Nocturia (i.e., waking to void during the primary sleep period) of two or more times per night affects nearly one-third of older adults and can have a severe impact on sleep, contributing to insomnia symptoms. Current treatment approaches for nocturia often overlook non-lower urinary tract factors that may contribute to nighttime awakenings. Nocturia management, for example, may benefit from more effective integration of cognitive behavioral therapy for insomnia (CBT-I) principles that address other factors underlying insomnia symptoms, and early evidence suggests it also reduces nocturia and the bother it causes. Because nocturia treatment crosses specialties, coordinated delivery of urological and sleep therapies is a treatment barrier. The overall purpose of this trial is to determine whether a promising coordinated, integrated behavioral, non-pharmacological, non-surgical treatment that simultaneously addresses both the urological and insomnia factors contributing to nocturia is efficacious for improving nocturia, sleep, and daytime function. This multicenter parallel-group randomized, efficacy trial compares a 5-week integrated behavioral treatment program delivered by a single interventionist (psychologist, nurse practitioner, or physician assistant) to a health education control program in adults aged 60 years or older (proposed n = 192) recruited from sites in Atlanta and Los Angeles, who report typically getting up to urinate two or more times per night (International Consultation on Incontinence Questionnaire-Overactive bladder [ICIQ-OAB] nocturia item) and insomnia symptoms (Insomnia Severity Index > 7). The integrated program includes components of CBT-I and pelvic floor muscle exercise-based behavioral therapy for nocturia. The primary outcome is ICIQ-OAB-measured nocturia frequency 4 months after randomization. Secondary outcomes are sleep diary-measured wake after sleep onset (mean minutes) and Insomnia Severity Index total score. The interdisciplinary trial team has developed a program aimed at improving nocturia symptoms and overall sleep of older adults in an efficient and safe manner. The integrated behavioral program has the potential to address nocturia, which is a challenging symptom because it has many etiologies that cross multiple specialties. Findings will provide rigorous evidence of the efficacy of the integrated behavioral treatment program to reduce nocturia frequency as well as sleep disturbance in older adults. Clinicaltrials.gov NCT06110091, registered 10/25/2023.
BACKGROUND:Psychological and trauma-related factors (ie, stress, anxiety, post-traumatic stress disorder, and military sexual trauma) may induce physiological responses that contribute to urinary incontinence. Women veterans are disproportionately affected by psychological and trauma-related factors, which may influence urinary incontinence severity and response to behavioral urinary incontinence treatment. OBJECTIVE:We aimed to examine associations between psychological and trauma-related factors and both urinary incontinence severity and response to behavioral urinary incontinence treatment among women veterans. STUDY DESIGN:We conducted a secondary analysis of data from a randomized controlled trial that evaluated the effectiveness of 2 remote urinary incontinence behavioral treatment modalities in 3 southeastern Veterans Healthcare Administration systems from April 2020 to September 2023. Urinary incontinence severity was measured with International Consultation on Incontinence-Urinary Incontinence Short Form scores to reflect urinary incontinence frequency and amount leaked. Treatment response was defined as a 2.52-point reduction in International Consultation on Incontinence-Urinary Incontinence Short Form scores and modeled as a binary outcome. Stress was assessed with the Perceived Stress Scale-10. Military sexual trauma was determined based on 2 validated Veterans Health Administration screening items. Post-traumatic stress disorder and anxiety were assessed with self-reported items indicating whether participants were ever diagnosed with these conditions. We performed bivariate analyses to examine differences in sample characteristics by treatment response status. We used linear regression models to examine associations between each psychological and trauma-related factor and urinary incontinence severity at baseline and reported β coefficients. We used logistic regression models to estimate the odds of treatment response by each psychological and trauma-related factor. RESULTS:Among 200 women veterans (mean age=54 years, standard deviation=11), the most commonly reported psychological and trauma-related factors were anxiety (138/200, 69%), military sexual trauma (120/200, 60%), and post-traumatic stress disorder (101/200, 51%), and their mean perceived stress score was 17.9 (standard deviation=8.6) indicating moderate stress. Higher levels of perceived stress (β=0.18, 95% confidence interval [0.08, 0.27], P<.001), diagnosed anxiety (β=3.35, 95% confidence interval [1.73, 4.97], P<.001), post-traumatic stress disorder (β=1.96, 95% confidence interval [0.40, 3.51], P=.02), and reported military sexual trauma (β=1.80, 95% confidence interval [0.18, 3.41], P=.03) were significantly associated with greater urinary incontinence severity after adjusting for age, race, ethnicity, education level, body mass index, vaginal parity, menopausal status, medication for urinary incontinence, hysterectomy status, and randomization group. In total, 55% (109/200) of women veterans were classified as treatment responders. Higher levels of perceived stress were associated with lower odds of response to behavioral urinary incontinence treatment in the adjusted model (adjusted odds ratio=0.98, 95% confidence interval [0.97, 0.99], P=.01). CONCLUSION:Findings highlight the importance of understanding what psychological and trauma-related factors are associated with urinary incontinence among women and underscore the need for trauma-informed, interdisciplinary approaches to urinary incontinence care to improve health outcomes.
