Purpose: Qualitative studies exploring bladder health are rare compared to research focusing on lower urinary tract symptoms (LUTS). Our aim was to explore adolescent and adult women's perceptions about what constitutes a healthy bladder. Methods: We conducted a 7-site focus group study of bladder health with adolescent and adult women across six age categories (11-14 to 65+ years). Transcripts were analyzed using transdisciplinary, directed content analysis and an iterative interpretive consensus building approach to identify key constructs, focusing on "healthy bladder"and "unhealthy bladder"codes. Results: Forty-four focus groups with 360 participants were completed. Three thematic categories were identified: (1) concept of a healthy bladder (conceptual abstraction); (2) experience of a healthy bladder (subjective experience); and (3) lifestyle and life course considerations (bladder health in context). Participants struggled to define the unfamiliar concept of healthy bladder and relied on contextualized experiences and behaviors for characterizing bladder health. They described the concept of a healthy bladder as something that you did not need to think about but did require attention to healthy habits to maintain. Other features of a healthy bladder discussed include having bladder control despite urgency and environmental constraints on voiding, normal voiding frequency, and qualities of urine and urination. Participants struggled with lack of information about healthy bladder habits and noted absence of routine bladder health screening. Discussion: Findings identify need to promote public education and information sharing in health care visits about bladder health. Further they can inform bladder health promotion and clinical research on LUTS prevention.

Introduction:Women with multiple chronic conditions are more likely than women without them to report lower urinary tract symptoms (LUTS); understanding the association of common and coexisting chronic conditions with bladder health across adulthood may inform prevention efforts. Methods:Data were collected from May 2022 through December 2023 from a regionally representative cohort of community-dwelling adult women in the US. Chronic conditions were assessed by self-report and bladder health, and LUTS were measured using validated questionnaires. Analyses were limited to women aged 40 years or older and included multivariable linear and logistic regression models, adjusted for age, body mass index, physical function, and educational attainment. Results:Of 3,423 eligible participants, 2,016 were aged 40 years or older and responded to questions on multiple chronic conditions. Of these, 449 had no chronic conditions, 405 reported 1 chronic condition, 652 had 2 or 3 chronic conditions, and 510 had 4 or more chronic conditions. Hypertension (41.4%) and osteoarthritis (13.6%) were the most frequently reported coexisting conditions (9.7% had both). Across the 10-item Bladder Health Scales and 6-item Bladder Function Indices, women with 0 or 1 chronic condition reported better bladder health than women with multiple chronic conditions. In this cohort, frequent LUTS did not vary by the number of chronic conditions. Conclusion:The opportunity to promote bladder health among adult women with chronic conditions may precede the development of frequent LUTS. Additional research is needed to determine whether prevention strategies may differ according to common chronic conditions.

Introduction: Toileting behaviors are recognized as potential contributors to lower urinary tract symptoms (LUTS) in women. This study examines the association between toileting behaviors and LUTS among community-dwelling women and whether age modifies these associations. Methods: Cross-sectional analyses were conducted using baseline data from a population-based cohort study, RISE FOR HEALTH (RISE). Women completed validated questionnaires assessing toileting behaviors (Toileting Behaviors-Women's Elimination Behaviors scale) and LUTS (10-item Lower Urinary Tract Dysfunction Research Network-Symptom Index [LURN SI-10]). Toileting behaviors included place preference for voiding, premature voiding, delayed voiding, straining to void, and toileting position. LUTS items included urine storage, emptying, and postmicturition symptoms. Associations were analyzed by proportional odds logistic regression. Analyses were stratified by seven age groupings. Results: Data from 2,327 women (mean age 51.1 years, standard deviation = 18.2) were analyzed. Delayed voiding was most strongly associated with the LURN SI-10 composite score (odds ratio [OR] 1.89; 95% confidence interval [CI]: 1.72, 2.09) and urgency incontinence (OR 1.87; 95% CI: 1.66, 2.10). Premature voiding showed the strongest association with urgency (OR 1.82; 95% CI: 1.68, 2.04). Straining was strongly associated with emptying symptoms, including delay before urine starts (OR 2.28; 95% CI: 2.05, 2.54) and slow stream (OR 2.28; 95% CI: 2.05, 2.53). Age modified associations between delayed voiding and LUTS, with strongest associations among 18- to 25 year-old women. Conclusions: Premature voiding, delayed voiding, and straining showed the strongest associations with LUTS in this cross-sectional analysis. Longitudinal studies are needed to clarify the directionality of these associations. Educating young women on healthy toileting habits may mitigate potential effects of unhealthy toileting behaviors on bladder health.

