groups' transcript review. Candidate items were tested through cognitive interviews with community-dwelling women and an online panel survey. Items were assessed for comprehension, language, and response categories and modified iteratively to create the PLUS-BHI. RESULTS: Existing measures of bladder function (storage, emptying, sensation components) and bladder health impact required modification of time frame and response categories to capture a full range of bladder health. Of the women 167 (18-80 years old) completed individual interviews and 791 women (18-88 years) completed the online panel survey. The term "bladder health" was unfamiliar for most and was conceptualized primarily as absence of severe urinary symptoms, infection, or cancer. Coping mechanisms and self-management strategies were central to bladder health perceptions. The inclusion of prompts and response categories that captured infrequent symptoms increased endorsement of symptoms across bladder function components. CONCLUSIONS: Bladder health measurement is challenged by a lack of awareness of normal function, use of self-management strategies to mitigate impact on activities, and a common tendency to overlook infrequent lower urinary tract symptoms. The PLUS-BHI is designed to characterize the full spectrum of bladder health in women and will be validated for research use.

Laying the Foundation for Bladder Health Promotion in Women and Girls.

Prevention strategies have been effective in many areas of human health, yet have not been utilized for lower urinary tract symptoms (LUTS) or bladder health (BH). This commentary outlines LUTS prevention research initiatives underway within the NIH-sponsored Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). Prevention science involves the systematic study of factors associated with health and health problems, termed protective and risk factors, respectively. PLUS is enhancing traditional prevention science approaches through use of: (1) a transdisciplinary team science approach, (2) both qualitative and quantitative research methodology (mixed methodology), and (3) community engagement. Important foundational work of PLUS includes development of clear definitions of both BH and disease, as well as a BH measurement instrument that will be validated for use in the general population, adolescents, and Latinx and Spanish-speaking women.1 The BH measurement instrument will be used in an upcoming nationally-representative cohort study that will measure BH and investigate risk and protective factors. PLUS investigators also developed a conceptual framework to guide their research agenda; this framework organizes a broad array of candidate risk and protective factors that can be studied across the life course of girls and women.1 As PLUS begins to fill existing knowledge gaps with new information, its efforts will undoubtedly be complemented by outside investigators to further advance the science of LUTS prevention and BH across additional populations. Once the BH community has broadened its understanding of modifiable risk and protective factors, intervention studies will be necessary to test LUTS prevention strategies and support public health efforts. LUTS providers may be able to translate this evolving evidence for individual patients under their care and act as BH advocates in their local communities.

The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium: A Transdisciplinary Approach Toward Promoting Bladder Health and Preventing Lower Urinary Tract Symptoms in Women Across the Life Course.

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.

Trends in Fellowship Training for Female Pelvic Medicine and Reconstructive Surgery.

OBJECTIVE: The aim of this study was to characterize distinguishing features among gynecology, urology, and combined female pelvic medicine and reconstructive surgery (FPMRS) fellowship programs and practices. METHODS: A 32-item Web-based survey was sent to fellowship directors of FPMRS programs accredited by the Accreditation Council for Graduate Medical Education. The survey assessed the structure of the fellowship, as well as the degree to which gynecology and urology are integrated into the fellowship training. In addition to descriptive statistics, Fisher exact test and Mann-Whitney U test were used for statistical analysis. RESULTS: Forty-one program directors (PDs) completed the survey for a 76% response rate. Of the respondents, 78% were gynecologists, and 22% were urologists. Sixty-five percent of the respondents considered their program gynecology based, 7.5% considered their program urology based, 22.5% considered their program fully integrated (urology and gynecology equal sharing), and 5% have separate tracks for urology fellows and gynecology fellows. Sixty-one percent of the programs accept both urology and gynecology fellows in their fellowship programs. Approximately two thirds of the PDs are happy with the fellowship model at their institution, whereas the remaining one third would like greater integration of gynecology and urology in fellowship training. Almost 90% of the respondents felt that there were benefits to an integrated program. The top benefits were reported as more exchange of information, better relationships, more comprehensive training, exposure to different treatment approaches, and improved care for women. For those PDs who desire a more integrated program, the top barriers listed were departmental competition/politics, lack of formally trained urology faculty, and expense. CONCLUSIONS: There are several FPMRS fellowship models. A significant proportion of PDs would like a more integrated fellowship program, and an overwhelming majority note benefits for themselves and their fellows that result from increased contact with a diverse FPMRS faculty.