BACKGROUND:To understand cross-sectional associations between lower urinary tract symptoms (LUTS) and specific cognitive domains, we examined cognitive performance in older adults with and without LUTS. METHODS:The study comprised a subset of Black and White participants, aged 45 and older, enrolled in the REasons for Geographic and Racial Differences in Stroke (REGARDS) national, longitudinal cohort study 2003-2007. Computer-assisted telephone interviews were conducted for follow-up every 6 months including an established cognitive battery: Six-Item Screener (SIS) for cognitive impairment, animal naming, letter F naming, word list learning, and delayed recall for verbal fluency/executive function and verbal memory. Validated LUTS questionnaires were administered beginning in 2020 at 6-month intervals. Separate linear and logistic regression models for men and women estimated associations between LUTS and cognitive battery scores, adjusting for covariates. RESULTS:From the 10,464 participants (6026 women, 4438 men), 70% of women reported LUTS (mean age 69 ± 8 years) versus 62% of men (mean age 63 ± 7 years). More Black men reported LUTS compared to White men, 69% versus 59% (p < 0.001), respectively, without differences among Black and White women. Men and women with LUTS had decreased odds of being cognitively intact based on the SIS, OR 0.65, 95% CI 0.50, 0.85 and OR 0.64, 95% CI 0.46, 0.78, respectively. Men with LUTS had lower scores for Animal Naming (β -0.42, 95% CI -0.75, -0.08) and Delayed Recall (β -0.18, 95% CI -0.30, -0.05). Women with LUTS had lower test scores for Letter F Naming (β -0.29, 95% CI -0.55, -0.04), Word List Learning (β -0.40, 95% CI -0.68, -0.11) and Delayed Recall (β -0.13, 95% CI -0.25, -0.02). CONCLUSIONS:Older adults with LUTS have subtle differences in cognitive function, especially in new learning, verbal memory, and verbal fluency/executive function that should be considered in treatment decisions.
Importance and Objective Behavioral treatments are recognized as evidence-based approaches for treatment of urinary incontinence (UI) in women. However, many women do not have in-person access to qualified providers, which has led to the emergence of remote methods of delivery for behavioral treatment. The purpose of this study was to identify salient features of participants’ experiences with two modalities for remote delivery of behavioral treatment for UI within a pragmatic randomized trial. Design, Setting, and Participants Individual qualitative interviews were conducted to explore the views and experiences of women Veterans who completed behavioral treatment delivered by a mobile health application (MyHealtheBladder, MHB) or video visit via VA Video Connect (VVC). The study was conducted at 3 Southeast VA healthcare systems (April 2020 - September 2023). Interventions MHB consisted of 56 self-administered daily sessions delivered remotely over 8 weeks. VVC consisted of a single session with a specialized UI provider. After the first 8 weeks, women identified as nonresponders (based on self-reported symptom improvement) were randomized to an additional VVC session or no session. Analysis A hybrid qualitative content analysis integrating deductive and inductive methods was conducted to identify the most frequently occurring and highly emphasized topics. Results Of the 188 women Veterans who completed the first 8-week treatment, 41 completed the interview. Participants focused on three topics: (1) encountering technical and logistical issues in access and use; (2) interacting with the program content; and (3) finding motivation, encouragement, and inspiration. Participants in both arms of the study spoke of the importance of the structure and process of content presentation, emphasizing mechanisms for reminders, review and feedback. They also valued the woman Veterans’ UI stories and provider verbal and nonverbal expressions of care and support as sources of motivation and encouragement. MHB participants reported far fewer challenges with accessing information compared to their VVC counterparts. Conclusion Future mobile health programs should incorporate mechanisms for smooth navigation of MHB and timely provider feedback, as well as strategies to ensure patients can access VVC and are prepared for participation in ways that optimize their engagement with the behavioral treatment program.