BACKGROUND:Bladder health encompasses total bladder well-being and not merely the absence of urinary symptoms. While much is known about the prevalence of urinary symptoms in women, little is known about the distribution of bladder health (eg, optimal to poor). OBJECTIVE:We report the distributions of multiple dimensions of bladder health and function in a population-based sample of community-dwelling women, overall and separately in women without urinary symptoms to begin to explore bladder health dimensions that may precede the onset of symptoms. STUDY DESIGN:RISE FOR HEALTH is a regionally-representative cohort study of US women aged 18 and older. Baseline surveys included the validated Bladder Health Scales/Bladder Function Indices, the 10-item Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index, and additional study items. Bladder well-being was assessed across 10 scales and bladder function across 6 indices. Bladder Health Scale scores were adjusted for adaptive/coping behaviors (eg, using/carrying pads, staying close to a toilet) to account for the perceived impact of urinary symptoms on well-being. Scores for scales and indices ranged from 0 (poor well-being/function) to 100 (optimal well-being/function). We calculated summary statistics for each scale (with and without adaptive behavior adjustment) and each index in the full study population and subset of women without urinary symptoms. RESULTS:The mean age of 3027 eligible participants was 49.8 years (standard deviation 17.9). The median global Bladder Health Scale score was 72 (interquartile range: 56, 84) before adjustment for adaptive/coping behaviors and 55 (interquartile range: 34, 78) after adjustment. Median scores for the other scales ranged from 75 to 100 before and 61 to 72 after adjustment. Sixty-nine percent of participants reported using adaptive/coping behaviors, including using pads (40%), toilet mapping (58%), and staying close to a toilet (3%). The median overall Bladder Function Index score was 77 (interquartile range: 63, 89); individual median scores ranged from 63 to 68 for frequency, sensation, continence, and emptying indices to 100 for biosis/urinary tract infection and comfort indices. Among participants without reported urinary symptoms (n=700), scores were higher across all scales (unadjusted medians=88-100 and adjusted medians=82-100) and indices (medians=93-100), indicating better, but not optimal health; however, 38% of asymptomatic women reported using adaptive/coping behaviors: 11% using pads, 30% toilet mapping, and 2% staying close to a toilet. CONCLUSION:We observed a wide range of bladder well-being and function in RISE participants and high utilization of adaptive/coping behaviors. Bladder health variability and utilization of adaptive/coping behaviors was also observed in women without urinary symptoms, highlighting bladder health dimensions not captured by traditional urinary symptom tools and potentially identifying a group of women with "subclinical" symptoms who may be at greater risk of developing urinary symptoms. Future prospective analyses should investigate this novel group of women further.

