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.

Comprehensive pelvic muscle assessment: Developing and testing a dual e-Learning and simulation-based training program.

OBJECTIVE: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium launched the RISE FOR HEALTH (RISE) national study of women's bladder health which includes annual surveys and an in-person visit. For the in-person exam, a standardized, replicable approach to conducting a pelvic muscle (PM) assessment was necessary. The process used to develop the training, the products, and group testing results from the education and training are described. METHODS: A comprehensive pelvic muscle assessment (CPMA) program was informed by literature view and expert opinion. Training materials were prepared for use on an electronicLearning (e-Learning) platform. An in-person hands-on simulation and certification session was then designed. It included a performance checklist assessment for use by Clinical Trainers, who in collaboration with a gynecology teaching assistant, provided an audit and feedback process to determine Trainee competency. RESULTS: Five discrete components for CPMA training were developed as e-Learning modules. These were: (1) overview of all the clinical measures and PM anatomy and examination assessments, (2) visual assessment for pronounced pelvic organ prolapse, (3) palpatory assessment of the pubovisceral muscle to estimate muscle integrity, (4) digital vaginal assessment to estimate strength, duration, symmetry during PM contraction, and (5) pressure palpation of both myofascial structures and PMs to assess for self-report of pain. Seventeen Trainees completed the full CPMA training, all successfully meeting the a priori certification required pass rate of 85% on checklist assessment. CONCLUSIONS: The RISE CPMA training program was successfully conducted to assure standardization of the PM assessment across the PLUS multicenter research sites. This approach can be used by researchers and healthcare professionals who desire a standardized approach to assess competency when performing this CPMA in the clinical or research setting.

The RISE FOR HEALTH study: Methods for in-person assessment and biospecimen collection.

OBJECTIVES: To describe the methods for the in-person assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors that promote bladder health and/or prevent lower urinary tract symptoms in adult women, conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS AND RESULTS: A subset of RISE participants who express interest in the in-person assessment will be screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete 15 physical assessments in addition to height and weight, to assess pelvic floor muscle function, musculoskeletal (MSK) status, and pain, and to provide urogenital microbiome samples. Pelvic floor muscle assessments include presence of prolapse, strength, levator attachment integrity (tear) and myofascial pain. MSK tests evaluate core stability, lumbar spine, pelvic girdle and hip pain and function. Participants are asked to complete the Short Physical Performance Battery to measure balance, lower extremity strength, and functional capacity. All participants are asked to provide a voided urine sample and a vaginal swab for microbiome analyses; a subset of 100 are asked to contribute additional samples for feasibility and validation of a home collection of urinary, vaginal, and fecal biospecimens. RESULTS: Online and in-person training sessions were used to certify research staff at each clinical center before the start of RISE in-person assessments. Standardized protocols and data collection methods are employed uniformly across sites. CONCLUSIONS: The RISE in-person assessment is an integral portion of the overall population-based RISE study and represents an innovative approach to assessing factors hypothesized to promote bladder health and/or prevent lower urinary tract symptoms. Data collected from this assessment will be used to prioritize future research questions and prevention strategies and interventions. This description of the assessment methods is intended to provide methodologic transparency and inform other researchers who join efforts to understand and improve bladder health.

Fluids affecting bladder urgency and lower urinary symptoms: results from a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Caffeinated, alcoholic, artificially sweetened, carbonated, and acidic beverages are pervasive and consumed in large quantities. Reputedly, these beverages are "irritating to the bladder" and result in heightened void frequency, but prior studies lack control for intake volume. We tested the null hypothesis that women recruited from the community who demonstrate overactive bladder symptoms will show no difference by groups in void frequency when one group is instructed to replace listed beverages by substituting non-irritants (emphasis on water or milk) and the other group is instructed in healthy eating. METHODS: This was a parallel-group randomized controlled trial design with a three-period fixed sequence (baseline and 2 and 6 weeks post-baseline). We recruited 105 community women with overactive bladder symptoms. INCLUSION CRITERIA: >7 voids per day or 2 voids per night, daily intake of ≥16 oz. (473 ml) of beverages containing the ingredients listed above, and ≥ 32 oz. (946 ml) of total fluid intake. Stratified randomization was conducted. The primary outcome was average daily void frequency on a 3-day diary. RESULTS: Participants were 86% white, mean (SD) age was 46.6 (17.6) years, and baseline void frequency was 9.2 (2.9) voids per day. At 2 and 6 weeks, estimated average (SD) difference in void frequency between group 1 and group 2 was -0.46 (0.57) and -0.31 (0.57) voids per day (p > 0.05); the null hypothesis was not rejected. CONCLUSIONS: Women who reduce potentially irritating beverages while maintaining total fluid volume intake is not predictive of void frequency. Further research on type and volume of beverage intake is recommended.

