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OBJECTIVE: Financial strain and unmet social needs are associated with greater risk for lower urinary tract symptoms. Little research has examined financial strain and unmet social needs in relation to the more holistic concept of bladder health. This study utilizes baseline data from RISE FOR HEALTH: A U.S. Study of Bladder Health to examine whether financial strain, unmet social needs, and meeting specific federal poverty level threshold levels are associated with lower urinary tract symptoms and poorer perceived bladder health, well-being, and function. STUDY DESIGN: Participants were 18 years or older, born female or currently identified as a woman, and from the civilian, noninstitutionalized population residing in 50 counties in the United States that included or surrounded nine recruitment centers. Data were collected through mailed or internet-based surveys. To address research questions, the 10-item Lower Urinary Tract Dysfunction Research Network Symptom Index and selected Prevention of Lower Urinary Tract Symptoms Research Consortium bladder health scores were separately regressed on each financial strain, unmet social need, and federal poverty level variable, using linear regression adjusting for covariates (age, race/ethnicity, education, and vaginal parity) and robust variance estimation for confidence intervals. Participants with no missing data for a given analysis were included (range of n=2,564 to 3,170). In separate sensitivity analyses, body mass index, hypertension, and diabetes were added as covariates and missing data were imputed. RESULTS: The mean age of participants was 51.5 years (standard deviation=18.4). Not having enough money to make ends meet, housing insecurity, food insecurity, unreliable transportation, and percent federal poverty levels of 300% or less were consistently associated with more reported lower urinary tract symptoms and poorer perceived bladder health. For example, compared to food secure participants, women who worried that their food would run out at the end of the month had a Lower Urinary Tract Dysfunction Research Network - Symptom Index score that was 3.4 points higher (95% CI: 2.5, 4.3), on average. They also had lower mean scores across different bladder health measures, each assessed using a 100-point scale: global bladder health (-8.2, 95% CI: -10.8,-5.7), frequency (-10.2, 95% CI: -13.8,-6.7), sensation (-11.6, 95% CI: -15.1,-8.2), continence (-13.3, 95% CI: -16.7,-9.9), and emotional impact of bladder health status (-13.2, 95% CI: -16.5,-9.9). Across analyses, associations largely remained significant after additional adjustment for body mass index, hypertension, and diabetes. The pattern of results when imputing missing data was similar to that observed with complete case analysis; all significant associations remained significant with imputation. CONCLUSION: Financial strain and unmet social needs are associated with worse LUTS and poorer bladder health. Longitudinal research is needed to examine whether financial strain and unmet social needs influence the development, maintenance, and worsening of lower urinary tract symptoms; different mechanisms by which financial strain and unmet social needs may impact symptoms; and the degree to which symptoms contribute to financial strain. If supported by etiologic research, prevention research can be implemented to determine whether the amelioration of financial strain and social needs, including enhanced access to preventative care, may promote bladder health across the life course.
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INTRODUCTION AND HYPOTHESIS: Women with vulvovaginal or genital pain more commonly experience interstitial cystitis/bladder pain syndrome (IC/BPS) and urinary tract infections. However, the relationship between genital pain and bladder health is lacking. METHODS: Women in the Prevention of Lower Urinary Tract Symptoms Consortium's RISE FOR HEALTH population-based study answered questions about bladder health globally, and across nine bladder health domains of holding, efficacy, social-occupation, physical activity, intimacy, travel, emotion, perception, and freedom. Bladder function was assessed across six indices including urinary frequency, sensation, continence, comfort, emptying, and dysbiosis (e.g., urinary tract infections). Participants were grouped by no pain beyond transitory events (i.e., minor headaches, toothaches, or sprains), nongenital-related pain only, and any genital pain using a validated pain diagram. Mean adjusted scores and indices were compared using general linear modelling. RESULTS: Of 1,973 eligible women, 250 (12.7%) reported genital pain, 609 (30.9%) reported nongenital pain only, and 1,114 (56.5%) reported no pain. Women with any genital pain had lower (worse) adjusted mean scores across all bladder health scales (BHS; BHS global adjusted mean 47.5; 95% CI 40.8-54.1), compared with those with nongenital pain only (53.7; 95% CI 47.6-59.8), and no pain (59.3; 95% CI 53.3-65.4). Similarly, adjusted mean total Bladder Functional Index scores were lower for those with genital pain (63.1; 95% CI 58.4-67.9) compared with nongenital pain (72.1; 95% CI 67.7-76.5) and no pain (77.4; 95% CI 73.0-81.8). CONCLUSIONS: Heightened awareness of the relationship between genital pain and bladder health should prompt clinicians caring for women with genital pain to assess bladder health and function.