Mixed urinary incontinence, which includes both stress and urgency urinary incontinence, adversely affects quality of life and can be difficult to manage. Studies comparing procedural-based treatments for mixed urinary incontinence are lacking. To determine whether intradetrusor onabotulinumtoxinA is more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Randomized, superiority trial involving females (aged ≥21 years) with moderate to severe bother from both stress and urgency urinary incontinence who had unsuccessful conservative treatments and oral medications. The study was conducted at 7 US sites with enrollment between July 2020 and September 2022; the last date of follow-up was December 29, 2023. Intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focused on the urgency component), vs surgical synthetic mesh midurethral sling (treatment focused on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between 3 and 6 months. All participants could receive additional treatment (including crossover to the alternative treatment) between 6 and 12 months. The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory (UDI) total score (0-300 points; higher scores indicate worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Among 150 females randomized, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean [SD] age, 59.0 [11.5] years). Both groups demonstrated mean improvement in UDI total score at 6 months with no significant difference between groups (onabotulinumtoxinA: −66.8 points [95% CI, −84.9 to −48.8]; sling: −84.9 [95% CI, −100.5 to −69.3]; mean difference, 18.1 points [95% CI, −4.6 to 40.7]; P = .12). For secondary outcomes, greater UDI stress score improvement was seen with the sling (−45.2 [95% CI, −53.7 to −36.8]) compared with onabotulinumtoxinA (−25.1 [95% CI, −34.1 to −16.1]) (P < .001); however, no significant difference was seen between groups in UDI irritative score (onabotulinumtoxinA: −32.9 [95% CI, −40.3 to −25.6] vs sling: –27.4 [95% CI, −34.6 to −20.3]; P = .27). In the onabotulinumtoxinA group, 12.7% and 28.2% received a second injection by 6 and 12 months, respectively. By 12 months, 30.3% in the sling group received onabotulinumtoxinA, and 15.5% in the onabotulinumtoxinA group received a sling. Overall, adverse events were not different between groups. There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments. These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations. ClinicalTrials.gov Identifier: NCT04171531

Background: To determine the need for an instrument to measure knowledge, attitudes, and beliefs (KAB) regarding bladder health for use in a population-based study of community-dwelling women, we performed a scoping review of the extant literature focusing on studies utilizing survey methodology to characterize bladder health KAB. Objectives: To synthesize quantitative studies on women's KAB regarding bladder health and characterize their survey instruments. Methods: A systematic search in Ovid Medline was conducted for articles published from January 1990 through April 2024. We included quantitative studies that used questionnaires to assess adolescent and adult women's bladder health KAB. Titles, abstracts, and full-text articles were screened, followed by data extraction of key study elements, questionnaire items, and quality. Results: We identified 83 articles across seven topic areas. Studies were conducted in 26 countries in clinically (52%) and community-based (47%) settings. The majority (74%) used cross-sectional designs. Most studies used investigator-designed instruments (n = 36), the Prolapse and Incontinence Knowledge Questionnaire (n = 20), Urinary Incontinence Quiz (n = 6), Knowledge, Attitudes, and Practice (n = 5), and the Urinary Incontinence Knowledge Scale (n = 4). The 33,444 respondents generally had limited knowledge of urinary incontinence. Although awareness of pelvic floor muscle exercises was high, respondents often could not articulate performance or indications. Few studies assessed bladder health and function, and there were limited data on attitudes and beliefs. Conclusions: There is some evidence regarding women's knowledge of bladder and pelvic floor dysfunctions, particularly urinary incontinence, but less is known about women's knowledge of other bladder health topics. Even fewer data exist on bladder health attitudes and beliefs. Survey instruments that comprehensively assess bladder health are needed.

INTRODUCTION:We developed an algorithm-based mobile texting platform for promoting self-management in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). Our aim was to measure the feasibility, usability, and potential utility of the platform. METHODS:A texting platform that delivered 4 treatment modules (education and behavioral modification, cognitive behavioral therapy, pelvic floor physical therapy, and guided mindfulness practices) and an automated weekly message over 6 weeks was developed. Feasibility and usability were determined using patient engagement (proportion of platform messages to which patients responded) and System Usability Scale. Satisfaction with patient-physician communication questionnaire, Pain Self-Efficacy Scale, and Interstitial Cystitis Symptom and Problem Index were administered before and after the intervention. RESULTS:Engagement with the platform in 52 female patients with IC/BPS (median age [IQR] 40 [30-48] years) was 76.9%. The commonest module selected by patients was pelvic floor physical therapy (50%) followed by cognitive behavioral therapy (34%) and guided mindfulness (15%). System usability score (median, IQR) was 87 (83-95), indicating high usability. Satisfaction with patient-physician communication improved significantly (median change, 4; IQR, 1-9; P < .001). Pain self-efficacy score improved from moderate impairment at baseline to minimal impairment at 6 weeks (median change, 10; IQR, 2-18; P < .001). Urinary symptoms scores also improved (median change Interstitial Cystitis Symptom Index, -3; IQR, -5 to -1.5; P < .001, Problem Index, -2; IQR, 5.5 to -0.5; P < .001). CONCLUSIONS:An automated mobile platform has the potential for improving access to self-management strategies and easing clinicians' challenge of counseling patients with IC/BPS during time-limited in-person visits. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT05260112.

