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.

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.

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.

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.

"Online Training Is Great but Human Interaction Is Better": Training Preferences of VA Interdisciplinary Palliative Care Consult Teams.

A growing body of research has examined modalities for delivering palliative care education; however, we know little about education and training preferences of VA interdisciplinary Palliative Care Consult Teams (PCCT). In the BEACON II study, we explored training preferences of PCCTs from 46 Veterans Affairs Medical Centers (VAMCs) participating in either a multisite webinar or a small group, in-person workshop. We interviewed participants by telephone seven to eight month post-training. In all, 75.9% preferred in-person education and training, including 78.9% of workshop participants and 73.1% of webinar participants. Respondents described in-person training as fostering learning through the following processes: (1) active engagement and focus, (2) interaction and networking, (3) meaning-making and relevance, and (4) reciprocity and commitment. Although it is not possible for Web-based palliative care education programs to replicate all aspects of the in-person learning experience, building experiential, interactive, meaningful, and reciprocal components into Web-based education may help shift preferences and make interdisciplinary team-based palliative care education accessible to a larger audience.

Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.

Importance: First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative. Objective: To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy. Design, Setting, and Participants: In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019. Interventions: Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg). Main Outcomes and Measures: Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score. Results: Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures. Conclusions and Relevance: Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone. Trial Registration: ClinicalTrials.gov identifier: NCT01175382.

A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder.

AIM: To develop and pilot test an interactive mobile telehealth program (mHealth) for behavioral treatment of women veterans with urinary incontinence (UI). METHODS: We developed an evidence-based 8-week behavioral mHealth program, MyHealtheBladder, with input from women veterans, behavioral medicine and health education experts, and clinical providers treating UI in the VA system. The program was story-based and included pelvic floor muscle exercises, bladder control strategies, fluid management, risk factor reduction, and self-monitoring. Participants were women veterans seeking outpatient treatment for UI occurring at least twice weekly. The primary efficacy estimate was the change in UI frequency, volume and impact on the quality of life as measured by the validated International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range: 0-21, 2.5 points for minimal clinically important difference [MCID]). RESULTS: We enrolled 29 women veterans (ages 29-77 years; mean = 54.4 ± 10.4), including 15 (52%) African-American women, 13 (45%) women with high school education, and 16 (55%) with a college degree. Twenty of 29 women (69%) completed all 8 weeks of the intervention with a 97% adherence rate to the daily sessions among completers. We found reductions in ICIQ-SF scores from a mean 12.6 ± 3.9 at baseline to 10.4 ± 4.11 at 5 weeks, to 8.7 ± 4.0 at the end of the 8-week intervention. CONCLUSIONS: Women veterans using an 8-week behavioral mHealth program for the treatment of UI had symptom improvements that exceeded the MCID for the ICIQ-SF. Our next step involves comparing the effectiveness of MyHealtheBladder to usual care in a larger clinical trial.

Behavioral therapy for urinary symptoms in Parkinson's disease: A randomized clinical trial.

AIM: Determine the efficacy of behavioral therapy for urinary symptoms in Parkinson's disease. METHODS: Randomized trial of behavioral therapy compared with control condition among adults (aged 54-85 years, 74% male, 10% Black/ 83% White) with Parkinson's and greater than or equal to 4 incontinence episodes weekly. Behavioral therapy included pelvic floor muscle exercises, bladder training, fluid and constipation management. Both groups completed bladder diary self-monitoring. Outcomes included diary-derived incontinence and ICIQ-overactive bladder (OAB) score (range, 0-16) with bother and quality of life questionnaires (higher scores = worse outcomes). RESULTS: Fifty-three participants randomized and 47 reported 8-week outcomes including 26 behavioral therapy and 21 control. Behavioral vs control participants were similar with respect to age (71.0 ± 6.1 vs 69.7 ± 8.2 years), sex (70% vs 78% male), motor score, cognition, mean weekly incontinence episodes (13.9 ± 9.6 vs 15.1 ± 11.1) and OAB symptoms (8.9 ± 2.4 vs 8.3 ± 2.2). Weekly incontinence reduction was similar between behavioral (-6.2 ± 8.7) and control participants (-6.5 ± 13.8) (P = 0.89). After multiple imputation analysis, behavioral therapy participants reported statistically similar reduction in OAB symptoms compared to control (-3.1 ± 2.8 vs -1.9 ± 2.2, P = 0.19); however quality of life (-22.6 ± 19.1 vs -7.0 ± 18.4, P = 0.048) and bother (-12.6 ± 17.2 vs - 6.7 ± 8.8, P = 0.037) improved significantly more with behavioral therapy. CONCLUSION: Self-monitoring resulted in fewer urinary symptoms; however, only multicomponent behavioral therapy was associated with reduced bother and improved quality of life. Providers should consider behavioral therapy as initial treatment for urinary symptoms in Parkinson's disease.

