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.

TikTok misinformation and user engagement in female pelvic floor conditions.

IMPORTANCE: Social media platforms are increasingly utilized to distribute medical information. Our study emphasizes the need for accuracy in pelvic health education on social media and the involvement of female pelvic floor (FPF) specialists in content creation. AIMS: In this cross-sectional study, we assessed the FPF TikTok videos with the highest engagement for quality of information and misinformation and investigated the relationship between misinformation and user engagement. METHODS: We collected all TikTok videos on the US app with hashtags related to FPF conditions, including 76 on pelvic organ prolapse, 323 on urinary tract infection, 84 on overactive bladder, and 972 on incontinence. The top 20 videos for each FPF condition were selected based on highest engagement, and 74 videos total met inclusion criteria. TikTok videos were scored with the validated DISCERN instrument for quality of consumer health information and a 5-point Likert scale for misinformation. The correlation between misinformation and user engagement was assessed. RESULTS: Our analysis revealed positive correlations among higher average misinformation scores and shares (r = 0.37, p < 0.001), likes (r = 0.23, p = 0.004), and overall engagement (r = 0.25, p = 0.002) in FPF TikTok videos as a group, likely driven by the #UTI category. Most TikTok videos (96%) had poor quality of information (DISCERN score < 3), and 18% of TikTok videos contained misinformation. CONCLUSION: The poor quality and prevalence of misinformation in FPF-related TikTok videos with the highest engagement raise concerns about the propagation of nonevidence-based health information.

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.

Development of a tool to assess bladder health knowledge, attitudes, and beliefs (BH-KAB).

INTRODUCTION: Few instruments measure knowledge, attitudes, and beliefs (KAB) related to bladder health. Existing questionnaires have predominantly focused on KAB related to specific conditions such as urinary incontinence, overactive bladder, and other pelvic floor disorders. To address this literature gap, the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium developed an instrument that is being administered in the baseline assessment of the PLUS RISE FOR HEALTH longitudinal study. METHODS: The bladder health knowledge, attitudes, and beliefs (BH-KAB) instrument development process consisted of two phases, item development and evaluation. Item development was guided by a conceptual framework, review of existing KAB instruments, and a review of qualitative data from the PLUS consortium Study of Habits, Attitudes, Realities, and Experiences (SHARE). Evaluation comprised three methods to assess content validity and reduce and refine items: q-sort, e-panel survey, and cognitive interviews. RESULTS: The final 18-item BH-KAB instrument assesses self-reported bladder knowledge; perceptions of bladder function, anatomy, and related medical conditions; attitudes toward different patterns of fluid intake, voiding, and nocturia; the potential to prevent or treat urinary tract infections and incontinence; and the impact of pregnancy and pelvic muscle exercises on bladder health. CONCLUSION: The PLUS BH-KAB instrument may be used independently or in conjunction with other KAB instruments for a more comprehensive assessment of women's KAB related to bladder health. The BH-KAB instrument can inform clinical conversations, health education programming, and research examining potential determinants of bladder health, LUTS, and related behavioral habits (e.g., toileting, fluid intake, pelvic muscle exercises).

Healthy bladder storage and emptying functions in community-dwelling women measured by a 2-day bladder health diary.

INTRODUCTION: The prevalence of healthy bladder storage and emptying function in community-dwelling women is not well established. METHODS: A planned secondary analysis of a US cross-sectional study designed to validate a bladder health instrument was conducted in women aged ≥18 years. A subset was invited to complete the novel 2-day bladder health diary capturing bladder storage and emptying experiences. Overall healthy bladder function was defined as ≤8 waking/daytime voids and ≤1 void during sleeping/nighttime; along with the absence of leakage, urgency, emptying difficulties (initiation, flow, efficacy, relief of urge sensation) and pain. Descriptive statistics of healthy bladder functions and regression models of factors associated with healthy function are reported. RESULTS: Of the 383 invited, 237 (62%) eligible women returned complete dairies. Of these, 12% (29/237) met criteria for overall healthy bladder function. Most (96%) denied pain, 74% had healthy daytime and 83% had healthy nighttime voiding frequency, 64% were continent, 36% reported healthy emptying and 30% denied any urgency episodes. Middle income (odds ratio [OR]:95% confidence interval [CI] = 11.4:1.9-67.4 for $75k-$99 999 vs. $25 000-$49 999), Graduate education (4.8:1.4-17) and previously seeking treatment for bladder problems (OR:95%CI = 0.1; 0-0.9) were associated with overall healthy function. CONCLUSION: The prevalence of overall healthy bladder function was very low based on our strict definition of health as measured on a 2-day diary. However, most women had healthy voiding frequency and denied pain or urinary leakage. Postvoid dribbling and urgency most commonly contributed to an overall unhealthy bladder. Further investigation is needed to determine whether these diary derived measures are meaningful for patient-oriented bladder health research.