Overactive bladder (OAB) symptoms in Parkinson disease (PD) are burdensome, and the adverse effects of drug treatment can worsen PD-associated morbidity. Drug adverse effects are avoided with pelvic floor muscle exercise–based behavioral therapy. To assess the noninferiority of behavioral compared with solifenacin drug therapy for OAB symptoms in persons with PD. This 12-week randomized noninferiority trial of behavioral therapy compared with solifenacin was conducted between 2018 and 2023 within 4 US Veterans Affairs health care systems. Eligible participants were diagnosed with PD by a movement disorder neurologist and had an International Consultation on Incontinence Questionnaire OAB module (ICIQ-OAB) symptom score of 7 or higher (range, 0-16; higher score indicates worse symptoms) and Montreal Cognitive Assessment (MOCA) score of 18 or higher (range, 0-30). Participants were randomized 1:1 after stratification by sex, recruitment site, OAB severity, and PD motor symptom severity. Analyses were conducted from October 2023 to April 2024. Behavioral therapy was implemented by a nurse practitioner and included pelvic floor muscle training and urge suppression strategies. Solifenacin therapy started at 5 mg daily, with titration to 10 mg daily if needed. The primary outcome was the 12-week ICIQ-OAB score across groups within a 15% noninferiority margin. Adverse events were assessed every 2 weeks for 8 weeks and again at 12 weeks. A total of 77 persons with PD (65 [84%] male; mean [SD] age, 71.3 [8.9] years; mean [SD] years with PD, 6.6 [5.8]) were randomized to behavioral (n = 36) or drug therapy (n = 41). Seventy-three participants completed the study (4 dropped out in drug group). Baseline characteristics were balanced across groups, including MOCA score (mean [SD], drug, 23.9 [3.1]; behavioral, 24.8 [3.3]) and ICIQ-OAB score (mean [SD], drug, 9.1 [1.7]; behavioral, 8.5 [1.4]). At 12 weeks postrandomization, ICIQ-OAB scores across groups indicated clinically significant improvement and were within the a priori noninferiority margin of 15% (mean [SD] score, drug, 5.8 [2.4]; behavioral, 5.5 [2.0]; P = .02). Dry mouth and falls were reported more frequently in the drug compared with the behavioral group. Results of this randomized noninferiority trial suggest that behavioral therapy is noninferior to drug therapy in improving OAB symptoms in PD. These findings may inform clinical guidelines for urinary symptoms in PD to consider behavioral therapy as an initial treatment option. ClinicalTrials.gov Identifier: NCT03149809
Purpose: Qualitative studies exploring bladder health are rare compared to research focusing on lower urinary tract symptoms (LUTS). Our aim was to explore adolescent and adult women's perceptions about what constitutes a healthy bladder. Methods: We conducted a 7-site focus group study of bladder health with adolescent and adult women across six age categories (11-14 to 65+ years). Transcripts were analyzed using transdisciplinary, directed content analysis and an iterative interpretive consensus building approach to identify key constructs, focusing on "healthy bladder"and "unhealthy bladder"codes. Results: Forty-four focus groups with 360 participants were completed. Three thematic categories were identified: (1) concept of a healthy bladder (conceptual abstraction); (2) experience of a healthy bladder (subjective experience); and (3) lifestyle and life course considerations (bladder health in context). Participants struggled to define the unfamiliar concept of healthy bladder and relied on contextualized experiences and behaviors for characterizing bladder health. They described the concept of a healthy bladder as something that you did not need to think about but did require attention to healthy habits to maintain. Other features of a healthy bladder discussed include having bladder control despite urgency and environmental constraints on voiding, normal voiding frequency, and qualities of urine and urination. Participants struggled with lack of information about healthy bladder habits and noted absence of routine bladder health screening. Discussion: Findings identify need to promote public education and information sharing in health care visits about bladder health. Further they can inform bladder health promotion and clinical research on LUTS prevention.