Terminology for bladder health research in women and girls: Prevention of Lower Urinary Tract Symptoms transdisciplinary consortium definitions.

AIM: To report research terminology and definitions for describing healthy bladder function among women and girls. METHODS: The Prevention of Lower Urinary tract Symptoms (PLUS) Consortium developed research terminology and definitions for elements of healthy bladder function based on existing understanding of storage and emptying functions of the bladder and accepted definitions of lower urinary tract symptoms (LUTS). The novel concept of a bladder "bioregulatory" function was also proposed. Elements of bladder function corresponding to bladder health (BH) and LUTS were developed and refined using an iterative process. A comprehensive reference table structured by bladder function (Storage, Emptying, and Bioregulatory) and elements of each function was created to document proposed research terminology and definitions. RESULTS: The BH research definitions for each bladder function are: (1) Storage: the ability to hold urine for a reasonable duration of time and sense bladder fullness without fear of or concern about urgency, discomfort or leakage; (2) Emptying: the ability to empty the bladder completely in a timely, efficient, effortless, comfortable manner; and (3) Bioregulatory: the bladder barrier protects the individual/host from pathogens, chemicals, and malignancy. Research definitions for seven Storage, seven Emptying, and three Bioregulatory elements of function are presented. Novel LUTS research definitions were developed when gaps in existing definitions were identified or nonclinical language was desired. CONCLUSIONS: PLUS BH definitions reflect a transdisciplinary approach to standardizing research definitions for elements of bladder function from a perspective of health rather than dysfunction and provide a framework for studying BH in clinical practice, public health promotion, and LUTS prevention.

Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study.

OBJECTIVES: To estimate the efficacy of vitamin D supplementation to reduce urgency urinary incontinence (UUI) episodes. DESIGN: Pilot, two-arm, randomized trial conducted from 2013 to 2017. Interventions were 12 weeks of weekly oral 50,000 IU vitamin D3 or placebo. SETTING: Academic, university-based outpatient clinic. PARTICIPANTS: Community-dwelling postmenopausal women, 50 years or older, with at least three UUI episodes on 7-day bladder diary and serum vitamin 25-hydroxyvitamin D (25[OH]D) of 30 ng/mL or less. MEASUREMENTS: The primary efficacy estimate was the percentage change in UUI episodes. Secondary estimates included changes in other lower urinary tract symptoms, along with exploratory subgroup analysis by race/ethnicity and obesity. RESULTS: We randomized 56 women (aged 50-84 years; mean = 60.5 ± 8.2 years), 28 to vitamin D and 28 to placebo; 51 completed treatments. Mean serum 25(OH)D at baseline (21.2 ± 5.2 and 18.2 ± 5.6, P = .30) improved to 57.9 ± 16.3 ng/mL with vitamin D3 and 21.9 ± 8.2 ng/mL with placebo (P < .001). UUI episodes per 24-hour day decreased by 43.0% with vitamin D3 compared to 27.6% with placebo (P = .22). Among black women (n = 33), UUI episodes decreased by 63.2% with vitamin D3 compared to 22.9% with placebo (P = .03). Among obese women, UUI episodes decreased by 54.1% with vitamin D compared to 32.7% with placebo (P = .29). For all women, changes in voiding frequency (P = .40), nocturia (P = .40), urgency (P = .90), incontinence severity (P = .81), and overactive bladder symptom severity (P = .47) were not different between arms. CONCLUSIONS: Postmenopausal women with UUI and vitamin D insufficiency demonstrated a greater than 40% decrease in UUI episodes, which did not reach statistical significance compared to placebo, except in the subset of black women. The results of this pilot study support further investigation of vitamin D3 alone or in combination with other treatments for UUI, particularly for women in higher-risk subgroups. J Am Geriatr Soc 67:570-575, 2019.

Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial.