Mechanisms of pelvic floor muscle training for managing urinary incontinence in women: a scoping review.

BACKGROUND: Pelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms: 'Enhanced Pelvic Floor Muscle Strength,' 'Maximized Awareness of Timing,' and 'Strengthened Core Muscles'. The purpose of this scoping review was to systematically map evidence for and against theorized mechanisms through which pelvic floor muscle training interventions work to reduce urinary incontinence in women. METHODS: The scoping review is based upon a comprehensive search of relevant literature published from 1990 to 2020 in PubMed, CINAHL, PsycINFO, ClinialTrials.gov, reference lists from review articles, and hand searches of articles by known researchers in the field. We included English-language, peer-reviewed articles on pelvic floor muscle training as an intervention for adult women if they provided empirical evidence to testing the theorized intervention mechanisms. Two independent reviewers screened articles for inclusion and extracted data to describe details of each study (author, year, country, design, sampling), measures of pelvic floor muscle strength and urinary incontinence, statistical analysis of linkage between changes in the measures, and pelvic floor muscle training regimens. Data were summarized to facilitate the integration of diverse evidence to draw conclusions on supporting or refuting the three proposed theorized mechanisms for managing urinary incontinence in women. RESULTS: Of the 278 articles identified with the search, 13 (4.7%) met inclusion criteria. There was weak to no evidence for the mechanism of enhanced pelvic floor muscle strength, equivocal support for maximized awareness of timing, and no evidence for strengthened core muscles. CONCLUSIONS: This review revealed extremely limited data supporting the proposed theorized mechanisms underlying pelvic floor muscle training programs to manage urinary incontinence in women. Such evidence is needed to help women and clinicians understand how, why and when a woman benefits from pelvic floor muscle training. Future studies should specifically state and report statistical analysis that relates the theorized mechanisms to the training outcomes observed.

A feasibility study of virtual group therapy to improve quality of life of cancer caregivers.

BACKGROUND: Cancer caregiving can negatively impact the quality of life (QOL) of the caregiver. In-person interventions for improving coping skills have been shown to be effective in improving QOL for caregivers. OBJECTIVES: This pilot project explored the feasibility and acceptability of a virtual group therapy intervention to improve short-term cancer caregiver QOL. METHODS: Caregivers of cancer patients were enrolled in a structured multidisciplinary intervention of eight virtual group therapy sessions provided over four weeks between September 9, 2013 and November 17, 2014. Group sessions were led by trained facilitators and included components of physical therapy, occupational therapy, psychosocial education, cognitive-behavioral intervention, supportive discussion, spiritual reflection, and mindfulness therapy. Feasibility was based on acceptable number of recruited participants per session; acceptability was defined using attendance and 80% QOL completion rates. QOL domains and symptom burden were assessed using validated single items. RESULTS: The 20 cancer caregivers who enrolled were mostly older (80% were ≥ 65 years), female (76.5%), married to the patient (88.2%), Caucasian (100%), and highly educated (100%). 60% attended one to five sessions, 15% attended six to eight sessions, and 25% attended no sessions. Thirty percent completed pre- and post- intervention ratings of QOL items. SIGNIFICANCE OF RESULTS: Findings suggested that a virtual group therapy intervention is feasible for the cancer caregivers in this study. Although not statistically significant, the caregivers reported higher QOL and less symptom burden in multiple domains after participating in the virtual group therapy intervention.

Paper towel test as independently self-administered to quantify cough-related urine loss: Compliance and comparisons with survey-only data in SWAN.