Introduction: Toileting behaviors are recognized as potential contributors to lower urinary tract symptoms (LUTS) in women. This study examines the association between toileting behaviors and LUTS among community-dwelling women and whether age modifies these associations. Methods: Cross-sectional analyses were conducted using baseline data from a population-based cohort study, RISE FOR HEALTH (RISE). Women completed validated questionnaires assessing toileting behaviors (Toileting Behaviors-Women's Elimination Behaviors scale) and LUTS (10-item Lower Urinary Tract Dysfunction Research Network-Symptom Index [LURN SI-10]). Toileting behaviors included place preference for voiding, premature voiding, delayed voiding, straining to void, and toileting position. LUTS items included urine storage, emptying, and postmicturition symptoms. Associations were analyzed by proportional odds logistic regression. Analyses were stratified by seven age groupings. Results: Data from 2,327 women (mean age 51.1 years, standard deviation = 18.2) were analyzed. Delayed voiding was most strongly associated with the LURN SI-10 composite score (odds ratio [OR] 1.89; 95% confidence interval [CI]: 1.72, 2.09) and urgency incontinence (OR 1.87; 95% CI: 1.66, 2.10). Premature voiding showed the strongest association with urgency (OR 1.82; 95% CI: 1.68, 2.04). Straining was strongly associated with emptying symptoms, including delay before urine starts (OR 2.28; 95% CI: 2.05, 2.54) and slow stream (OR 2.28; 95% CI: 2.05, 2.53). Age modified associations between delayed voiding and LUTS, with strongest associations among 18- to 25 year-old women. Conclusions: Premature voiding, delayed voiding, and straining showed the strongest associations with LUTS in this cross-sectional analysis. Longitudinal studies are needed to clarify the directionality of these associations. Educating young women on healthy toileting habits may mitigate potential effects of unhealthy toileting behaviors on bladder health.
Importance:Initial treatment for urinary incontinence (UI) includes behavioral treatment. However, access to care may be limited. Objective:To compare the effectiveness of 2 remote modalities for UI behavioral treatments and to assess the effect of a booster video visit for treatment nonresponders. Design, Setting, and Participants:This sequential, multiple assignment randomized clinical trial was conducted in 3 southeastern US Department of Veterans Affairs health care systems from April 2020 through September 2023. Participants were nonpregnant women veterans with UI who had access to email. Interventions:Remote interventions included (1) a mobile health UI app (MyHealtheBladder) with daily sessions delivered for 8 weeks or (2) a single video visit through VA Video Connect delivered by trained UI health care professionals and (3) a randomized booster video visit for women without UI symptom improvement at 8 weeks. Main Outcomes and Measures:The primary outcome was change in UI symptoms at 12 weeks as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF; score range, 0-21, with higher scores indicating more severe UI) with a minimal clinically important difference of 2.52 defining response status at 8 weeks. The results of the sequential addition of a video booster visit for nonresponders in both randomization groups were also investigated. Primary analyses were assessed using intention-to-treat and per-protocol analyses. Results:Of 286 women veterans randomized (147 to UI app; 139 to video visit), 244 (85%) received an intervention. Their mean (SD) age was 53.2 (11.3) years (range, 23-83 years). At 12 weeks, ICIQ-UI SF scores for the UI app group decreased -3.6 (95% CI, -4.4 to -2.8) points compared with -2.3 (95% CI, -3.1 to -1.5) points for the video visit group (P = .02). In the UI app nonresponder group at 8 weeks (n = 29 [20%]) with the booster video visit (n = 12), ICIQ-UI SF scores changed -1.0 (95% CI, -2.4 to 0.4) points vs -1.2 (95% CI, -1.3 to 3.7) points for 10 UI app nonresponders who continued UI app treatment (P = .10). In the video visit nonresponder group (n = 61 [44%]) with the booster video visit (n = 23), ICIQ-UI SF scores changed -0.9 (95% CI, -2.1 to 0.3) points vs -0.3 (95% CI, -1.9 to 1.2) points in 30 video visit nonresponders who continued treatment (P = .58). The change in ICIQ-UI SF scores for the UI app reached the MCID threshold (2.52 points) in 4 weeks (-2.9 [95% CI, -3.8 to -2.0] points), whereas the video visit group did not reach this threshold until 24 weeks (-3.4 [95% CI,-4.2 to -2.5] points). Conclusions and Relevance:This randomized clinical trial comparing 2 remote delivery modalities of behavioral UI treatment with randomized booster visits among women veterans found that UI symptoms improved earlier for the UI app intervention compared with the video visit intervention, without reaching a meaningful clinical between-group difference at 12 weeks. The addition of a booster video visit did not further improve UI symptoms. Further research could extend these modalities to broaden access to behavioral UI treatment. Trial Registration:ClinicalTrials.gov Identifier: NCT04237753.