Importance: Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment. Objective: To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women. Design, Setting, and Participants: Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), symptoms of at least 3 months' duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study. Interventions: The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD. Main Outcomes and Measures: Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment. Results: Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, -1.51 to -0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months. Conclusions and Relevance: The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI. Trial Registration: ClinicalTrials.gov identifier: NCT02001714.

The Prevention of Lower Urinary Tract Symptoms (PLUS) in girls and women: Developing a conceptual framework for a prevention research agenda.

AIMS: The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium was established by the National Institutes of Health in 2015 to expand research beyond the detection and treatment of lower urinary tract symptoms (LUTS) to the promotion and preservation of bladder health and prevention of LUTS in girls and women. While many multi-disciplinary scientific networks focus on pelvic floor dysfunction and LUTS, the PLUS Consortium stands alone in its focus on prevention. This article describes the PLUS approach to developing a conceptual framework to guide the Consortium's initial prevention research agenda. METHODS: The conceptual framework was informed by traditional social ecological models of public health, biopsychosocial models of health, Glass and McAtee's Society-Behavior-Biology Nexus, and the World Health Organization's conceptual framework for action on the social determinants of health. RESULTS: The PLUS conceptual framework provides a foundation for developing prevention interventions that have the greatest likelihood of promoting and preserving bladder health among diverse populations. CONCLUSIONS: PLUS Consortium work is premised on the notion that programs, practices, and policies designed to promote health will have optimal impact if the conceptual foundation upon which efforts are based is comprehensive and informed by multiple disciplines. The PLUS conceptual framework is broadly applicable to domains of health that have historically focused on the treatment of illness and symptoms rather than the promotion of health. It is also applicable to domains of health that have been examined from a predominantly biological or social ecological perspective, without integration of both perspectives.

A Novel Research Definition of Bladder Health in Women and Girls: Implications for Research and Public Health Promotion.

BACKGROUND: Bladder health in women and girls is poorly understood, in part, due to absence of a definition for clinical or research purposes. This article describes the process used by a National Institutes of Health funded transdisciplinary research team (The Prevention of Lower Urinary Tract Symptoms [PLUS] Consortium) to develop a definition of bladder health. METHODS: The PLUS Consortium identified currently accepted lower urinary tract symptoms (LUTS) and outlined elements of storage and emptying functions of the bladder. Consistent with the World Health Organization's definition of health, PLUS concluded that absence of LUTS was insufficient and emphasizes the bladder's ability to adapt to short-term physical, psychosocial, and environmental challenges for the final definition. Definitions for subjective experiences and objective measures of bladder dysfunction and health were drafted. An additional bioregulatory function to protect against infection, neoplasia, chemical, or biologic threats was proposed. RESULTS: PLUS proposes that bladder health be defined as: "A complete state of physical, mental, and social well-being related to bladder function and not merely the absence of LUTS. Healthy bladder function permits daily activities, adapts to short-term physical or environmental stressors, and allows optimal well-being (e.g., travel, exercise, social, occupational, or other activities)." Definitions for each element of bladder function are reported with suggested subjective and objective measures. CONCLUSIONS: PLUS used a comprehensive transdisciplinary process to develop a bladder health definition. This will inform instrument development for evaluation of bladder health promotion and prevention of LUTS in research and public health initiatives.

Cluster analysis of multiple chronic conditions associated with urinary incontinence among women in the USA.

OBJECTIVE: To identify patterns of prevalent chronic medical conditions among women with urinary incontinence (UI). MATERIALS AND METHODS: We combined cross-sectional data from the 2005-2006 to 2011-2012 US National Health and Nutrition Examination Surveys, and identified 3 800 women with UI and data on 12 chronic conditions. Types of UI included stress UI (SUI), urgency UI (UUI), and mixed stress and urgency UI (MUI). We categorized UI as mild, moderate or severe using validated measures. We performed a two-step cluster analysis to identify patterns between clusters for UI type and severity. We explored associations between clusters by UI subtype and severity, controlling for age, education, race/ethnicity, parity, hysterectomy status and adiposity in weighted regression analyses. RESULTS: Eleven percent of women with UI had no chronic conditions. Among women with UI who had at least one additional condition, four distinct clusters were identified: (i) cardiovascular disease (CVD) risk-younger; (ii) asthma-predominant; (iii) CVD risk-older; and (iv) multiple chronic conditions (MCC). In comparison to women with UI and no chronic diseases, women in the CVD risk-younger (age 46.7 ± 15.8 years) cluster reported the highest rate of SUI and mild UI severity. In the asthma-predominant cluster (age 51.5 ± 10.2 years), women had more SUI and MUI and more moderate UI severity. Women in the CVD risk-older cluster (age 57.9 ± 13.4 years) had the highest rate of UUI, along with more severe UI. Women in the MCC cluster (age 61.0 ± 14.8 years) had the highest rates of MUI and the highest rate of moderate/severe UI. CONCLUSIONS: Women with UI rarely have no additional chronic conditions. Four patterns of chronic conditions emerged with differences by UI type and severity. Identification of women with mild UI and modifiable conditions may inform future prevention efforts.