AIMS: The epidemiologic Study of Women's Health Across the Nation (SWAN) includes urinary incontinence (UI) questionnaire items. We introduced an independently self-administered paper towel test (PTT-ISA; invention disclosure #2021-347) to objectively demonstrate UI. Aims were to determine: (1) PTT-ISA compliance and (2) relationship to questionnaire results. METHODS: 276 community women were invited to complete both SWAN questionnaire and PTT-ISA. For PTT-ISA, a woman holds a trifold brown paper towel against her perineum while coughing hard three times. She checks the towel for wetness and compares it with pictorial showing wetted area gradations (dry towel through >6 ml/saturated). She then selects the best photo match for her towel. A newly conceptualized variable constructed as PTT-ISA plus questionnaire results was formed. RESULTS: Of 276 women, noncompliance with PTT-ISA was 2.2% (6 women). Four others (1.5%) were missing questionnaires. For the remaining 266 women, conceptual cohesiveness between questionnaire-only and PTT-ISA + questionnaire was demonstrated in 165 (62.0%). Lack of cohesiveness occurred in 101 (38.9%), including 41 women who said "no" to the questionnaire item indicative of stress UI and had leakage on PTT-ISA; leakage degree varied across the full pictorial spectrum from drops to saturated. CONCLUSION: PTT-ISA demonstrates high compliance, with rate comparable to survey compliance. It is a novel measure for objective sign of urine loss when independently self-administered by community women outside of a clinic environment. Further research comparing PTT-ISA with clinician-observed cough test is warranted. As independently self-administered, PTT-ISA is simple, noninvasive, inexpensive, and an acceptable test that adds value to otherwise survey-dependent research.

Association of pubovisceral muscle tear with functional capacity of urethral closure: evaluating maternal recovery from labor and delivery.

BACKGROUND: Vaginal birth is a risk factor for pubovisceral muscle tear, decreased urethral closure pressure, and urinary incontinence. The relationship between these 3 factors is complicated. Urinary continence relies on maintaining urethral closure pressure, particularly when low urethral closure pressure can usefully be augmented by a volitional pelvic muscle (Kegel) contraction just before and during stress events like a cough. However, it is unknown whether a torn pubovisceral muscle decreases the ability to increase urethral closure during an attempted pelvic muscle contraction. OBJECTIVE: We tested the null hypothesis that a pubovisceral muscle tear does not affect the ability to increase urethral closure pressure during a volitional pelvic muscle contraction in the Evaluating Maternal Recovery from Labor and Delivery (EMRLD) study. STUDY DESIGN: We studied 56 women 8 months after their first vaginal birth. All had at least 1 risk factor for pubovisceral muscle tear (eg, forceps and long second stage). A tear was assessed bilaterally by magnetic resonance imaging. Urethral closure pressure was measured both at rest and during an attempted volitional pelvic muscle contraction. A Student t test was used to compare urethral closure pressures. Multiple linear regression was used to estimate the effect of a magnetic resonance imaging-confirmed pubovisceral muscle tear on volitionally contracted urethral closure pressure after adjusting for resting urethral closure pressure. RESULTS: The mean age was just a little more than 30 years, with the majority being white. By magnetic resonance imaging measure, unadjusted for other factors, the 21 women with tear had significantly lower urethral closure pressure during an attempted contraction compared with the 35 women without tear (65.9 vs 86.8 cm H2O, respectively, P = .004), leading us to reject the null hypothesis. No significant group difference was found in resting urethral closure pressure. After adjusting for resting urethral closure pressure, pubovisceral muscle tear was associated with lower urethral closure pressure (beta = -21.1, P = .001). CONCLUSION: In the first postpartum year, the presence of a pubovisceral muscle tear did not influence resting urethral closure. However, women with a pubovisceral muscle tear achieved a 25% lower urethral closure pressure during an attempted pelvic muscle contraction than those without a pubovisceral muscle tear. These women with pubovisceral muscle tear may not respond to classic behavioral interventions, such as squeeze when you sneeze or strengthen through repetitive pelvic muscle exercises. When a rapid rise to maximum urethral pressure is used as a conscious volitional maneuver, it appears to be reliant on the ability to recruit the intact pubovisceral muscle to simultaneously contract the urethral striated muscle.

Is the juice worth the squeeze? Transdisciplinary team science in bladder health.