Background:Women commonly experience lower urinary tract symptoms (LUTS), such as frequent urination, urgent urination, and urinary incontinence. Health education for women rarely focuses on LUTS prevention and promotion of bladder health. The Theory of Reasoned Action and the Theory of Planned Behavior have been used to explain and change a variety of health behaviors. Missing from the literature is an explicit test of whether constructs of these theories are associated with LUTS and bladder health, and whether toileting habits explain this association.Objectives:To inform prevention strategies, this investigation tested whether the Theory of Reasoned Action and Theory of Planned Behavior constructs (attitudes toward, perceived norms of, and perceived control over specific toileting behaviors) are associated with women's toileting habits, and whether these habits mediate associations of theoretical constructs and women's LUTS and bladder health.Methods:The Prevention of Lower Urinary Tract Symptoms Research Consortium developed theoretical constructs to match four toileting behavior domains (delayed voiding, straining, crouching/hovering over toilets when away from home, and avoiding public toilets) assessed by the validated Toileting Behaviors: Women's Elimination Behaviors scale. Using a population-based survey, data were then collected from women at nine sites in the United States. Cross-sectional regression analyses tested whether toileting habits in a given domain mediated associations of corresponding theoretical constructs with reported LUTS, bladder health, and bladder function.Results:The overall analytic sample included 1,472 women with a mean age of 48 years. Associations of norms favoring delayed voiding and low perceived control over timing of voiding with more frequent LUTS and poorer bladder health and function were partially mediated by delayed voiding habits. Favorable attitudes toward and norms of straining (i.e., pushing down to urinate) and avoiding public toilets were associated with more frequent LUTS through corresponding toileting habits.Discussion:Longitudinal research is needed to confirm study findings. Future prevention intervention research may include nursing and public health messaging designed to shape attitudes toward and perceived norms of specific toileting behaviors, as well as policies to enhance control over healthy toileting practices in public spaces, including schools and workplaces.
You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction (Excluding OAB) (MP75)1 May 2024MP75-11 LOWER URINARY TRACT SYMPTOMS AND CORONARY HEART DISEASE RISK AMONG PARTICIPANTS OF THE REASONS FOR GEOGRAPHIC AND RACIAL DIFFERENCES IN STROKE (REGARDS) COHORT STUDY Alayne D. Markland, Kathryn L. Burgio, Belinda Williams, Richard Kennedy, Sara Elgayar, Yue Zhang, and Virginia J. Howard Alayne D. MarklandAlayne D. Markland , Kathryn L. BurgioKathryn L. Burgio , Belinda WilliamsBelinda Williams , Richard KennedyRichard Kennedy , Sara ElgayarSara Elgayar , Yue ZhangYue Zhang , and Virginia J. HowardVirginia J. Howard View All Author Informationhttps://doi.org/10.1097/01.JU.0001008676.21744.5f.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Known associations exist for coronary heart disease (CHD) and lower urinary tract symptoms (LUTS), with more cross-sectional evidence that LUTS are associated with CHD among men than women. However, less is known about the risk of having a CHD event among adults with LUTS. We examined the distribution of LUTS and the estimated risk of having a CHD event by sex among participants in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. METHODS: REGARDS is a national, longitudinal cohort study of 30,239 Black and White adults aged 45+ years, recruited in 2003-2007 with assessments for CHD risk factors, and repeated in 2013-2016. We analyzed data from a subsample of 6062 women and 4438 men who answered validated LUTS questionnaires (ICIQ-Female-LUTS and Male-LUTS; range 0-28) in 2019-2020. CHD risk was assessed using the Framingham CHD 10-year risk score, which includes measurement of age, sex, systolic blood pressure, total cholesterol, high density lipoprotein, diabetes, and smoking. We dichotomized LUTS as none/very mild (score 0-3) or mild/moderate/severe (score 4-28). After excluding participants with prevalent CHD, we analyzed 2,833 women and 1,604 men for the association of LUTS with 10-year CHD risk scores (beta coefficients and 95% confidence intervals). We performed separate multivariable linear regression models for women and men at risk for CHD adjusting for sociodemographic variables (age, race, education, and urban-rural setting) and body mass index (BMI). RESULTS: Overall, 70% of women reported LUTS (mean age 61.9±7.8 years, 41% Black, 59% White) and 62% of men reported LUTS (mean age 62.8±7.3 years, 29% Black, 71% White). After adjustment for sociodemographics and BMI, the risk of CHD in women with LUTS was beta 6.03, 95% CI -8.26, 20.31, p=0.40 and the risk of CHD in men was beta 0.06, 95% CI -13.68, 13.79, p>0.90. CONCLUSIONS: Older women and men have similarly high prevalence of LUTS. After removing women and men with prevalent CHD from the analysis, older women and men with LUTS did not have an increased 10-year risk of having CHD. Source of Funding: K24 AG073586 (PI: Markland) © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1236 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Alayne D. Markland More articles by this author Kathryn L. Burgio More articles by this author Belinda Williams More articles by this author Richard Kennedy More articles by this author Sara Elgayar More articles by this author Yue Zhang More articles by this author Virginia J. Howard More articles by this author Expand All Advertisement PDF downloadLoading ...
You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence (MP23)1 May 2024MP23-12 OPTIMIZING REMOTE ACCESS TO URINARY INCONTINENCE TREATMENTS FOR WOMEN VETERANS: A SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED MULTICENTER TRIAL Alayne D. Markland, Karen Goldstein, T. Mark Beasley, Lisa Zubkoff, Ursula Kelly, Kathryn L. Burgio, and E. Camille Vaughan Alayne D. MarklandAlayne D. Markland , Karen GoldsteinKaren Goldstein , T. Mark BeasleyT. Mark Beasley , Lisa ZubkoffLisa Zubkoff , Ursula KellyUrsula Kelly , Kathryn L. BurgioKathryn L. Burgio , and E. Camille VaughanE. Camille Vaughan View All Author Informationhttps://doi.org/10.1097/01.JU.0001008776.99097.8a.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Behavioral treatments for urinary incontinence (UI) are recommended as first-line treatment options. Yet, many women with UI do not seek treatment. To improve access to behavioral treatments for UI, we compared the effectiveness of two remote delivery modalities and assessed the effect of an additional randomized video visit for non-responders. METHODS: Nonpregnant women Veterans with UI who had email access were eligible. Recruitment took place at 3 Veterans Affairs (VA) healthcare systems. Interventions included: (1) mobile health UI application (MyHealtheBladder;MHB) with daily sessions over 8-weeks and (2) a single VA Video Connect (VVC) session delivered by trained UI providers. Randomization groups were stratified by International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short-Form scores (ICIQ-UI-SF; range 0-21; lower scores=improved UI symptoms). The primary outcome was ICIQ-UI change scores at 12-weeks. Non-responders to initial treatment at 8 weeks (ICIQ-UI change scores>2.5 points) were re-randomized to an additional VVC session or to continue current treatment. RESULTS: Of the 286 women Veterans randomized, 164 (56.4%) self-identified as Black/African American, and the mean age was 52.9±11.3 years (range 33-83). The 12-week questionnaire response rate was 70.0% (200 of 286). At 12-weeks of follow-up (Table 1), ICIQ-UI scores for the MHB group (n=100 of 147) changed by -3.6±3.9 points vs -2.3±4.0 points for the VVC group (n=100 of 139), p=0.02. At 12-weeks, ICIQ-UI scores for the MHB non-responder group re-randomized to an additional VVC (n=12) changed -1.0±2.6 points vs -1.2±3.5 points for the MBH non-responders who continued treatment (n=10), p=0.14. In the VVC non-responder group with the additional VVC (n=23), ICIQ-UI scores changed -0.9±2.8 points vs -0.3±4.2 in VVC non-responders who continued treatment (n=30), p=0.58. CONCLUSIONS: Engaging women Veterans with virtual modalities for delivery of behavioral UI treatment improved UI symptoms, with more improvement for MHB compared to VVC. Optimization of UI treatment with an additional video visit did not improve UI symptoms for non-responders. Remote delivery of UI treatments is effective for improving UI among women in the VA healthcare system. Source of Funding: Department of Veterans Affairs Health Services Research and Development HX002827 (PI: Markland); ClinicalTrials.gov number-NCT04237753 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e386 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Alayne D. Markland More articles by this author Karen Goldstein More articles by this author T. Mark Beasley More articles by this author Lisa Zubkoff More articles by this author Ursula Kelly More articles by this author Kathryn L. Burgio More articles by this author E. Camille Vaughan More articles by this author Expand All Advertisement PDF downloadLoading ...
