A multisite feasibility study of integrated cognitive-behavioral treatment for co-existing nocturia and chronic insomnia.

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.

Exploring women's bladder self-care practices: A qualitative secondary analysis.

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.

Black women's perspectives on bladder health: Social-ecological and life course contexts.

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.

Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options.

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.

Preferences for Public Health Messaging Related to Bladder Health in Adolescent and Adult Women.

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.

Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse.

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.

Need for Public Health Messaging Related to Bladder Health from Adolescence to Advanced Age.

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.

African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.

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.

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

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

Perioperative Mobile Telehealth Program for Post-Prostatectomy Incontinence: A Randomized Clinical Trial.

PURPOSE: Perioperative pelvic floor muscle training can hasten recovery of bladder control and reduce severity of urinary incontinence following radical prostatectomy. Nevertheless, most men undergoing prostatectomy do not receive this training. The purpose of this trial was to test the effectiveness of interactive mobile telehealth (mHealth) to deliver an evidence-based perioperative behavioral training program for post-prostatectomy incontinence. MATERIALS AND METHODS: This was a 3-site, 2-arm, randomized trial (2014-2019). Men with prostate cancer scheduled to undergo radical prostatectomy were randomized to a perioperative behavioral program (education, pelvic floor muscle training, progressive exercises, bladder control techniques) or a general prostate cancer education control condition, both delivered by mHealth for 1-4 weeks preoperatively and 8 weeks postoperatively. The primary outcome was time to continence following surgery measured by the ICIQ (International Consultation on Incontinence Questionnaire) Short-Form. Secondary outcomes measured at 6, 9 and 12 months included Urinary Incontinence Subscale of Expanded Prostate Cancer Index Composite; pad use; International Prostate Symptom Score QoL Question and Global Perception of Improvement. RESULTS: A total of 245 men (ages 42-78 years; mean=61.7) were randomized. Survival analysis using the Kaplan-Meier estimate showed no statistically significant between-group differences in time to continence. Analyses at 6 months indicated no statistically significant between-group differences in ICIQ scores (mean=7.1 vs 7.0, p=0.7) or other secondary outcomes. CONCLUSIONS: mHealth delivery of a perioperative program to reduce post-prostatectomy incontinence was not more effective than an mHealth education program. More research is needed to assess whether perioperative mHealth programs can be a helpful addition to standard prostate cancer care.

Exploratory evaluation of baseline cognition as a predictor of perceived benefit in a study of behavioral therapy for urinary incontinence in Parkinson disease.

AIMS: While behavior-based pelvic floor muscle exercise therapy is an effective treatment for overactive bladder in Parkinson's disease (PD) patients, cognitive function may be a predictor of rehabilitation outcomes. METHODS: In a planned exploratory analysis, participants who had a Montreal Cognitive Assessment (MoCA) with a score ≥18 who were randomized in a clinical trial to behavioral treatment were classified by perceived improvement (Benefit vs. No Benefit) as reported on a validated Satisfaction and Benefit Questionnaire. General cognition (MoCA), motor procedural learning (Serial reaction time task), verbal memory (Buschke delayed recall), spatial memory (Nonverbal/Spatial selective reminding test), and working memory (Wisconsin card sorting task) were compared between the two groups using Wilcoxon rank-sum test. RESULTS: Of the 26 participants randomized to behavioral treatment (70% male, mean age 71 ± 6.1 years), 22 participants (85%) reported Benefit and four reported No Benefit. General cognition, motor procedural learning, verbal memory, spatial memory, and working memory did not differ between these groups. While the difference between the time to complete the final practiced series and the random series of the Serial Reaction Time Task (SRTT) was statistically similar between the groups, the Benefit group performed the random sequence more quickly (567.0 ± 136.5 ms) compared to the No Benefit group (959.4 ± 443.0 ms; p = 0.03) and trended toward faster performance in the final practiced series. CONCLUSIONS: Perceived benefit from behavioral treatment for overactive bladder was not associated with measures of baseline cognition other than faster completion of the SRTT. This is noteworthy because many behavior-based therapy studies exclude participants with mild cognitive impairment. Additional studies may evaluate if domain-specific cognitive function, particularly the assessment of implicit memory, could lead to individualized behavioral therapy recommendations.

Considerations for integrated cognitive behavioural treatment for older adults with coexisting nocturia and insomnia.