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.

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.

A multisite focus group study of US adult women's beliefs and assumptions about bladder health and function.

AIMS: This analysis explored and characterized the ideas adult women have about how the bladder works, the assumptions guiding their bladder-related behaviors, and the beliefs they hold about how their behaviors affect bladder health. METHODS: This was a directed content analysis of qualitative data from the Study of Habits, Attitudes, Realities, and Experiences, a focus group study conducted at seven United States research centers (July 2017 to April 2018). Participants were 316 adult women organized by four age categories (age range: 18-93 years). Analysis and interpretation focused on the "bladder assumptions and beliefs" code using a transdisciplinary lens and inductive approach. RESULTS: During their focus group discourse, participants exhibited a speculative mode of thinking about bladder health and function characterized by uncertainty about how the bladder works. They described the bladder as a mechanism for cleansing the body of impurities, viewing it as part of a larger interconnected bodily system to enable the body to stay healthy. They saw it as susceptible to anatomical changes, such as those related to pregnancy and aging. The women also postulated perceived relationships between bladder function and several health behaviors, including eating healthy foods, staying hydrated, engaging in physical activity and exercise, and adopting specific toileting and hygiene practices. CONCLUSIONS: The findings underscore the importance of guidance from healthcare professionals and systematic community based educational programs for promoting women's understanding about bladder health and empowering them to exert agency to engage in healthy bladder behaviors.

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.

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 ).

Terminology for bladder health research in women and girls: Prevention of Lower Urinary Tract Symptoms transdisciplinary consortium definitions.

AIM: To report research terminology and definitions for describing healthy bladder function among women and girls. METHODS: The Prevention of Lower Urinary tract Symptoms (PLUS) Consortium developed research terminology and definitions for elements of healthy bladder function based on existing understanding of storage and emptying functions of the bladder and accepted definitions of lower urinary tract symptoms (LUTS). The novel concept of a bladder "bioregulatory" function was also proposed. Elements of bladder function corresponding to bladder health (BH) and LUTS were developed and refined using an iterative process. A comprehensive reference table structured by bladder function (Storage, Emptying, and Bioregulatory) and elements of each function was created to document proposed research terminology and definitions. RESULTS: The BH research definitions for each bladder function are: (1) Storage: the ability to hold urine for a reasonable duration of time and sense bladder fullness without fear of or concern about urgency, discomfort or leakage; (2) Emptying: the ability to empty the bladder completely in a timely, efficient, effortless, comfortable manner; and (3) Bioregulatory: the bladder barrier protects the individual/host from pathogens, chemicals, and malignancy. Research definitions for seven Storage, seven Emptying, and three Bioregulatory elements of function are presented. Novel LUTS research definitions were developed when gaps in existing definitions were identified or nonclinical language was desired. CONCLUSIONS: PLUS BH definitions reflect a transdisciplinary approach to standardizing research definitions for elements of bladder function from a perspective of health rather than dysfunction and provide a framework for studying BH in clinical practice, public health promotion, and LUTS prevention.

Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence.