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AIMS: To describe women's experiences with a range of bladder self-care practices. DESIGN: We conducted a secondary, directed content analysis of qualitative data from the Study of Habits, Attitudes, Realities and Experiences, a multisite focus group study designed to explore adolescent and adult women's experiences, perceptions, beliefs, knowledge and behaviours related to bladder health. This study was conducted by the National Institute of Diabetes and Digestive and Kidney Diseases' Prevention of Lower Urinary Tract Symptoms Research Consortium. Study methods were informed by the Consortium's conceptual framework, based on a social ecological model adapted from Glass and McAtee's Society-Behavior-Biology Nexus. METHODS: Participants were recruited at seven geographically diverse United States research centres between July 2017 and April 2018. Data for the current analysis were collected using a semi-structured discussion group with 36 focus groups involving 316 community-dwelling adult women aged 18-93 years. Coded text was re-examined according to eight self-care behavioural domains identified through literature review and expert opinion as potentially influencing bladder health. RESULTS: Participants described many self-care practices they had adopted to prevent bladder problems or manage existing symptoms and conditions. Eight themes were identified: 'Choosing fluids, foods and medications'; 'Dressing for bladder health'; 'Promoting bodily cleanliness'; 'Managing toileting environments'; 'Timing when to void'; 'Exercising pelvic floor muscles for bladder control'; 'Limiting physical activities that challenge the bladder' and 'Staying home and navigating when away'. Thirteen subthemes were derived from five of the eight themes. CONCLUSION: Women use a broad array of self-care practices related to their bladder health. Research is needed to examine the efficacy of self-care behaviours for preventing or managing bladder symptoms and conditions, and to discern potential risks. Results have important implications for development of bladder health promotion interventions and public health messaging around women's bladder health. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: This study provides a comprehensive framework for understanding women's bladder self-care practices, which can be used by clinicians and public health professionals in designing interventions to promote bladder health and function. IMPACT: Women with and without lower urinary tract symptoms use a broad range of self-care practices that may affect their bladder health, including some that may be harmful. Because of the high prevalence of bladder symptoms in women, this study may help patient assessment and counselling regarding self-care practices. REPORTING METHOD: This study was reported according to the Standards for Reporting Qualitative Research (SRQR). PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.
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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.
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Síntomas del Sistema Urinario Inferior , Humanos , Síntomas del Sistema Urinario Inferior/epidemiología , Femenino , Prevalencia , Estados Unidos/epidemiología , Persona de Mediana Edad , Anciano , Adulto , Estudios de CohortesRESUMEN
PURPOSE: This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). MATERIALS AND METHODS: A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. RESULTS: A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. CONCLUSIONS: PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.