"They Said on the Death Certificate But Really What I Think Happened": Characterizing Cause of Death in VA Medical Centers.

Cause of death information is a vital resource for family and public health, yet significant issues persist regarding its determination, documentation and communication. In this study, we aim to characterize cause of death attribution process from the perspective of next-of-kin of Veterans who died in Veterans Affairs (VA) Medical Centers. Using a semi-structured guide, we explored next-of-kin's experiences of the Veteran's terminal hospitalization and conducted a content analysis of interview texts. In over two-third of cases next-of-kin's understanding was not consistent with their recollection of physicians' determination of cause of death. Discrepancies between official cause of death and lay understanding engendered confusion and distress. Findings have relevance for shaping the context of post-death patient/family-centered clinical practice and serve as a means for improving efficacy of cause of death communication and reducing potential for misunderstandings.

Increased odds of bladder and bowel symptoms in early Parkinson's disease.

AIMS: To compare the prevalence of urinary and bowel symptoms in a sample of adults with early Parkinson's disease (PD) and healthy controls (HC). METHODS: Data were obtained from the Michael J. Fox Parkinson's Progression Markers Initiative (PPMI). Prevalent bladder (urinary incontinence (UI) and nighttime voiding) and bowel (constipation and fecal incontinence (FI)) symptoms were defined as occurring at least sometimes when queried using the Scale for Outcomes in PD for Autonomic Symptoms. RESULTS: The proportion of men (65% vs 64%) and the mean age (61.0 ± 9.7 vs 60.2 ± 11.2 years) was similar between early PD (n = 423) and HC (n = 195). UI and constipation were more prevalent among early PD versus HC (UI: 26.7% vs 8.2%, constipation: 32.4% vs 11.8%; P's < 0.0001). Prevalent nighttime voiding was high among both groups, but not significantly different (82.5% vs 84.1%, P = 0.62). FI was infrequent in both. The odds of UI and constipation were significantly higher in early PD even after adjustment for age, sex, cognition, and overactive bladder (UI model only), constipation (UI and constipation models only), depression, and anxiety medication usage (UI: OR: 4.39 [95% CI: 2.92, 5.87]; constipation: 3.34 [2.20, 4.42]; P's < 0.0001). CONCLUSIONS: While constipation is known to precede PD diagnosis, these data suggest that the occurrence of UI is elevated in early PD compared to a well-matched HC population.

Continuation of non-essential medications in actively dying hospitalised patients.

OBJECTIVE: The objective of this analysis was to examine the use of 11 non-essential medications in actively dying patients. METHODS: This was a planned secondary analysis of data from the Best Practices for End-of-Life Care for Our Nation's Veterans trial, a multicentre implementation trial of an intervention to improve processes of end-of-life care in inpatient settings. Supported with an electronic comfort care decision support tool, intervention included training hospital staff to identify actively dying patients, communicate the prognosis to patients/families and implement best practices of traditionally home-based hospice care. Data on medication use before and after intervention were derived from electronic medical records of 5476 deceased veterans. RESULTS: Five non-essential medications, clopidogrel, donepezil, glyburide, metformin and propoxyphene, were ordered in less than 5% of cases. More common were orders for simvastatin (15.8%/15.1%), calcium tablets (8.4%/7.9%), multivitamins (11.6%/10.8%), ferrous sulfate (9.1%/7.6%), diphenhydramine (7.2%/5.1%) and subcutaneous heparin (29.9%/27.5%). Significant decreases were found for donepezil (2.5%/1.3%; p=0.001), propoxyphene (0.8%/0.1%; p=0.001), metformin (0.8%/0.3%; p=0.007) and multivitamins (11.6%/10.8%; p=0.01). Orders for one or more non-essential medications were less likely to occur in association with palliative care consultation (adjusted OR (AOR)=0.64, p<0.001), do-not-resuscitate orders (AOR=0.66, p=0.001) and orders for death rattle medication (AOR=0.35, p<0.001). Patients who died in an intensive care unit were more likely to receive a non-essential medication (AOR=1.60, p=0.009), as were older patients (AOR=1.12 per 10 years, p=0.002). CONCLUSIONS: Non-essential medications continue to be administered to actively dying patients. Discontinuation of these medications may be facilitated by interventions that enhance recognition and consideration of patients' actively dying status.