AIMS: Prior research on lower urinary tract symptoms (LUTS) has focused on the treatment and management of these conditions with scant attention to prevention. The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was formed to address the complexities of preventing LUTS and promoting bladder health. METHODS: Herein, we describe challenges faced and strategies used to develop the PLUS Research Consortium into an engaged and productive transdisciplinary scientific team. We apply four previously defined team science phases (development, conceptualization, implementation, and translation) to frame our progress. RESULTS: Strategies to progress through the development phase included the generation of a shared mission, and valuing of other disciplinary perspectives. The conceptualization phase included generating a shared language and developing a team transdisciplinary orientation. During the implementation phase, the group developed roles and procedures and focused on conflict management. The translation phase includes continued refinement of the mission and goals, implementation of research protocols, and robust dissemination of the scientific work products related to bladder health. CONCLUSION: A diverse group has matured into a productive transdisciplinary team science consortium. Achieving this outcome required dedicated effort for each member to engage in activities that often required more time than single discipline research activities. Provision of the necessary time and tools has fostered a transdisciplinary team science culture and rich research agenda that reflects the complexity of the health issue to be addressed. Our experience may be useful for others embarking on team science projects.

Fluids affecting bladder urgency and lower urinary symptoms (FABULUS): methods and protocol for a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: We present the design of a randomized controlled trial, Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS), with the purpose of testing the common clinical advice of treating overactive bladder by eliminating potentially irritating beverages (PIBs) that are caffeinated, artificially sweetened, citric, or alcoholic. The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations. Secondary outcomes include change in urgency symptoms and volume per void. METHODS: We report the methods for FABULUS and discuss how challenges presented in the literature and from a prior proof-of-concept feasibility trial are addressed by strengthening study design, procedures, and instruments. We introduce the concept of standardized automated tutorials for assisting participants in compliance from study start to finish. The tutorials contain a detailed explanation of the study, including tips for complying with the extensive diary requirements, and parallel tutorials to intervention and control groups for consistency in format and time of instructional content. The intervention tutorial on eliminating PIBs places emphasis on maintaining steady fluid intake volume, as fluctuations have been a confounder in prior work. RESULTS: Study results promise to inform about both the tutorial approach and specific PIB reduction for effectively treating overactive bladder. CONCLUSIONS: OAB can have a negative impact on quality of life, and current medical treatments carry costs and side-effect risks. If simple lifestyle changes can improve or prevent these bladder symptoms, multiple medical and public health advances could result.

Association of index finger palpatory assessment of pubovisceral muscle body integrity with MRI-documented tear.

AIMS: Pubovisceral (PV) muscle tears are associated with pelvic floor disorders. The goal of this study was to determine whether index finger palpatory assessment of PV muscle body integrity through the lateral vaginal wall is a reliable indicator of PV muscle tear severity diagnosed by magnetic resonance imaging (MRI). METHODS: We studied 85 women, 7 weeks after vaginal birth. All had at least one risk factor for obstetric-related PV muscle tear. The ordinal outcome measure of MRI-documented PV muscle tear was defined as: none, less than 50% unilateral tear, 50% or greater unilateral tear or less than 50% bilateral tear, and 50% or greater bilateral tear. PV muscle body integrity by palpatory assessment was scored on a matrix, with each side scored independently and classified as PV muscle body "present" (assuredly felt), "equivocal" (not sure if felt), or "absent" (assuredly not felt). Proportional odds models were constructed to estimate the relationship between PV muscle body integrity palpatory assessment and MRI-documented PV muscle tears. RESULTS: Thirty-five percent of study participants exhibited varying degrees of MRI-documented PV muscle tears. Using palpatory assessment, we identified "PV muscle body present bilaterally" in 20%, "equivocal unilaterally or present contralaterally" in 8%, "equivocal or absent unilaterally" or "equivocal bilaterally" in 62%, and "absent bilaterally" in 9%. The odds ratio for estimating MRI results from palpatory assessment was 3.62 (95% confidence interval = 1.70-7.73, P = 0.001). CONCLUSIONS: A rapid and inexpensive palpatory assessment in the clinic was highly associated with the risk of MRI-documented PV muscle tear and is a useful component of a clinical assessment.

A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study.

PURPOSE: We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. MATERIALS AND METHODS: A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. RESULTS: A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. CONCLUSIONS: The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women.

Impact of Dry Mouth on Fluid Intake and Overactive Bladder Symptoms in Women taking Fesoterodine.