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Dolor Crónico , Calidad de Vida , Humanos , Femenino , Masculino , Evaluación Ecológica Momentánea , Dolor Crónico/diagnóstico , Dolor Pélvico/diagnóstico , Dimensión del DolorRESUMEN
PURPOSE: Although maternal depression is associated with adverse outcomes in women and children, its relationship with lower urinary tract symptoms (LUTS) in offspring is less well-characterized. We examined the association between prenatal and postpartum maternal depression and LUTS in primary school-age daughters. DESIGN: Observational cohort study. SUBJECTS AND SETTING: The sample comprised 7148 mother-daughter dyads from the Avon Longitudinal Study of Parents and Children. METHOD: Mothers completed questionnaires about depressive symptoms at 18 and 32 weeks' gestation and 21 months postpartum and their children's LUTS (urinary urgency, nocturia, and daytime and nighttime wetting) at 6, 7, and 9 years of age. Multivariable logistic regression models were used to estimate the association between maternal depression and LUTS in daughters. RESULTS: Compared to daughters of mothers without depression, those born to mothers with prenatal and postpartum depression had higher odds of LUTS, including urinary urgency (adjusted odds ratio [aOR] range = 1.99-2.50) and nocturia (aOR range = 1.67-1.97) at 6, 7, and 9 years of age. Additionally, daughters born to mothers with prenatal and postpartum depression had higher odds of daytime wetting (aOR range = 1.81-1.99) and nighttime wetting (aOR range = 1.63-1.95) at 6 and 7 years of age. Less consistent associations were observed for depression limited to the prenatal or postpartum periods only. CONCLUSIONS: Exposure to maternal depression in the prenatal and postpartum periods was associated with an increased likelihood of LUTS in daughters. This association may be an important opportunity for childhood LUTS prevention. Prevention strategies should reflect an understanding of potential biological and environmental mechanisms through which maternal depression may influence childhood LUTS.
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Depresión Posparto , Síntomas del Sistema Urinario Inferior , Nocturia , Embarazo , Niño , Femenino , Humanos , Estudios de Cohortes , Depresión Posparto/complicaciones , Depresión Posparto/epidemiología , Estudios Longitudinales , Depresión/complicaciones , Depresión/epidemiología , Núcleo Familiar , Nocturia/complicaciones , Nocturia/epidemiología , Síntomas del Sistema Urinario Inferior/complicaciones , Síntomas del Sistema Urinario Inferior/epidemiología , Instituciones AcadémicasRESUMEN
INTRODUCTION AND HYPOTHESIS: Lower urinary tract symptoms (LUTS) are common among adolescent girls. Physical activity (PA) has been implicated as both a risk (high-impact PA) and protective factor (low-impact, moderate to vigorous intensity PA) for LUTS in adult women, but its role in adolescent girls is unclear. This study investigated the prospective association between physical activity and LUTS risk in adolescent girls. METHODS: The sample comprised 3,484 female participants in the Avon Longitudinal Study of Parents and Children. Multivariate logistic regression models were used to examine daily minutes of moderate to vigorous PA (MVPA) at ages 11 and 15 years in relation to LUTS at ages 14 and 19 respectively. MVPA was assessed by 7-day accelerometer data. LUTS were assessed by questionnaire. MVPA were analyzed as continuous (minutes/day) and categorical variables (<10th percentile, 10-89th percentile, ≥90th percentile). RESULTS: Prevalence of LUTS ranged from 2.0% for bedwetting to 9.5% for nocturia at age 14 and from 2.0% for straining to urinate to 35.5% for interrupted urine flow at age 19. Physical activity was not associated with LUTS at either time-point. CONCLUSIONS: Given the prevalence of LUTS in female adolescent populations, although this study did not find an association with accelerometer-measured MVPA, other aspects of PA that may serve as risk or protective factors deserve investigation.
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Síntomas del Sistema Urinario Inferior , Nocturia , Niño , Adulto , Humanos , Femenino , Adolescente , Adulto Joven , Estudios Longitudinales , Síntomas del Sistema Urinario Inferior/epidemiología , Síntomas del Sistema Urinario Inferior/etiología , Ejercicio Físico , PadresRESUMEN
Anticholinergics have been used in the treatment of overactive bladder (OAB), but their use is limited by poor tolerability and anticholinergic-related side effects. Increasingly, providers are discontinuing anticholinergic prescribing because of growing evidence of the association of anticholinergic use with increased risk of cognitive decline and other adverse effects. Newer medications for OAB, the ß3-adrenergic receptor agonists mirabegron and vibegron, do not have anticholinergic properties and are typically well tolerated; however, many insurance plans have limited patient access to these newer OAB medications by requiring step therapy, meaning less expensive anticholinergic medications must be trialed and/or failed before a ß3-agonist will be covered and dispensed. Thus, many patients are unable to easily access these medications. Step therapy and other drug utilization strategies (e.g., prior authorization) are often used to manage the growing costs of pharmaceuticals, but these policies do not always follow treatment guidelines and may harm patients as a result of treatment delays, discontinuations, or related increases in adverse events. Medical professionals have called for reform of drug utilization strategies through partnerships that include clinicians and policymakers. This narrative review discusses prescribing patterns for OAB treatment and the effect of switching between drugs, as well as the costs of step therapy and prior authorization on patients and prescribers.