Psychometric evaluation of an online and paper accidental bowel leakage questionnaire: The ICIQ-B questionnaire.

AIMS: To evaluate the psychometric properties of an online versus paper US-English version of the International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B). METHODS: The ICIQ-B includes 17 items under 3 domains: bowel pattern (5 items), bowel control (7 items), and quality of life (5 items). We recruited community-dwelling adults seeking treatment for ≥monthly bowel leakage from specialty clinics within a VA medical center and university affiliate. An online versus paper version was evaluated at baseline, 2 weeks later, and 3 months after nonsurgical treatments per usual care. We assessed test-retest reliability (Pearson correlations) at 2 weeks, internal consistency (Cronbach's alpha), and convergent validity (Pearson correlations). Sensitivity to change was the difference between the baseline and post-treatment (3-month) scores. RESULTS: Mean age was 58.0 ± 11.9; 36% Veterans, 52% women. At baseline, 2 weeks, and 3 months, we found no differences in the online vs paper scores for the bowel control and quality of life domains. The ICIQ-B demonstrated fair internal consistency for the bowel pattern domain (Cronbach's α = 0.36-0.54). Internal consistency on the bowel pattern domain was better with the paper version than the online version at 2 weeks (P < 0.05) and 3 months (P < 0.01) with no difference at baseline. All other domains had good internal consistency (Cronbach's α > 0.80), good retest reliability (r ≥ 0.70, P < 0.001), domain-specific convergent validity for stool consistency (P < 0.05), incontinence severity (P ≤ 0.002), and quality of life impact (P < 0.05). After nonsurgical treatments, we found a reasonable response to change (P ≤ 0.05). CONCLUSIONS: Online and paper versions had robust psychometric data for use among U.S. men and women, including Veterans. Neurourol. Urodynam. 36:166-170, 2017. © 2015 Wiley Periodicals, Inc.

Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep.

PURPOSE: Nocturia and sleep problems are common in older adults. We developed and tested a novel intervention, multicomponent behavioral treatment and exercise therapy (M-BET), that may reduce nocturia and improve sleep in men. We compared reductions in nocturia and improvement in sleep in men with M-BET versus an active drug comparator (α-blocker) used alone or in combination (M-BET + α-blocker) METHODS: This randomized, controlled trial was conducted in the ambulatory setting in 2 US Department of Veterans Affairs medical centers in men at least 40 years of age with nocturia (defined as ≥2 nightly episodes). Participants were randomized to receive either M-BET, including pelvic floor muscle training, urge-suppression techniques, delayed voiding, fluid management, sleep hygiene, and peripheral edema management; an active comparator of known efficacy (the α-blocker tamsulosin, one 0.4-mg tablet nightly); or both therapies combined. Participants received interventions over 12 weeks. Outcomes were assessed via voiding diaries, wrist actigraphy, and validated questionnaires. The primary outcome was change in diary-recorded nocturia, assessed using ANCOVA for the between-group changes and paired t tests for within-group changes. FINDINGS: A total of 72 men with a mean age of 65.8 years participated. At 12 weeks, mean diary-recorded nocturia changed with M-BET by -1.39 episodes/night (P < 0.001), with α-blocker therapy by -0.59 episodes/night (P < 0.01), and with combination therapy by -1.03 episodes/night (P < 0.01). Reductions were not statistically different across treatment groups (P = 0.41). M-BET also showed statistically significant improvements in sleep quality, bother from nocturia, and nocturia-specific quality of life. All treatment groups indicated global satisfaction with treatment. IMPLICATIONS: Behavioral therapy in men, alone or combined with α-blocker therapy, consistently showed large and statistically significant nocturia reductions and favorable effects on sleep and quality of life. Based on these findings, behavioral therapy, while not statistically superior to α-blocker therapy, may provide a meaningful treatment option for men with nocturia. Future research should include the development of behavioral treatment and exercise therapy interventions that could be more easily deployed. ClinicalTrials.gov identifier: NCT00824200.