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.

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.

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.

A policy toolkit for authorship and dissemination policies may benefit NIH research consortia.

Authorship and dissemination policies vary across NIH research consortia. We aimed to describe elements of real-life policies in use by eligible U01 clinical research consortia. Principal investigators of eligible, active U01 clinical research projects identified in the NIH Research Portfolio Online Reporting Tools database shared relevant policies. The characteristics of key policy elements, determined a priori, were reviewed and quantified, when appropriate. Twenty one of 81 research projects met search criteria and provided policies. K elements (e.g., in quotations): "manuscript proposals reviewed and approved by committee" (90%); "guidelines for acknowledgements" (86%); "writing team formation" (71%); "process for final manuscript review and approval" (71%), "responsibilities for lead author" (67%), "guidelines for other types of publications" (67%); "draft manuscript review and approval" (62%); "recommendation for number of members per consortium site" (57%); and "requirement to identify individual contributions in the manuscript" (19%). Authorship/dissemination policies for large team science research projects are highly variable. Creation of an NIH policies repository and accompanying toolkit with model language and recommended key elements could improve comprehensiveness, ethical integrity, and efficiency in team science work while reducing burden and cost on newly funded consortia and directing time and resources to scientific endeavors.

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.

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.

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.

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.

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.

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.

Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study.

Purpose: To test a novel bladder health tutorial on use of the Knack for overcoming bladder control challenges. The Knack-tutorial is a self-administered vignette-based instructional program on preempting bladder challenges in daily life (urgency, stress-leakage, or urge-leakage) through anticipatory, well-timed pelvic floor muscle contraction at the moment of challenge. Materials and Methods: This is a randomized controlled trial pilot test of 108 women with stress or mixed urinary incontinence. The Knack-tutorial group saw a 15-minute slide show with 10 vignettes portraying use of the Knack in daily life. The slide show format used inserted narrated videos, dubbed and animation enhanced pictures and cartoons, and automatic slide advancement. A control group saw a similarly constructed slide show on incorporating good diet/exercise habits. Outcomes were self-perceived improvement (yes/no, and as 0%-100%) 1 month after viewing the tutorial. Results: We enrolled 123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group. Eleven and one participant, respectively, did not return. Three did not fill out the self-perceived improvement report. Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group (p < 0.001). Self-perceived improvement was 21%-22% higher (Model I Est: 21.01, SE: 4.25, p < 0.001) in the Knack-tutorial group. Conclusions: An electronic tutorial viewed independent of a health care provider with vignettes showing Knack application to manage the everyday bladder challenges women face shows benefit of a magnitude that warrants more widespread use and rigorous testing. A professional remake of the intervention is now available (www.myconfidentbladder.com).

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.

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

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

Panzi score as a parsimonious indicator of urogenital fistula severity derived from Goh and Waaldijk classifications.

OBJECTIVE: To derive a comprehensive system that allows a single score to define relative fistula severity. METHODS: The present observational study included women with urogenital fistula treated at the Panzi Hospital, Democratic Republic of Congo, or its outreach clinics across the Democratic Republic of Congo between September 1, 2013, and December 31, 2014. Fistula severity was assessed by Goh and Waaldijk classifications and surgical success was ascertained. Logistic regression was used to select fistula characteristics predictive of surgical failure, and to preliminarily verify the newly derived Panzi score. RESULTS: Overall, 837 women were included in the analysis. Goh or Waaldijk fistula descriptors associated with a higher probability of poor surgical outcomes in the unadjusted bivariate analysis were circumferential defect (P=0.007), proximity to the external urethral orifice (P=0.001), and size (P=0.001). These fistula characteristics were used to construct the Panzi score, which varied from 3 (most severe) to 0 (minor fistula). For each increase above 0, the odds of surgical failure increase by a factor of 1.65 (P<0.001). CONCLUSION: The Panzi score of urogenital fistula provided a data-driven, simple, comprehensive, and parsimonious score. It could be used to report group data, to provide continuous level data for use in higher order statistics, and to resolve issues such as the cut-off point for referring women to hospital in accordance with fistula complexity.

Costs and Sustainability of a Behavioral Intervention for Urinary Incontinence Prevention.

INTRODUCTION: Many women choose behavioral interventions as first line treatment for urinary incontinence. We developed a 20-minute abbreviated video, which proved to be similar to a 2-hour in-person class in a randomized trial. This study examines economic end points for the 20-minute video relative to the 2-hour class. METHODS: We randomized 332 participants to the 2-hour class and 315 to the 20-minute video. We estimated the cost for the 2-hour class, the 20-minute video and followup health care utilization. Participants were followed for 3, 12 and 24 months, and asked about health care utilization, quality of life and lost productivity. To measure perceived value, we queried each participant regarding willingness to pay. Regression analysis was used for statistical comparisons. RESULTS: The estimated per participant cost for a 2-hour class was $38, which was more than the marginal cost of the video ($0). We found no significant differences between the treatment groups at each followup for quality of life, lost productivity or health care utilization. Women were willing to pay $26, $21 and $30 for a copy of the DVD, video on the Web and in-person class, respectively, all of which were less than the average cost of the in-person class ($38). CONCLUSIONS: Poor adherence remains a challenge for many behavioral interventions designed to prevent urinary incontinence. The 20-minute video is less expensive than the 2-hour class and is equally effective. Distributing the video on the Internet will improve access and will be easier to sustain than in-person classes.