Nocturia and chronic insomnia disorder are common conditions that frequently coexist in older adults. Existing medication treatments for each condition have risks, particularly in older adults. While treatment guidelines recommend starting with behavioural therapy for each condition, no existing program simultaneously addresses nocturia and insomnia. Existing behavioural interventions for nocturia or insomnia contain concordant and discordant components. An expert panel (including geriatricians with sleep or nocturia research expertise, sleep psychologists and a behavioural psychologist) was convened to combine and reconcile elements of behavioural treatment for each condition. Concordant treatment recommendations involve using situational self-management strategies such as urge suppression or techniques to influence homeostatic drive for sleep. Fluid modification such as avoiding alcohol and evening caffeine and regular self-monitoring through a daily diary is also appropriate for both conditions. The expert panel resolved discordant recommendations by eliminating overnight completion of voiding diaries (which can interfere with sleep) and discouraging routine overnight voiding (a stimulus control strategy). The final product is an integrated cognitive behavioural treatment that is delivered by advanced practice providers weekly over 5 weeks. This integrated program addresses the common scenario of coexisting nocturia and chronic insomnia disorder.

Examining Adherence and Dose Effect of an Early Palliative Care Intervention for Advanced Heart Failure Patients.

CONTEXT: Research priority guidelines highlight the need for examining the "dose" components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the "dose" effect of PC intervention completion vs. noncompletion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. "Completers" defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus 6 weekly, PC nurse coach-led telehealth sessions. "Non-completers" were defined as either not attending the OPCC or completing <6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for "completers" vs "noncompleters" over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as "completers" with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. 'Completers' vs. "non-completers"" groups were well-balanced at baseline; however "noncompleters" did report higher anxiety (6.0 vs 7.0, P < 0.05, d = 0.28). Moderate, clinically significant, improved QoL differences were found at 16 weeks in "completers" vs. "non-completers" (between-group difference: -9.71 (3.18), d = 0.47, P = 0.002) but not healthcare use. CONCLUSION: Higher intervention completion rates of an early PC intervention was associated with QoL improvements in patients with advanced HF. Future work should focus on identifying the most efficacious "dose" of intervention components and increasing adherence to them. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02505425.

Comparison of Two Methods for Implementing Comfort Care Order Sets in the Inpatient Setting: a Cluster Randomized Trial.

BACKGROUND: There is an ongoing need for interventions to improve quality of end-of-life care for patients in inpatient settings. OBJECTIVE: To compare two methods for implementing a Comfort Care Education Intervention for Palliative Care Consultation Teams (PCCT) in Veterans Affairs Medical Centers (VAMCs). DESIGN: Cluster randomized implementation trial conducted March 2015-April 2019. PCCTs were assigned to a traditional implementation approach using a teleconference or to an in-person, train-the-champion workshop to prepare PCCTs to be clinical champions at their home sites. PARTICIPANTS: One hundred thirty-two providers from PCCTs at 47 VAMCs. INTERVENTIONS: Both training modalities involved review of educational materials, instruction on using an electronic Comfort Care Order Set, and coaching to deliver the intervention to other providers. MAIN MEASUREMENTS: Several processes of care were identified a priori as quality endpoints for end-of-life care (last 7 days) and abstracted from medical records of veterans who died within 9 months before or after implementation (n = 6,491). The primary endpoint was the presence of an active order for opioid medication at time of death. Secondary endpoints were orders/administration of antipsychotics, benzodiazepines, and scopolamine, do-not-resuscitate orders, advance directives, locations of death, palliative care consultations, nasogastric tubes, intravenous lines, physical restraints, pastoral care visits, and family presence at/near time of death. Generalized estimating equations were conducted adjusting for potential covariates. KEY RESULTS: Eighty-eight providers from 23 VAMCs received teleconference training; 44 providers from 23 VAMCs received in-person workshop training. Analyses found no significant differences between intervention groups in any process-of-care endpoints (primary endpoint AOR (CI) = 1.18 (0.74, 1.89). Furthermore, pre-post changes were not significant for any endpoints (primary endpoint AOR (CI) = 1.16 (0.92, 1.46). Analyses may have been limited by high baseline values on key endpoints with little room for improvement. CONCLUSION: Findings suggest the clinical effectiveness of palliative care educational intervention was not dependent on which of the two implementation methods was used. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02383173.

Social Processes Informing Toileting Behavior Among Adolescent and Adult Women: Social Cognitive Theory as an Interpretative Lens.

Little is known about social processes shaping adolescent and adult women's toileting behaviors. The "Study of Habits, Attitudes, Realities, and Experiences" (SHARE) examines adolescent and adult women's experiences related to bladder health across the life course. Forty-four focus groups with 360 participants organized by six age groups were conducted across seven sites. A transdisciplinary team used social cognitive theory as an interpretive lens across a five-stage analysis. The act of observing was identified as the overarching social process informing women's toileting behaviors in three ways: (a) observing others' toileting behavior, (b) being aware that one's own toileting behaviors are monitored by others, and (c) observing oneself relative to others. We found that underlying processes of toileting behaviors, seemingly private are, in fact, highly social. We suggest, given this social embeddedness that health promotion efforts should leverage interpersonal networks for "social norming" interventions and policies to promote healthy toileting behaviors.