Digital Health Care by In Silico Glycation of HbA1 Blood Cells.

BACKGROUND: Diabetes health care relies on the HbA1c (A1c) assay and associated average glucose (AG) to evaluate and control chronic glycemia. However, the A1c assay is plagued with significant noise, lag time, and specificity issues. Current studies support the significant health care advantage of clinical action based on real-time blood glucose (BG) metrics. We seek to improve diabetes management by directly relating such metrics to AG levels as mediated by recently discovered recurrent endocrine cycles. METHODS: Several studies collected multiple months of BG data on 111 subjects totaling 261 893 CGM measurements and 29 278 meter readings. These data are a rich source of multiday metrics in terms of the CGM and SMBG daily profiles. The recurrent endocrine patterns expose key metric relationships for monitoring AG related to A1c using CGM and SMBG data. Consequently, day-to-day tracking of AG is expressed as a simple two-parameter function of fasting BG for all studies. RESULTS: Consequently, when applied to 2518 qualified days of 64 subjects, the function predicts daily AG values with 2% relative standard error. All studies produced compatible results. By restricting one parameter to a constant, the error increased to 3%. CONCLUSIONS: The recurrent endocrine patterns revealed a persistent structure hidden within the multiday fluctuations that becomes a simple meter-compatible equation that accurately measures real-time trending of AG using fasting BG values. This enables a digital health monitoring service and self-monitoring device that reveals immediate disease progression as well as the impact of interventions and medications better than possible with the A1c assay.

Recurrent Endocrine Cycles.

BACKGROUND: The chaotic nature of blood glucose creates a formidable clinical challenge for diabetes healthcare. The recent discovery of recurrent endocrine cycles offers the advantage of advanced-prediction (proactive) health care. METHODS: Historical studies covering 111 patients and 1 subject collected several months of glucose readings and their daily metrics. Phase portraits and phase analytics can detect recurrent metric cycles and test their ability to anticipate serious glycemic conditions. RESULTS: Recurrent patterns were detected having a rate of ~7 days per complete cycle. Plots and risk models based on these cycles produced advanced alerts for acute glycemia, capturing greater than 96% of true-positive days with a 5% false-positive rate. CONCLUSIONS: This method can be implemented graphically and functionally within a BG monitoring system to warn doctors and patients of impending serious glycemic levels.

Robotic objective structured assessment of technical skills: a randomized multicenter dry laboratory training pilot study.

STUDY OBJECTIVE: The goal of this study was to determine if a robotic dry laboratory curriculum for gynecology and urology residents improved their basic robotic skills. METHODS: After the institution-specific institutional review board approval or exemption, 165 residents from 8 gynecology and/or urology programs were enrolled. Residents underwent standardized robotic orientation followed by dry laboratory testing on 4 unique robotic tasks. Residents were block randomized by program to unstructured or structured training programs. Regardless of group, residents were expected to practice for 15 minutes twice monthly over 7 months. Errors, time to completion, and objective structured assessment of technical skills global rating scores were recorded for each task before and after the training period. Statistics were calculated using the Student t tests, Pearson correlation, and analysis of variance with STATA systems (version 11.2). RESULTS: A total of 99 residents completed both the pretraining and posttraining testing. A mean of 4 (range, 0-15) 15-minute training sessions per resident was self-reported. The structured group had faster posttraining times on the transection task, although the unstructured group had higher posttraining scores on the knot-tying task. CONCLUSIONS: Overall, the residents' robotic skills improved after participating in a dry laboratory curriculum; however, robotic availability, duty hour restrictions, and clinical responsibilities limit the curriculum implementation.

Women in Urology 2014.