Body after baby: a pilot survey of genital body image and sexual esteem following vaginal birth.

OBJECTIVE: The aim of this study was to determine acceptability of the Vaginal Changes Sexual and Body Esteem (VSBE) scale for women post childbirth and explore the association between childbirth events and sexual/body esteem. DESIGN: This is a cross-sectional study within the Evaluating Maternal Recovery from Labor and Delivery study. SETTING: This study was conducted in a community setting. POPULATION: The study was conducted in women post first vaginal birth with birth events that posed risk factors for levator ani muscle tears. METHODS: Survey, magnetic resonance images of levator ani, and physical examination were the data collected 8 months postpartum. Birth variables were collected by hospital chart review. Descriptive analysis of VSBE response rates and distribution of responses was conducted. An exploratory analysis of the potential association of demographic, birth, clinical, and magnetic resonance image characteristics with VSBE scores was conducted. MAIN OUTCOME MEASURES: The outcome measure used in this study is VSBE scale. RESULTS: The majority of participants (97%) completed the scale, with responses to most questions skewed toward positive sexual/body esteem, with the exception of sexual enjoyment, where 38% indicated some interference due to genital changes. The scale showed high internal consistency (alpha =0.93). In the exploratory analysis of potential characteristics associated with VSBE, women with episiotomies had lower sexual/body esteem compared to those who did not (median VSBE scores 35 vs 42.5, P=0.01). Anal sphincter tear was not associated with sexual/body esteem (P=0.78). Additional study is indicated to further explore observed trends toward the association of severe levator ani tear, maternal age at childbirth, and forceps with VSBE scores. CONCLUSION: The VSBE is suitable for use to assess sexual/body esteem in women post childbirth. Most women in this sample did not indicate negative genital body image/sexual esteem. However, some indicated that the changes post birth negatively affected their sexual/body esteem, particularly those who had episiotomies.

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.

It is not just menopause: symptom clustering in the Study of Women's Health Across the Nation.

BACKGROUND: Patterns of symptom clustering in midlife women may suggest common underlying mechanisms or may identify women at risk of adverse health outcomes or, conversely, likely to experience healthy aging. This paper assesses symptom clustering in the Study of Women's Health Across the Nation (SWAN) longitudinally by stage of reproductive aging and estimates the probability of women experiencing specific symptom clusters. We also evaluate factors that influence the likelihood of specific symptom clusters and assess whether symptom clustering is associated with women's self-reported health status. METHODS: This analysis includes 3289 participants in the multiethnic SWAN cohort who provided information on 58 symptoms reflecting a broad range of physical, psychological and menopausal symptoms at baseline and 7 follow-up visits over 16 years. We conducted latent transition analyses to assess symptom clustering and to model symptomatology across the menopausal transition (pre, early peri-, late peri- and post-menopausal). Joint multinomial logistic regression models were used to identify demographic characteristics associated with premenopausal latent class membership. A partial proportional odds regression model was used to assess the association between latent class membership and self-reported health status. RESULTS: We identified six latent classes that ranged from highly symptomatic (LC1) across most measured symptoms, to moderately symptomatic across most measured symptoms (LC2), to moderately symptomatic for a subset of symptoms (vasomotor symptoms, pain, fatigue, sleep disturbances and physical health symptoms) (LC3 and LC5) with one class (LC3) including interference in life activities because of physical health symptoms, to numerous milder symptoms, dominated by fatigue and psychological symptoms (LC4), to relatively asymptomatic (LC6). In pre-menopause, 10% of women were classified in LC1, 16% in LC2, 14% in LC3 and LC4, 26% in LC5, and 20% in LC6. Intensity of vasomotor and urogenital symptoms as well as sexual desire) differed minimally by latent class. Classification into the two most symptomatic classes was strongly associated with financial strain, White race/ethnicity, obesity and smoking status. Over time, women were most likely to remain within the same latent class as they transitioned through menopause stages (range 39-76%), although some women worsened or improved. The probability of moving between classes did not differ substantially by menopausal stage. Women in the highly symptomatic classes more frequently rated their health as fair to poor compared to women in the least symptomatic class. CONCLUSION: Clear patterns of symptom clustering were present early in midlife, tended to be stable over time, and were strongly associated with self-perceived health. Notably, vasomotor symptoms tended to cluster with sleep disturbances and fatigue, were present in each of the moderate to highly symptomatic classes, but were not a defining characteristic of the symptom clusters. Clustering of midlife women by symptoms may suggest common underlying mechanisms amenable to interventions. Given that one-quarter of midlife women were highly or moderately symptomatic across all domains in the pre-menopause, addressing symptom burden in early midlife is likely critical to ameliorating risk in the most vulnerable populations.

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.

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.