An Exploratory Analysis of Tamsulosin for Overactive Bladder (OAB) in Men With Varying Voiding Symptom Burden.

OBJECTIVE: To evaluate tamsulosin (α-blocker therapy) for male overactive bladder (OAB) and to examine if indicators of concomitant benign prostatic hyperplasia are associated with OAB symptom improvement. MATERIALS AND METHODS: This was a planned, exploratory analysis of a 4-week, α-blocker (tamsulosin 0.4 mg) run-in phase of the Male Overactive Bladder Trial in Veterans (MOTIVE). Participants with urinary urgency and urinary frequency (> 8 voids/24 hours) completed bladder diaries, answered symptom questionnaires (AUA-7 SI), and had post-void residual and noninvasive uroflowmetry measurement. RESULTS: A total of 116 male Veterans aged 42-88 years with OAB participated. There were statistically significant reductions in voiding frequency (11.3 > 10.0 voids/24 hours, P < .0001), urgency scores (mean 2.5-2.2 points, P < .0001), and nightly nocturia (2.1 > 1.8, P < .001). Only baseline AUA-7 SI total and voiding subscale categories (mild, moderate, severe) were associated with significant reduction in AUA-7 SI total score. For continuous variables, only AUA-7 SI baseline total score was associated with AUA-7 SI storage symptom changes. No other baseline measures were associated with changes in urgency, frequency, or nocturia. CONCLUSION: Initiation of short course tamsulosin therapy in men was associated with statistical reduction in OAB symptoms. Baseline post-void residual, uroflow rate, and the voiding symptom subscore of the AUA-7 SI were not predictive of OAB symptom improvement with tamsulosin. These findings merits further exploration.

Toileting Behaviors and Lower Urinary Tract Symptoms: A Cross-sectional Study of Diverse Women in the United States.

Background: Toileting behaviors are increasingly recognized as factors potentially contributing to development of lower urinary tract symptoms (LUTS). Objectives: To examine adult women's toileting behaviors and LUTS across age and race/ethnicity groups and relationships between toileting behaviors and LUTS. Design: Planned secondary analysis of questionnaire data collected in a focus group study on bladder health. Settings: Questionnaires were completed at the conclusion of focus groups conducted in community settings affiliated with seven research centers across the United States. Participants: Community-living women regardless of LUTS status. Methods: Forty-four focus groups were conducted with 360 adolescent and adult cisgender women. After each focus group, participants completed questionnaires to assess toileting behaviors (Toileting Behaviors-Women's Elimination Behaviors Scale (TB-WEB)) and their experience of LUTS (Lower Urinary Tract Symptom Tool), This analysis includes quantitative data from the subgroup of 316 participants who completed the questionnaires. Results: Participants ranged in age from 18-93 years (Mean=50.2 years). A significant effect for age was found for delayed voiding behavior, reported by 76.5% of women ages 18-25 years and 21.9% of those 75+ years (p<0.001). Conversely, reports of premature voiding were lowest in the youngest and higher in the oldest three age groups (p=0.022). Racial/ethnic differences were found for three domains of toileting behavior. Black and Hispanic women expressed a stronger preference for voiding at home rather than away from home (98.9%, 93.5%, respectively) compared to White women (90.4%, p=0.041), were more likely to void prematurely (37.6%, 33.3% vs. 21.2%, p=0.048) and to crouch, squat, or stand rather than sit to void when away from home (69.9%, 58.3% vs. 41.3%, p<0.001). Four toileting behavior domains were significantly associated with LUTS. Premature voiding was associated with any bothersome LUTS (OR=2.5; 95% confidence interval [CI]=1.3-4.8) and any bothersome storage LUTS (OR=2.9; CI=1.5-5.5). Delayed voiding was associated with bothersome emptying symptoms (OR=2.8; CI=1.1-6.6). Straining to void was associated with bothersome storage symptoms (OR=2.0; CI=1.0-3.7), bothersome emptying symptoms (OR=3.7; CI=1.9-7.3), and any bothersome LUTS (OR=2.3; CI=1.2-4.3). Preference for non-sitting positions to void when away from home was associated with bothersome emptying symptoms (OR=2.5; CI=1.3-4.8) and any bothersome LUTS (OR=1.8; CI=1.0-3.2). Conclusions: These findings highlight the need for research to understand underpinnings of age and racial/ethnic differences in toileting behaviors and identify mechanisms by which toileting behaviors might influence development of LUTS over time. Understanding causal pathways is important in the development of public health interventions to encourage toileting behaviors that support bladder health.