INTRODUCTION: We reviewed the significance and achievements of female urologists and urological researchers who have impacted the field of urology. METHODS: We reviewed the past and current status of female urologists and researchers in urological investigation. RESULTS: Since 1962, the year that the first woman was board certified as a urologist, the number of women working in urological practice and urological research has steadily increased. As of January 2014 there are 350 female board certified urologists and in tandem a progressive increase in female researchers engaged in urological investigation. Indeed, slightly more than a quarter of urology residents today are women and the match rate is equivalent for men and women seeking a residency slot. Women are beginning to assume leadership positions in academic urology and research environments, working in all areas of the field. CONCLUSIONS: As the number of women urologists and female scientists in urological investigation increased in the last 50 years, their contributions significantly advanced the practice of urology and our understanding of the previously unrecognized causes of urological disease.

Risk factors for urgency incontinence in women undergoing stress urinary incontinence surgery.

Objective. To determine baseline variables associated with urgency urinary incontinence (UUI) in women presenting for stress urinary incontinence (SUI) surgery. Methods. Baseline data from two randomized trials enrolling 1,252 women were analyzed: SISTEr (fascial sling versus Burch colposuspension) and TOMUS (retropubic versus transobturator midurethral sling). Demographic data, POP-Q measures, and validated measures of symptom severity and quality of life were collected. Charlson Comorbidity Index (CCI) and Patient Health Questionnaire-9 were measured in TOMUS. Multivariate models were constructed with UUI and symptom severity as outcomes. Results. Over two-thirds of subjects reported bothersome UUI at baseline. TOMUS patients with more comorbidities had higher UDI irritative scores (CCI score 0 = 39.4, CCI score 1 = 42.1, and CCI score 2+ = 51.0, P = 0.0003), and higher depression scores were associated with more severe UUI. Smoking, parity, prior incontinence surgery/treatment, prolapse stage, and incontinence episode frequency were not independently associated with UUI. Conclusions. There were no modifiable risk factors identified for patient-reported UUI in women presenting for SUI surgery. However, the direct relationships between comorbidity level, depression, and worsening of UUI/urgency symptoms may represent targets for preoperative intervention. Further research is necessary to elucidate the pathophysiologic mechanisms that explain the associations between these medical conditions and bladder function.

Patient satisfaction after midurethral sling surgery for stress urinary incontinence.

OBJECTIVE: To identify factors that may contribute to patient satisfaction with outcome in women who received retropubic and transobturator midurethral slings. METHODS: Satisfaction was assessed 12 months postsurgery as a planned analysis in 597 participants from a multicenter randomized trial comparing retropubic with transobturator midurethral slings using the Incontinence Surgery Satisfaction Questionnaire. Significantly related variables associated with satisfaction in univariable analyses were entered into multivariable logistic regression models to test their independent association with satisfaction. RESULTS: One year after surgery, 264 (88.6%) in the retropubic group and 263 (88.0%) in the transobturator group completed satisfaction questionnaires. Both treatment groups demonstrated a high level of satisfaction with respect to urine leakage (retropubic 85.9% compared with transobturator 90.0%; P=.52), urgency to urinate, frequency of urination, capability of physical activity, social activity, ability to engage in sexual activity, and from an emotional standpoint. Baseline characteristics associated with reduced satisfaction were higher Medical, Epidemiologic, and Social Aspects of Aging Questionnaire urgency subscale scores, detrusor overactivity, and diabetes mellitus. The severity of both objective (frequency of incontinence episodes, pad test weight) and subjective (Incontinence Impact Questionnaire and Urogenital Distress Inventory score) measures of incontinence at baseline and the patients' perceptions of preoperative severity of incontinence and expectations of achieving postoperative cure or improvement were not statistically different between satisfied and unsatisfied patients. In the final multivariable model, satisfaction was associated with overall treatment success (odds ratio [OR] 2.57, 95% confidence interval [CI] 1.29-5.13], greater reduction in Urogenital Distress Inventory (OR 0.97, 95% CI 0.96-0.98) and Incontinence Impact Questionnaire scores (OR 0.99, 95% CI 0.98-0.99), and fewer complications (OR 0.55, 95% CI 0.30-0.99). CONCLUSION: The high level of satisfaction seen after midurethral sling procedures is associated with greater objective and patient-perceived improvement of stress incontinence and fewer complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039. LEVEL OF EVIDENCE: II.

A randomized trial of urodynamic testing before stress-incontinence surgery.

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.).