PURPOSE: We investigated the long-term relationships between dry mouth, fluid intake and overactive bladder symptoms in women undergoing treatment with fesoterodine. We hypothesized that women who experienced dry mouth would increase their fluid intake and worsen their urinary symptoms. MATERIALS AND METHODS: We conducted a prospective ancillary study to a 9-month open-label trial of fesoterodine for women with urgency urinary incontinence. Fluid intake was measured and compared according to reported dry mouth. Multivariable analysis was used to study the interaction between dry mouth, fluid intake and urinary symptoms. RESULTS: During the study 407 women without dry mouth significantly reduced their fluid intake (mean decrease 172.1 ml, median 118.3 ml, p = 0.02), while 91 women with dry mouth did not (mean decrease 95.8 ml, median 118.3 ml, p = 0.54). On univariable analysis a greater proportion of women who experienced dry mouth reported improvement in their urinary symptoms compared to women without dry mouth (60.5% vs 47.2%, p = 0.03). On multivariable analysis black women were less likely to report dry mouth (OR 0.4, 95% CI 0.2-0.9, p = 0.03) and older women were less likely to report improvement in urinary symptoms (OR 0.98, 95% CI 0.96-0.99, p = 0.003). Factors not associated with improvement in urinary symptoms on multiple regression were dry mouth, baseline fluid intake volume, change in fluid intake volume and caffeine intake volume. CONCLUSIONS: In women with overactive bladder receiving fesoterodine dry mouth may prevent restriction of fluid intake but does not diminish treatment efficacy.

Does Instruction to Eliminate Coffee, Tea, Alcohol, Carbonated, and Artificially Sweetened Beverages Improve Lower Urinary Tract Symptoms?: A Prospective Trial.

PURPOSE: Common advice for lower urinary tract symptoms (LUTS) such as frequency, urgency, and related bother includes elimination of potentially irritating beverages (coffee, tea, alcohol, and carbonated and/or artificially sweetened beverages). The purpose of this study was to determine compliance with standardized instruction to eliminate these potentially irritating beverages, whether LUTS improved after instruction, and whether symptoms worsened with partial reintroduction. DESIGN: The 3-phase fixed sequence design was (1) baseline, (2) eliminate potentially irritating beverages listed above, and (3) reintroduce at 50% of baseline volume, with a washout period between each 3-day phase. We asked participants to maintain total intake volume by swapping in equal amounts of nonpotentially irritating beverages (primarily water). SUBJECTS AND SETTING: The study sample comprised 30 community-dwelling women recruited through newspaper advertisement. METHODS: Quantification measures included 3-day voiding diaries and detailed beverage intake, and LUTS questionnaires completed during each phase. RESULTS: During Phase 2, we found significant reduction in potentially irritating beverages but complete elimination was rare. Despite protocol demands, total beverage intake was not stable; mean (± standard deviation) daily total intake volume dropped by 6.2 ± 14.9 oz (P = .03) during Phase 2. In Phase 3, the volume of total beverage intake returned to baseline, but the intake of potentially irritating beverages also returned to near baseline rather than 50% as requested by protocol. Despite this incomplete adherence to study protocols, women reported reduction in symptoms of urge, inability to delay voiding, and bother during both phases (P ≤ .01). The number of voids per day decreased on average by 1.3 and 0.9 voids during Phases 2 and 3, respectively (P = .002 and P = .035). CONCLUSIONS: Education to reduce potentially irritating beverages resulted in improvement in LUTS. However, eliminating potentially irritating beverages was difficult to achieve and maintain. Study findings do not allow us to determine whether LUTS improvement was attributable to intake of fewer potentially irritating beverages, reduced intake of all beverages, the effect of self-monitoring, or some combination of these factors.

Evaluating maternal recovery from labor and delivery: bone and levator ani injuries.

OBJECTIVE: We sought to describe occurrence, recovery, and consequences of musculoskeletal (MSK) injuries in women at risk for childbirth-related pelvic floor injury at first vaginal birth. STUDY DESIGN: Evaluating Maternal Recovery from Labor and Delivery is a longitudinal cohort design study of women recruited early postbirth and followed over time. We report here on 68 women who had birth-related risk factors for levator ani (LA) muscle injury, including long second stage, anal tears, and/or older maternal age, and who were evaluated by MSK magnetic resonance imaging at both 7 weeks and 8 months' postpartum. We categorized magnitude of injury by extent of bone marrow edema, pubic bone fracture, LA muscle edema, and LA muscle tear. We also measured the force of LA muscle contraction, urethral pressure, pelvic organ prolapse, and incontinence. RESULTS: In this higher-risk sample, 66% (39/59) had pubic bone marrow edema, 29% (17/59) had subcortical fracture, 90% (53/59) had LA muscle edema, and 41% (28/68) had low-grade or greater LA tear 7 weeks' postpartum. The magnitude of LA muscle tear did not substantially change by 8 months' postpartum (P = .86), but LA muscle edema and bone injuries showed total or near total resolution (P < .05). The magnitude of unresolved MSK injuries correlated with magnitude of reduced LA muscle force and posterior vaginal wall descent (P < .05) but not with urethral pressure, volume of demonstrable stress incontinence, or self-report of incontinence severity (P > .05). CONCLUSION: Pubic bone edema and subcortical fracture and LA muscle injury are common when studied in women with certain risk factors. The bony abnormalities resolve, but levator tear does not, and is associated with levator weakness and posterior-vaginal wall descent.