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Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Antagonistas Colinérgicos/efectos adversos , Agonistas de Receptores Adrenérgicos beta 3/efectos adversosRESUMEN
Objective: The purpose of this analysis was to explore adolescent and adult women's preferences for the content and delivery of public health messaging around bladder health. Materials and Methods: This was a directed content analysis of focus group data from the Study of Habits, Attitudes, Realities, and Experiences, which explored adolescent and adult women's experiences, perceptions, beliefs, knowledge, and behaviors related to bladder health and function across the life course. This article reports an analysis of the "Public Health Messaging" code, which includes participants' views on what information is needed about bladder health, attributes of messaging, and preferred locations and delivery methods. Results: Forty-four focus groups were conducted with 360 participants (ages 11-93 years) organized into six age groups. Across age groups, participants wanted messaging on maintaining bladder health and preventing bladder problems. They offered suggestions for a wide variety of methods to deliver bladder health information. Ideas for delivery methods fell into three broad categories: (1) traditional in-person modes of delivery, which included individual communication with providers in clinical settings and group-based methods in schools and other community settings where adolescent and adult women naturally gather; (2) internet-based website and social media delivery methods; and (3) static (noninteractive) modes of delivery such as pamphlets. Participants recommended the development of multiple delivery methods to be tailored for specific audiences. Conclusions: These findings can inform development of broad ranging public health messaging tailored to audiences of all ages with a goal of engaging adolescent and adult women across the bladder health risk spectrum.
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Salud Pública , Vejiga Urinaria , Adulto , Femenino , Humanos , Adolescente , Grupos Focales , Comunicación , Instituciones Académicas , Investigación CualitativaRESUMEN
What is this summary about? This is a plain language summary of an article published in the journal Advances in Therapy. In 2020, the US Food and Drug Administration (also called the FDA) approved a medicine called vibegron to treat overactive bladder, also called OAB. The key results used to approve vibegron were from the EMPOWUR study. In the EMPOWUR study, participants who took vibegron had fewer urination episodes, urgency episodes, and bladder leaks each day than those who took a pill containing no medicine, called a placebo. At the end of the study, participants also rated how much their overactive bladder symptoms changed overall during EMPOWUR by responding to a survey. Many participants rated their overactive bladder symptoms as improved overall. This study asked if improvements in the number of urination episodes, urgency episodes, and bladder leaks caused by urgency were associated with feeling better overall. This study also looked at how many participants in the EMPOWUR study had improvements in the number of urination episodes, urgency episodes, and bladder leaks that were big enough to matter. A separate group of people with overactive bladder were asked about the magnitude of improvements that would be important to them. This group had not participated in the EMPOWUR study. What were the results? EMPOWUR participants who reported that taking medicine resulted in their overactive bladder symptoms getting better overall also generally reported fewer daily urinations, urgency episodes, and bladder leaks after treatment. Many had changes in their symptoms that were meaningful. Meaningful was defined for each symptom as: at least 15% fewer urinations, 50% fewer urgency episodes, and 75% fewer bladder leaks. Participants who received vibegron had meaningful reductions in the daily number of episodes of urination, urgency, and bladder leaks more often than those who received the placebo (pill with no active medicine). People with overactive bladder who did not participate in the study were interviewed and said that improvements to those symptoms, similar to those seen in the EMPOWUR study, would be important to them. What do the results mean? This study suggests that the results we measured in the EMPOWUR study may also reflect changes in overactive bladder symptoms that are big enough to be important to people with overactive bladder. Many participants who took vibegron in the EMPOWUR study felt that it helped to improve their individual overactive bladder symptoms. This may also help improve quality of life of participants. Clinical Trial Registration: NCT03492281 (ClinicalTrials.gov).