The COMPOSUR study is evaluating vibegron for the treatment of overactive bladder (OAB) in a real-world setting. We report results of a prespecified 6-month interim analysis, assessing patient-reported treatment satisfaction, persistence, safety, and tolerability over the first 6 months after receiving a new prescription for vibegron. COMPOSUR (NCT05067478) is a 12-month, phase 4 study of vibegron. Patients were enrolled if they were ≥ 18 years of age with OAB, initiating vibegron after previously receiving anticholinergics (Cohort A) or mirabegron with/without anticholinergics (Cohort B). Satisfaction was assessed via the OAB Satisfaction With Treatment Questionnaire (OAB-SAT-q; domain scores on 0−100 scale, higher scores denoting greater satisfaction). The primary endpoint is the OAB-SAT-q satisfaction domain score. The key secondary endpoints are the percentage of positive responses to OAB-SAT-q questions 1–3 and 11. Additional secondary endpoints include OAB-SAT-q scores for side effects, endorsement, preference, and convenience. Persistence was assessed as an exploratory endpoint. Safety was assessed via adverse events (AEs). A total of 403 patients were enrolled and initiated treatment with vibegron; 104 patients discontinued the study before month 6, most commonly owing to withdrawal of consent (n = 32) and AEs (n = 8). Mean (SD) patient age was 56.1 (12.5) years, and 29

Background/Objectives: We here describe the impact of navigated care on utilization patterns of pharmacologic and minimally invasive overactive bladder therapies. Methods: This retrospective observational cohort study used electronic medical record data from the Precision Point Specialty Analytics Portal in the United States. Eligible patients were adults (≥18 years) newly diagnosed and treated for non-neurogenic overactive bladder (1 January 2015 to 31 December 2019). Categorical endpoints were analyzed by chi-square test or Fisher exact test. Of 170,000 eligible patients, 8982 (≈5%) were randomly selected and stratified by navigation status (navigated: 1150 [12.8%]; non-navigated: 7832 [87.2%]). Results: Overall, 60.0% of patients were female, 69.9% were White, and 42.7% had Medicare coverage. Navigated care was more common among women, Black patients, and those covered by Medicaid/Medicare. Initial pharmacologic treatment rates were similar between navigated and non-navigated groups (anticholinergic: 57.0% vs. 57.4%; beta-3 agonist: 43.0% vs. 42.6%). Greater percentages of navigated versus non-navigated patients received minimally invasive therapy (23.8% vs. 10.8%, respectively; p < 0.0001). Discontinuation rates were lower for navigated versus non-navigated patients undergoing pharmacologic treatment (62.5% vs. 71.3%; p < 0.0001). Conclusions: Patient navigation for overactive bladder may help increase access to minimally invasive therapies and may be a tool to address treatment disparities.

Introduction and HypothesisWomen with vulvovaginal or genital pain more commonly experience interstitial cystitis/bladder pain syndrome (IC/BPS) and urinary tract infections. However, the relationship between genital pain and bladder health is lacking.MethodsWomen in the Prevention of Lower Urinary Tract Symptoms Consortium's RISE FOR HEALTH population-based study answered questions about bladder health globally, and across nine bladder health domains of holding, efficacy, social-occupation, physical activity, intimacy, travel, emotion, perception, and freedom. Bladder function was assessed across six indices including urinary frequency, sensation, continence, comfort, emptying, and dysbiosis (e.g., urinary tract infections). Participants were grouped by no pain beyond transitory events (i.e., minor headaches, toothaches, or sprains), nongenital-related pain only, and any genital pain using a validated pain diagram. Mean adjusted scores and indices were compared using general linear modelling.ResultsOf 1,973 eligible women, 250 (12.7%) reported genital pain, 609 (30.9%) reported nongenital pain only, and 1,114 (56.5%) reported no pain. Women with any genital pain had lower (worse) adjusted mean scores across all bladder health scales (BHS; BHS global adjusted mean 47.5; 95% CI 40.8-54.1), compared with those with nongenital pain only (53.7; 95% CI 47.6-59.8), and no pain (59.3; 95% CI 53.3-65.4). Similarly, adjusted mean total Bladder Functional Index scores were lower for those with genital pain (63.1; 95% CI 58.4-67.9) compared with nongenital pain (72.1; 95% CI 67.7-76.5) and no pain (77.4; 95% CI 73.0-81.8).ConclusionsHeightened awareness of the relationship between genital pain and bladder health should prompt clinicians caring for women with genital pain to assess bladder health and function.