Novel (Multilevel) Focus Group Training for a Transdisciplinary Research Consortium.

Health researchers are increasingly turning to qualitative research for a nuanced understanding of complex health phenomena. The quality and rigor of qualitative research relies on individual data collector skills, yet few guidelines exist for training multidisciplinary, multi-institution qualitative research teams. Specific guidance is needed on qualitative research practices that ensure scientific rigor by optimizing diverse experience and expertise across research centers. We describe our systematic approach to training a cohort of 15 focus group moderators from seven universities in the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium's Study of Habits, Attitudes, Realities, and Experiences (SHARE). SHARE's aim was to explore women and girls' experiences, perceptions, beliefs, knowledge, and behaviors related to bladder health and function across the life course. Drawing on adult education and action-learning best practices, a three-phase curriculum was designed to maximize moderator proficiency and qualitative research expertise. The phases involved online, interactive web-based education, in-person didactic training with experiential components, and tailored supplemental online training. Evaluative feedback was collected before, during, and after the training. Feedback was used to identify emergent training needs. This training approach may be used by transdisciplinary research teams conducting multisite research to assure qualitative research credibility and trustworthiness.

Views of Normal Bladder Function Among Women Experiencing Lower Urinary Tract Symptoms.

OBJECTIVE: To explore the perspectives of normal bladder function among women with lower urinary tract symptoms. METHODS: This was a secondary analysis of qualitative data from structured interviews with 50 adult women with lower urinary tract symptoms. A directed content analysis of the transcripts explored women's perspectives on normal bladder function. RESULTS: Participants' descriptions of "normal" took many forms and were based on several aspects of bladder function. A prominent feature of normal was that voiding occurred as a seamless process, beginning with an urge sensation, followed by voiding with ease and to completion, and then "being done." Descriptions of normal were based largely on concepts of voiding regularity, including voiding frequency, intervals, and patterns during the day and night. Another aspect of normal bladder function was the notion of having control in terms of not leaking urine, as well as the ability to hold urine and defer urination. Views of normal bladder function extended to the absence of symptoms and the impact of being symptom-free on day-to-day life, including not having to think about or worry about the bladder or limit daily activities. CONCLUSION: Women's perspectives on normal bladder function are multifaceted, reflecting attributes most salient to each individual and likely informed by their personal experience with symptoms and their influence on daily life. This work has implications for how clinicians might engage women in discussing bladder symptoms and can inform future research and public health messaging about normal bladder function.

Comorbidities, Age, and Polypharmacy Limit the Use by US Older Adults with Nocturia of the Only FDA-approved Drugs for the Symptom.

PURPOSE: The goal of this study was to determine if the US adult population with nocturia (waking from sleep at night to void) can easily take medications (desmopressin acetate) approved by the US Food and Drug Administration for nocturia. The study examined: (1) the prevalence of comorbid conditions, laboratory abnormalities, and concomitant medications that increase risk of desmopressin use; and (2) whether these factors are associated with age or nocturia frequency. METHODS: Using a cross-sectional analysis of four US National Health and Nutrition Examination Survey (NHANES) waves (2005-2012), a total of 4111 participants aged ≥50 years who reported ≥2 nightly episodes of nocturia were identified. The main outcome was frequency of contraindications and drug interactions as described in US Food and Drug Administration-approved prescribing information. These prescribing concerns were matched to examination findings, medical conditions, concomitant medications, and laboratory results of NHANES participants. The associations between prescribing concerns and nocturia severity and age groups were examined. FINDINGS: The mean participant age was 65.7 years (95% CI, 65.3-66.1), and 45.5% were male. Desmopressin prescribing concerns were present in 80.5% (95% CI, 78.0-82.9) of those ≥50 years of age with nocturia; 50.0% (95% CI, 47.0-53.0) had contraindications, and 41.6% (95% CI, 39.3-44.0) took a concomitant drug that could increase risk of low serum sodium. Desmopressin contraindications were higher with older age (P < 0.001) and present in 73.2% (95% CI, 69.3-77.1) of those ≥80 years of age. IMPLICATIONS: Using NHANES data, this study showed that older US adults with nocturia have a high prevalence of medical conditions, concomitant medications, and baseline laboratory abnormalities that likely increase the risk of potentially severe adverse side effects from desmopressin use. A medication designed and approved for a clinical symptom that is most common in older adults could not be taken by most of the older adults with the symptom.