BACKGROUND: Female urinary microbiota are associated with urgency urinary incontinence and response to medication. The urinary microbiota of women with stress urinary incontinence has not been described. OBJECTIVE: We sought to study the cross-sectional relationships between urinary microbiota features and demographic and clinical characteristics of women undergoing stress urinary incontinence surgery. STUDY DESIGN: Preoperative urine specimens were collected from women without urinary tract infection and were available from 197 women (174 voided, 23 catheterized) enrolled in a multicenter prospective randomized trial, the Value of Urodynamic Evaluation study. Demographic and clinical variables were obtained including stress and urgency urinary incontinence symptoms, menopausal status, and hormone use. The bacterial composition of the urine was qualitatively assessed by sequencing the bacterial 16S ribosomal RNA 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 body mass index (P = .02); increased Medical, Epidemiologic, and Social Aspects of Aging urge index score (P = .04); and hormonal status (P < .001). No associations were detected with stress urinary incontinence symptoms. Increased diversity was also associated with a concomitant lower frequency of Lactobacillus in hormone-negative women. CONCLUSION: Women undergoing stress urinary incontinence surgery have detectable urinary microbiota. This cross-sectional analysis revealed that increased diversity of the microbiota was associated with urgency urinary incontinence symptoms, hormonal status, and body mass index. In contrast, the female urinary microbiota were not associated with stress urinary incontinence symptoms.

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.).

5-year longitudinal followup after retropubic and transobturator mid urethral slings.

PURPOSE: Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. MATERIALS AND METHODS: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. RESULTS: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). CONCLUSIONS: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure 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.

Comparison of flowrates and voided volumes during non-instrumented uroflowmetry and pressure-flow studies in women with stress incontinence.

AIMS: The Blaivas-Groutz nomogram defines voiding obstruction in women using Qmax from the NIF and the maximum detrusor pressure (Pdetmax ) from the PFS. The aim of this study was to understand the relationship between NIF and PFS maximum flow rates in women with stress incontinence. METHODS: We analyzed the UDS of 597 women with stress-dominant urinary incontinence. Each subject underwent a NIF and then a PFS. Mixed model was used to test the hypothesis that the relationship between flow rates and voided volume (VV) were similar for NIF and PFS. RESULTS: There were 452 subjects with both NIF and PFS studies that met the inclusion criteria and had max flow rate (Qmax ) for both NIF and PFS. The mean age was 53. Overall, higher VV were observed during PFS compared to NIF and subjects had higher Qmax with NIF compared to PFS. The relationship between Qmax and VV was significantly different between NIF and PFS (P < 0.004). At 200 ml, NIF Qmax was 14% higher than PFS Qmax and this difference increased to 30% at 700 ml. CONCLUSION: The difference between PFS Qmax and NIF Qmax increases as VV increase. As a result, values from PFS and NIF cannot be used interchangeably as has been suggested in the Blaivas-Groutz nomogram for obstruction in women.

Pelvic organ prolapse in a cohort of women treated for stress urinary incontinence.

OBJECTIVE: The aim of our study was to observe pelvic organ prolapse (POP) over time, treated and untreated, in a group of highly characterized women being followed up subjectively and objectively over 5-7 years following continence surgery. STUDY DESIGN: We measured baseline prolapse symptoms and anatomic prolapse in subjects enrolled in the trial of midurethral sling (TOMUS) and E-TOMUS, and measured these same parameters annually for 5-7 years after the index surgery. Additional information about subsequent treatment for POP was also recorded. RESULTS: In all, 597 women were randomized to 1 of 2 midurethral sling procedures in the TOMUS; concomitant vaginal procedures for POP were allowed at the surgeon's discretion. Stage 2 POP was present at baseline in 291 subjects (49%). Symptoms of POP were reported in 67 (25%). Of the asymptomatic women, 34 of 223 (15%) underwent a concomitant POP repair at the time of index sling surgery. Anatomic progression of prolapse in women with asymptomatic, unoperated stage 2 POP over the next 72 months was infrequent and occurred in only 3 of 189 subjects (2%); none underwent surgery for POP. Most symptomatic women (47/67 [70%]) underwent a concomitant repair for POP at the index sling surgery. Three of the 47 women who had undergone concomitant repair for symptomatic stage 2 POP underwent repeat POP surgery (2 at 36 months and 1 at 48 months.) CONCLUSION: For patient populations similar to the TOMUS and E-TOMUS populations, surgeons may counsel women with asymptomatic stage 2 POP that their prolapse is unlikely to require surgery in the next 5-7 years.