AIMS:This paper explores Black women's perspectives on bladder health using a social-ecological conceptual framework and life course perspective.METHODS:We conducted a directed content analysis of data from the Study of Habits, Attitudes, Realities, and Experiences (SHARE), a focus group study by the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. Analysis was conducted on data from five focus groups and a member-checking session where all participants self-identified as Black or African American.RESULTS:Forty-two participants aged 11-14 or 45+ years reported life course experiences with their bladder. The intersection of race and gender was the lens through which participants viewed bladder health. Participants' accounts of their perspectives on bladder health explicitly and implicitly revealed structural racism as an explanatory overarching theme. Participants described (a) historically-rooted and still pervasive practices of discrimination and segregation, engendering inequitable access to quality medical care and public facilities, (b) institutional barriers to toileting autonomy in educational and occupational settings, promoting unhealthy voiding habits, (c) internalized expectations of Black women's stereotyped role as family caregiver, compromising caregiver health, (d) lack of reliable information on bladder health, leading to unhealthy bladder behaviors, and (e) potentially stress-related comorbid chronic conditions and associated medication use, causing or exacerbating bladder problems.CONCLUSIONS:Bladder health promotion interventions should address social-ecological and life course factors shaping Black women's bladder health, including social and structural barriers to accessing equitable health information and medical care.
BACKGROUND:Nocturia (waking from sleep at night to void) and chronic insomnia frequently co-exist in older adults, contributing synergistically to sleep disturbance. Treatments typically target either nocturia or insomnia rather than simultaneously addressing shared mechanisms for these disorders. METHODS:We conducted a multisite feasibility study to: (1) test and refine a protocol for recruitment, randomization, and assessment of older adults with co-existing nocturia and insomnia; and (2) examine preliminary changes in outcome measures to inform a future larger, multisite clinical trial. Participants were men and women aged 60 years and older recruited from outpatient clinics, reporting an average of two or more nocturia episodes per night over the past 4 weeks and meeting diagnostic criteria for chronic insomnia disorder. Participants were randomized to receive either integrated cognitive-behavioral therapy for insomnia and nocturia or a health education control program involving five weekly visits with a trained nurse practitioner interventionist. Outcomes (e.g., nocturia episodes) were measured 1-week post-treatment and 4-month post-randomization. Descriptive statistics examined the feasibility of outcomes to guide preparations for a future efficacy trial. RESULTS:Of 245 adults screened, 55% were ineligible and 25% declined to participate. Sixty-one percent of 49 participants who provided informed consent were randomized. Of the 30 participants randomized (mean age = 70.6 years, 60% White), 14 were assigned to integrated cognitive-behavioral treatment and 16 to the control group. All randomized participants provided 4-month follow-up data. At 4 months, mean nightly nocturia episodes decreased by 0.9 (SD 1.0) in the integrated treatment group and by 0.2 (SD 1.2) in the control group compared with baseline. DISCUSSION:Findings demonstrate the feasibility of recruiting, randomizing, and collecting outcome data from older adults (predominantly male) assigned to an integrated cognitive-behavioral therapy for coexisting insomnia and nocturia or a health education control program.