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Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Calidad de Vida , Resultado del Tratamiento , MicciónRESUMEN
Background: Lower urinary tract symptoms (LUTS) are prevalent across women's life course. Evidence shows toileting behaviors (TBs) and urinary urge cues are related to LUTS. It is unknown when women start using these behaviors and responding to urinary cues. Methods: An online survey was administered to 338 women, 65 years of age and older, to assess the age of onset for 20 TBs from the Toileting Behaviors-Women's Elimination Behavior (TB-WEB) questionnaire, 10 urinary urge cues from the Urinary Cues Questionnaire, and urinary urgency and leakage items from the International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) Short Form. Descriptive statistics were reported for each TB and urinary cue. A timeline was generated with the average earliest age of onsets for each type of TB, urinary cues, and urinary urgency and leakage symptoms. Results: Place preference, delayed voiding, and hovering over toilets away from home were reported to have the earliest ages of onset. Urinary urge cues, premature voiding, and straining to void tended to start after 45 years of age, as did the symptoms of urinary urgency and leakage. The timeline indicated that the earliest place preference and position preference TBs started before 20 years of age. Conclusion: Some TBs begin early in life and persist into old age, while other TBs and urinary cues begin later. Bladder health promotion may depend on intervening at specific times in the life course to alter TBs and responses, and potentially making environmental changes.
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OBJECTIVE: The objective of this study was to describe adherence to behavioral and pelvic floor muscle training in women undergoing vaginal reconstructive surgery for organ prolapse and to examine whether adherence was associated with 24-month outcomes. METHODS: Participants were women ≥18 years of age, with vaginal bulge and stress urinary incontinence symptoms, planning to undergo vaginal reconstructive surgery for stages 2 to 4 vaginal or uterine prolapse. They were randomized to either sacrospinous ligament fixation or uterosacral ligament suspension and to perioperative behavioral and pelvic floor muscle training or usual care. Measurements included anatomic failure, pelvic floor muscle strength, participant-reported symptoms, and perceived improvement. Analyses compared women with lower versus higher adherence. RESULTS: Forty-eight percent of women performed pelvic floor muscle exercises (PFMEs) daily at the 4- to 6-week visit. Only 33% performed the prescribed number of muscle contractions. At 8 weeks, 37% performed PFMEs daily, and 28% performed the prescribed number of contractions. No significant relationships were found between adherence and 24-month outcomes. CONCLUSION: Adherence to a behavioral intervention was low following vaginal reconstructive surgery for pelvic organ prolapse. The degree of adherence to perioperative training did not appear to influence 24-month outcomes in women undergoing vaginal prolapse surgery. IMPACT: This study contributes to the understanding of participant adherence to PFMEs and the impact that participant adherence has on outcomes at 2, 4 to 6, 8, and 12 weeks and 24 months postoperatively. It is important to educate women to follow up with their therapist or physician to report new or unresolved pelvic symptoms.