PURPOSE:This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM).MATERIALS AND METHODS:A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined.RESULTS:A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability.CONCLUSIONS:PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.

Urgency urinary incontinence (UUI), a risk factor for falls, affects 40

Overactive bladder (OAB) is a prevalent condition that impairs the quality of life in both men and women, and for many, urgency is the most bothersome symptom. Urgency is thought to drive the presentation of the other symptoms (frequency, nocturia, urgency urinary incontinence [UUI]). However, urgency has been understudied in clinical trials, potentially owing to inherent difficulties in its assessment. The definition of urgency related to OAB has been refined over the years, but it may not be easily understood by patients and clinicians, affecting its use in practice. Variability among the tools to measure urgency further complicates the matter. For example, some measure the frequency of urgency episodes and consider reduction of episode frequency as improvement in urgency severity. Others rate the severity of each episode of urgency along a scale, with some including an accompanying incontinence episode as the most severe form. Reduction in UUI episodes is often a primary endpoint in clinical studies, with many studies requiring UUI—sometimes called OAB-wet—as an inclusion criterion, yet approximately two-thirds of those with OAB do not experience UUI. If patients with OAB without UUI (i.e., OAB-dry) are included, they are often not analyzed separately. Thus, it remains unknown if there are differences in treatment outcomes between patients with and without UUI and whether these differences are driven by pathophysiological processes. This narrative review highlights what is known about the pathophysiology of urgency, how urgency affects individuals with OAB, urgency measurement and associated challenges, and assessment of urgency in clinical trials.

ABSTRACTIntroductionUroflowmetry is often used to assess lower urinary tract symptoms (LUTS). Criteria for characterization of flow patterns are not well established, and subjective interpretation is the most common approach for flow curve classification. We assessed the reliability of uroflowmetry curve interpretation in adult women.Materials and MethodsUroflowmetry studies were obtained in 296 women who participated in an observational cohort study. Four investigators with expertise in female LUTS and urodynamics reviewed and categorized each tracing for interrater reliability. A random subset of 50 tracings was re‐reviewed by each investigator for intrarater reliability. The uroflowmetry tracings were rated using categories of continuous, continuous fluctuating, interrupted, and prolonged. Other parameters included flow rate, voided volume, time to maximum flow, and voiding time. Agreement between raters is summarized with kappa (k) statistics and percentage where at least three raters agreed.ResultsThe mean age of participants was 44.8 ± 18.3 years. Participant age categories were 18–24 years: 20%; 25–34 years: 17%; 35–64 years: 42%; 65+ years: 18%. Nine percent described their race as Asian, 31% Black, 62% White, and 89% were of non‐Hispanic ethnicity. The interrater reliability was highest for the continuous flow category (k = 0.65), 0.47 for prolonged, 0.41 for continuous fluctuating, and 0.39 for interrupted flow curves. Agreement among at least three raters occurred in 74.3% of uroflow curves (69% for continuous, 33% for continuous fluctuating, 23% for interrupted, and 25% for prolonged). For intrarater reliability, the mean k was 0.72 with a range of 0.57–0.85.ConclusionsCurrently accepted uroflowmetry pattern categories have fair to moderate interrater reliability, which is lower for flow curves that do not meet “continuous” criteria. Given the subjective nature of interpreting uroflowmetry data, more consistent and clear parameters may enhance reliability for use in research and as a screening tool for LUTS and voiding dysfunction.Trial RegistrationParent trial: Validation of Bladder Health Instrument for Evaluation in Women (VIEW); ClinicalTrials.gov ID: NCT04016298.