Women Veterans constitute a distinctive cohort whose exposure to military service can contribute to development of bladder conditions, such as urinary incontinence (UI), as they age. Behavioral therapies are recommended as first-line treatment for incontinence, yet many VA Medical Centers do not have staff trained to administer them. The purpose of this research study was to conduct a qualitative program evaluation of MyHealtheBladder, a mobile telehealth version of an evidence-based eight-week behavioral treatment program designed for women Veterans with incontinence. MyHealtheBladder uses mobile telehealth technology to teach pelvic floor muscle exercises, bladder control strategies, fluid management, risk factor reduction, and self-monitoring. Eighteen women Veterans who completed a pilot study of MyHealtheBladder participated in semi-structured telephone interviews exploring their experience with the program. A directed content analysis was conducted of the transcribed interview data. Participants described ease of accessing MyHealtheBladder using smart phones and other mobile devices, emphasizing the flexibility of using the program at home, work, or while traveling. Most participants described program content as understandable, relevant, and easy to follow. They discussed how the program increased knowledge of UI, promoted consistency in practicing behavioral therapy, strengthened pelvic floor muscles, reduced urine leakage, and improved psychosocial wellbeing. Suggestions for improvement included more interaction with staff, more individualized tailoring of content to UI type, incorporating in-person clinic visits, and including supplementary material. Participants uniformly endorsed the program and recommended it for other women Veterans, as well as for those in active duty to prevent or treat UI earlier in the life course.
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.
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.
Objective: The purpose of this analysis was to explore adolescent and adult women's interest in public health messaging around bladder health and perceptions of its usefulness. Materials and Methods: 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 across the life course. This article reports an analysis of the "Public Health Messaging" code, which included participants' desire or need for information about bladder health and recommendations for appropriate priority audiences. Results: Forty-four focus groups were conducted with 360 participants organized into six age groups (11-93 years). There was consensus across age groups that more information about the bladder is wanted and needed throughout the life course, as there is currently a lack of reliable educational resources. Information on bladder health was seen as useful and important because it enables people to anticipate negative changes in bladder health and act to prevent these. Several priority audiences were identified based on their risk of developing symptoms, but participants also saw value in educating the general public regardless of risk status. They also recommended education for parents and teachers who are in positions to control bathroom access. Conclusions: Results indicate a uniform desire for information on women's bladder health and a need for more research to develop individual prevention strategies and public health messaging for women of all ages, as well as guidance for organizations with a role in supporting bladder health.
OBJECTIVES:In this pragmatic clinical trial, the primary objective is to increase access to behavioral treatment of urinary incontinence (UI) for women Veterans by comparing the effectiveness of two virtual care delivery modalities. METHODS:Veterans Affairs (VA) clinical sites in AL, GA, NC will virtually randomize 286 women Veterans with UI (ie, stress, urge, or mixed). We will compare the effectiveness of our mHealth UI application (MyHealtheBladder) to a single VA Video Connect (VVC) session delivered by trained UI providers. Women without improvement after 8 weeks will receive an optimization VVC visit using a sequential, multiple assignment, randomized trial (SMART) design. The primary outcome is UI symptom improvement at 12-weeks with or without optimization; secondary outcomes include improvements in lower urinary tract symptoms, adherence, retention rates, perceptions of improvement, and visit-related miles saved. Sample size needed to identify a 2.5-point change (range 0-21) in the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) from baseline to 12-weeks post-randomization is 200 participants. Allowing for an attrition rate of 25%, 286 participants are required. KEY RESULTS:Study team initiated remote recruitment on April 2020. Recruitment is on target with a 75% retention rate. We expect completion in fall of 2023 (clinicaltrials.govNCT04237753). DISCUSSION/CONCLUSION:Engaging women Veterans with virtual modalities for initial UI treatment may increase access to UI care while also improving symptoms. After assessing efficacy, adherence, and retention, the next step is to implement the most effective option for remote delivery of evidence-based behavioral UI treatment for women Veterans. TRIAL REGISTRATION:ClinicalTrials.gov number NCT04237753.
BACKGROUND:Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge.OBJECTIVES:Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs.METHODS:This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials.RESULTS:Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single (P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more "denial" coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores.CONCLUSION:ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs.TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02505425.