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Prolapso de Órgano Pélvico , Procedimientos de Cirugía Plástica , Prolapso Uterino , Femenino , Humanos , Terapia Conductista , Diafragma Pélvico , Prolapso de Órgano Pélvico/cirugía , Resultado del Tratamiento , Prolapso Uterino/cirugía , Procedimientos de Cirugía Plástica/métodosRESUMEN
Background: While psychological difficulties, such as depression, among prostate cancer patients are known, their longitudinal burden remains understudied. We assessed the burden of depression across low-, intermediate- and high-risk prostate cancer groups, and the association between regret and long-term depression. Methods: Secondary analysis of data from a multi-centered randomized controlled study among localized prostate cancer patients was carried out. Assessments were performed at baseline, and at 3-, 6-, 12- and 24-month follow-up. Depression was assessed using the Center for Epidemiologic Studies Depression (CES-D) scale. A CES-D score ≥ 16 indicates high depression. Regret was measured using the regret scale of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The proportion of patients with high depression was compared over time, for each risk category. Logistic regression was used to assess the association between regret, and long-term depression after adjusting for age, race, insurance, smoking status, marital status, income, education, employment, treatment, number of people in the household and study site. Results: The study had 743 localized prostate cancer patients. Median depression scores at 6, 12 and 24 months were significantly larger than the baseline median score, overall and for the three prostate cancer risk groups. The proportion of participants with high depression increased over time for all risk groups. Higher regret at 24-month follow-up was significantly associated with high depression at 24-month follow-up, after adjusting for covariates. Conclusions: A substantial proportion of localized prostate cancer patients continued to experience long-term depression. Patient-centered survivorship care strategies can help reduce depression and regret, and improve outcomes in prostate cancer care.
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BACKGROUND: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective ß3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. METHODS: This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. DISCUSSION: OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.
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Vejiga Urinaria Hiperactiva , Adulto , Humanos , Adolescente , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Calidad de Vida , Estudios Prospectivos , Resultado del Tratamiento , Acetanilidas/uso terapéutico , Método Doble Ciego , Antagonistas Colinérgicos/uso terapéutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapéutico , Antagonistas Muscarínicos/uso terapéuticoRESUMEN
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).
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Síntomas del Sistema Urinario Inferior , Vejiga Urinaria Hiperactiva , Incontinencia Urinaria , Embarazo , Humanos , Femenino , Vejiga Urinaria , Conocimientos, Actitudes y Práctica en Salud , Estudios Longitudinales , Incontinencia Urinaria/diagnóstico , Incontinencia Urinaria/prevención & control , Vejiga Urinaria Hiperactiva/diagnóstico , Vejiga Urinaria Hiperactiva/terapia , Síntomas del Sistema Urinario Inferior/diagnóstico , Síntomas del Sistema Urinario Inferior/prevención & controlRESUMEN
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.
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Nocturia , Vejiga Urinaria , Humanos , Femenino , Adolescente , Adulto , Vida Independiente , Estudios Transversales , Registros Médicos , DolorRESUMEN
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.
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Instrucción por Computador , Prolapso de Órgano Pélvico , Enfermedades de la Vejiga Urinaria , Femenino , Humanos , Contracción Muscular/fisiología , Músculos , Terapia por EjercicioRESUMEN
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.
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Calidad de Vida , Vejiga Urinaria , Adulto , Humanos , Femenino , Reproducibilidad de los Resultados , Estudios Transversales , Psicometría/métodos , Encuestas y CuestionariosRESUMEN
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.
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Síntomas del Sistema Urinario Inferior , Diafragma Pélvico , Adulto , Humanos , Femenino , Estudios Prospectivos , Vejiga Urinaria , DolorRESUMEN
OBJECTIVES: To describe the methods for the in-person musculoskeletal (MSK) assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors associated with bladder health (BH) conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS: A subset of RISE participants who express interest in the in-person assessment are screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete a standardized MSK assessment to evaluate core stability (four component core stability test, lumbar spine pain (seated slump test), pelvic girdle pain, (sacroiliac joint, anterior superior iliac spine, pubic symphysis tenderness, and pelvic girdle pain provocation test), hip pain (flexion, abduction, internal rotation and flexion, adduction and external rotation) and pelvic girdle function (active straight leg raise). Participants are also asked to complete the Short Physical Performance Battery to measure balance, gait speed, lower extremity strength, and functional capacity. RESULTS: Detailed online and in-person MSK training sessions led by physical therapy were used to certify research staff at each clinical center before the start of RISE in-person assessments. All evaluators exceeded the pre-specified pass rates. CONCLUSIONS: The RISE in-person MSK assessment will provide further insight into the role of general body MSK health and dysfunction and the spectrum of BH.