Comparison of muscle fiber directions between different levator ani muscle subdivisions: in vivo MRI measurements in women.

INTRODUCTION AND HYPOTHESIS: This study describes a technique to quantify muscle fascicle directions in the levator ani (LA) and tests the null hypothesis that the in vivo fascicle directions for each LA subdivision subtend the same parasagittal angle relative to a horizontal reference axis. METHODS: Visible muscle fascicle direction in the each of the three LA muscle subdivisions, the pubovisceral (PVM; synonymous with pubococcygeal), puborectal (PRM), and iliococcygeal (ICM) muscles, as well as the external anal sphincter (EAS), were measured on 3-T sagittal MRI images in a convenience sample of 14 healthy women in whom muscle fascicles were visible. Mean ± standard deviation (SD) angle values relative to the horizontal were calculated for each muscle subdivision. Repeated measures ANOVA and post-hoc paired t tests were used to compare muscle groups. RESULTS: Pubovisceral muscle fiber inclination was 41 ± 8.0°, PRM was -19 ± 10.1°, ICM was 33 ± 8.8°, and EAS was -43 ± 6.4°. These fascicle directions were statistically different (p < 0.001). Pairwise comparisons among levator subdivisions showed angle differences of 60° between PVM and PRM, and 52° between ICM and PRM. An 84° difference existed between PVM and EAS. The smallest angle difference between levator divisions was between PVM and ICM 8°. The difference between PRM and EAS was 24°. All pairwise comparisons were significant (p < 0.001). CONCLUSIONS: The null hypothesis that muscle fascicle inclinations are similar in the three subdivisions of the levator ani and the external anal sphincter was rejected. The largest difference in levator subdivision inclination, 60°, was found between the PVM and PRM.

Race/Ethnicity and Incidence of Pelvic Organ Prolapse in Midlife Women: The Study of Women's Health Across the Nation.

Background: Pelvic organ prolapse (POP) affects a considerable proportion of women. Limited information exists regarding the incidence of POP as women transition through menopause. Using data from the Study of Women's Health Across the Nation (SWAN), this diverse community-based longitudinal cohort study assessed the incidence of symptomatic POP and risk by race/ethnicity. Methods: Self-reported POP was ascertained by questionnaire at 11 approximately annual SWAN visits over a median of 13.3 years of follow-up. We estimated probabilities for reporting POP using interval-censored Kaplan-Meier survival plots. We estimated hazard ratios (HR) and 95% confidence intervals (CI) using interval-censored Cox proportional hazards models. Results: The estimated cumulative probability of POP increased linearly from 2.1% at age 45 to 10.1% by age 65 (4.0% per decade). At age 65, the probability was 4.2%, 4.8%, 8.9%, 9.7%, and 33.9% for Japanese, Chinese, Black, White, and Hispanic women, respectively. Compared with White women, the unadjusted HR for POP was 3.09 (95% CI = 2.18-4.39), 0.96 (0.71-1.31), 0.43 (0.22-0.85), and 0.48 (0.26-0.88) for Hispanic, Black, Chinese, and Japanese women, respectively. After adjustment for financial strain and vaginal birth, the low hazards among Chinese and Japanese women and the high hazard for Hispanic women remained significant. Conclusion: Incidence of symptomatic POP increased as women aged through midlife. Risks varied by race and ethnicity and were not accounted for by population differences in socioeconomic life contexts or the probability of having had a vaginal birth. Although not associated with menopause, health providers should incorporate screening for and information about POP when treating menopausal symptoms and health needs of midlife women. Research on pathophysiological factors associated with increasing POP in midlife is warranted.

Design of a Tool Capable of Assessing Environmental Sociocultural Physical Factors Influencing Women's Decisions on When and Where to Toilet Within Real-World Settings: Protocol for the Build and Usability Testing of a Mobile App for Use by Community-Dwelling Women.