Agreement and Reliability of Patient-measured Postvoid Residual Bladder Volumes.

OBJECTIVE: To assess the reliability, agreement with provider measurement, and patient preferences regarding patient self-measurement of postvoid residual bladder volume (PVR). PVR measurement in the nonhealthcare setting is a valuable opportunity for remote monitoring of voiding dysfunction patients. We hypothesized that patient self-measurement of PVR using a smart-device portable ultrasound system with artificial intelligence would demonstrate high reliability, strong agreement with provider measurement, and be preferred over provider measurements. METHODS: Patients were enrolled during outpatient Urology visits. PVRs were measured in triplicate by providers using each of the following: an FDA-cleared (standard) bladder scanner, the portable ultrasound probe using ultrasound images (Butterfly US image mode), and the portable ultrasound probe using abstract images (Butterfly abstract mode). Subjects self-measured PVRs in triplicate using both imaging modes and reported their experiences via questionnaire. Reliability was assessed via intraclass correlation. Agreement between methods was assessed via Bland-Altman analyses using a clinically acceptable difference threshold of 50 mL. RESULTS: Fifty patients were enrolled. Intraclass correlations ranged from 0.95 to 0.98 for each method. 95% limits of agreement between standard bladder scanner and patient self-measurement were - 71.73 mL and 86.73 mL using Butterfly US image mode and - 93.84 mL and 112.52 mL using Butterfly abstract mode, respectively. Most patients preferred self-measurement over provider measurement (74% vs 26%, respectively). CONCLUSION: Patient self-measurement of PVR using smart-device integrated portable ultrasound probes is feasible, reliable, and preferred by patients. Limits of agreement between patient self-measurement and standard bladder scanner measurements exceeded our clinically acceptable difference threshold, though the inherent error of ultrasound-based bladder volume measurements should be considered. Longitudinal PVR assessments in nonhealthcare settings may facilitate remote monitoring of voiding dysfunction patients.

The effect of urodynamic testing on clinical diagnosis, treatment plan and outcomes in women undergoing stress urinary incontinence surgery.

PURPOSE: We evaluated the influence of preoperative urodynamic studies on diagnoses, global treatment plans and outcomes in women treated with surgery for uncomplicated stress predominant urinary incontinence. MATERIALS AND METHODS: We performed a secondary analysis from a multicenter, randomized trial of the value of preoperative urodynamic studies. Physicians provided diagnoses before and after urodynamic studies and global treatment plans, defined as proceeding with surgery, surgery type, surgical modification and nonoperative therapy. Treatment plan changes and surgical outcomes between office evaluation and office evaluation plus urodynamic studies were compared by the McNemar test. RESULTS: Of 315 subjects randomized to urodynamic studies after office evaluation 294 had evaluable data. Urodynamic studies changed the office evaluation diagnoses in 167 women (56.8%), decreasing the diagnoses of overactive bladder-wet (41.6% to 25.2%, p <0.001), overactive bladder-dry (31.4% to 20.8%, p = 0.002) and intrinsic sphincter deficiency (19.4% to 12.6%, p = 0.003) but increasing the diagnosis of voiding dysfunction (2.2% to 11.9%, p <0.001). After urodynamic studies physicians canceled surgery in 4 of 294 women (1.4%), changed the incontinence procedure in 13 (4.4%) and planned to modify mid urethral sling tension (more or less obstructive) in 20 women (6.8%). Nonoperative treatment plans changed in 40 of 294 women (14%). Urodynamic study driven treatment plan changes were not associated with treatment success (OR 0.96, 95% CI 0.41, 2.25, p = 0.92) but they were associated with increased postoperative treatment for urge urinary incontinence (OR 3.23, 95% CI 1.46, 7.14, p = 0.004). CONCLUSIONS: Urodynamic studies significantly changed clinical diagnoses but infrequently changed the global treatment plan or influenced surgeon decision to cancel, change or modify surgical plans. Global treatment plan changes were associated with increased treatment for postoperative urgency urinary incontinence.

The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery.

OBJECTIVE: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure. STUDY DESIGN: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire). RESULTS: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year. CONCLUSION: The PFCS compares favorably to the validated modified Clavien-Dindo instrument.