BACKGROUND: Although surveys and apps are available for women to report urination and bladder symptoms, they do not include their decisions regarding toileting. Real-world factors can interfere with toileting decisions, which may then influence bladder health. This premise lacks data per want of a robust data collection tool. OBJECTIVE: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium engaged a transdisciplinary team to build and test WhereIGo, a mobile data collection app for Android and iOS. The design goal was a comprehensive reporting system for capturing environmental, sociocultural, and physical factors that influence women's decisions for toileting. Aims include having (1) an innovative feature for reporting physiologic urge sensation when "thinking about my bladder" and shortly before "I just peed," (2) real-time reporting along with short look-back opportunities, and (3) ease of use anywhere. METHODS: The development team included a plain language specialist, a usability specialist, creative designers, programming experts, and PLUS scientific content experts. Both real-time and ecological momentary assessments were used to comprehensively capture influences on toileting decisions including perceived access to toileting, degree of busyness or stress or focus, beverage intake amount, urge degree, or a leakage event. The restriction on the maximal number of taps for any screen was six. PLUS consortium investigators did pilot-testing. Formal usability testing relied on the recruitment of community-dwelling women at four PLUS research sites. Women used the app for 2 consecutive days. Outcome measures were the system usability scale (SUS; 0-100 range) and the functional Mobile Application Rating Scale (1-5 range). These scales were embedded at the end of the app. The estimated a priori sample size needed, considering the SUS cut point score set at ≥74, was 40 women completing the study. RESULTS: Funding was provided by the National Institute of Diabetes and Digestive and Kidney Diseases since July 2015. The integrity of the build process was documented through multiple 5-minute videos presented to PLUS Consortium and through WhereIGo screenshots of the final product. Participants included 44 women, with 41 (93%) completing data collection. Participants ranged in age from 21 to 85 years, were predominantly non-Hispanic White (n=25, 57%), college-educated (n=25, 57%), and with incomes below US $75,000 (n=27, 62%). The SUS score was 78.0 (SE 1.7), which was higher than 75% of the 500 products tested by the SUS developers. The mean functional Mobile Application Rating Scale score was 4.4 (SE 0.08). The build and informal acceptability testing were completed in 2019, enrollment for formal usability testing completed by June 2020, and analysis was completed in 2022. CONCLUSIONS: WhereIGo is a novel app with good usability for women to report toileting decisions, urination, and fluid intake. Future research using the app could test the influence of real-time factors on bladder health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/54046.

Randomized controlled trial of maintaining quality of life during radiotherapy for advanced cancer.

BACKGROUND: Psychosocial interventions often address only 1 domain of quality of life (QOL), are offered to patients with early-stage cancer, do not include the caregiver, and are delivered after cancer treatment has been completed. METHODS: In the current randomized controlled trial, 131 patients with advanced cancer who received radiotherapy and their caregivers were randomly assigned to either a 6-session, structured, multidisciplinary intervention arm or a standard care arm. The average age of the patients was 58 years, the majority were male (63%), and tumor types varied (gastrointestinal [37%], brain [22%], head and neck [16%], lung [13%], and other [12%]). The six 90-minute sessions addressed the 5 domains of QOL: cognitive, physical, emotional, social, and spiritual. The in-person intervention was followed by 10 brief telephone counseling sessions that took place over the next 6 months. RESULTS: Of the 117 patients who completed the study, overall QOL (assessed by Functional Assessment of Cancer Therapy-General [FACT-G]) at week 4 was significantly higher in the intervention group (n = 54) compared with the standard arm control group (n = 63) (75.2 vs 68.7; P = .02). The 10 brief telephone contacts did not appear to impact QOL because at week 27 the groups had identical QOL (means of 77.6 and 77.7, respectively). There was no effect of the intervention noted on caregiver QOL. CONCLUSIONS: Participating in a 6-session multidisciplinary intervention was found to be effective in maintaining the QOL of patients with advanced cancer who were actively receiving radiotherapy. The QOL and symptom burden of this population is striking, making it important to identify effective QOL strategies to implement in conjunction with cancer care.

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial.

INTRODUCTION AND HYPOTHESIS: The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. METHODS: This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. RESULTS: No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value = 0.57) or in combination with prenatal perineal massage (P value = 0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. CONCLUSIONS: Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups.