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.

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.

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.

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.

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.

"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.

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.

Epidemiology, pathophysiology, and classification of fecal incontinence: state of the science summary for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) workshop.

In August 2013, the National Institutes of Health sponsored a conference to address major gaps in our understanding of the epidemiology, pathophysiology, and management of fecal incontinence (FI) and to identify topics for future clinical research. This article is the first of a two-part summary of those proceedings. FI is a common symptom, with a prevalence that ranges from 7 to 15% in community-dwelling men and women, but it is often underreported, as providers seldom screen for FI and patients do not volunteer the symptom, even though the symptoms can have a devastating impact on the quality of life. Rough estimates suggest that FI is associated with a substantial economic burden, particularly in patients who require surgical therapy. Bowel disturbances, particularly diarrhea, the symptom of rectal urgency, and burden of chronic illness are the strongest independent risk factors for FI in the community. Smoking, obesity, and inappropriate cholecystectomy are emerging, potentially modifiable risk factors. Other risk factors for FI include advanced age, female gender, disease burden (comorbidity count, diabetes), anal sphincter trauma (obstetrical injury, prior surgery), and decreased physical activity. Neurological disorders, inflammatory bowel disease, and pelvic floor anatomical disturbances (rectal prolapse) are also associated with FI. The pathophysiological mechanisms responsible for FI include diarrhea, anal and pelvic floor weakness, reduced rectal compliance, and reduced or increased rectal sensation; many patients have multifaceted anorectal dysfunctions. The type (urge, passive or combined), etiology (anorectal disturbance, bowel symptoms, or both), and severity of FI provide the basis for classifying FI; these domains can be integrated to comprehensively characterize the symptom. Several validated scales for classifying symptom severity and its impact on the quality of life are available. Symptom severity scales should incorporate the frequency, volume, consistency, and nature (urge or passive) of stool leakage. Despite the basic understanding of FI, there are still major knowledge gaps in disease epidemiology and pathogenesis, necessitating future clinical research in FI.

Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial.

BACKGROUND: Fecal incontinence is a devastating condition with few US Food and Drug Administration-approved pharmacologic treatment options. Loperamide and psyllium, both first-line treatments, have different mechanisms of action without any comparative data. OBJECTIVE: The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized that psyllium fiber supplementation would be more effective than loperamide for reducing fecal incontinence episodes and have fewer adverse effects. DESIGN: We conducted a randomized, double-blind, placebo-controlled crossover trial comparing loperamide (followed by psyllium) with psyllium (followed by loperamide). SETTINGS: Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate. PATIENTS: Participants included community-dwelling adults (n = 80) with at least 1 fecal incontinent episode on a 7-day bowel diary. INTERVENTION: Participants received either daily loperamide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2-week washout, participants crossed over to 4 weeks of alternate treatment. MAIN OUTCOME MEASURES: The primary outcome was the number of fecal incontinence episodes from 7-day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability. RESULTS: Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the loperamide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incontinent episodes and improved symptom severity and quality of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium. LIMITATIONS: Limitations include the washout period length and dropout rate after crossing over to the second intervention. CONCLUSIONS: Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.

Military exposure and urinary incontinence among American men.

PURPOSE: We examined the association between military exposure and urinary incontinence in American men. MATERIALS AND METHODS: Data from the National Health and Nutrition Examination Survey (NHANES) from 2005 to 2008 were merged to include 5,297 men 20 years old or older. The question, "Did you ever serve in the Armed Forces of the United States?" (yes/no) was used to assess military exposure. Urinary incontinence was categorized as any or moderate/severe urinary incontinence vs none. Because the impact of military exposure varied by age, multivariate logistic regression models were used to estimate the OR and 95% CI stratified by 3 age groups, including 55 or less, 56 to 69 and 70 years or greater. Analysis was adjusted for race/ethnicity, education, body mass index, self-reported health status, number of chronic conditions, depression and prostate conditions, the latter in men 40 years old or older. RESULTS: Overall 23% of male respondents reported military exposure. Men with military exposure were more likely to report any urinary incontinence (18.6% vs 10.4%) and moderate/severe urinary incontinence (9.0% vs 3.1%, each p <0.001) than men without military exposure. After multivariate adjustment in men 55 years old or younger those with military exposure had 3 times greater odds of urinary incontinence (OR 3.28, 95% CI 1.38-7.77). Military exposure did not increase the odds of urinary incontinence in men 56 to 69 years old (OR 0.97, 95% CI 0.44-2.18), or 70 years old or older (OR 0.91, 95% CI 0.55-1.50). CONCLUSIONS: Prior military exposure was associated with moderate/severe urinary incontinence in American men 55 years old or younger even after controlling for known risk factors. Case finding is warranted for urinary incontinence in younger men with a history of military service.

The fluctuation of nocturia in men with lower urinary tract symptoms allocated to placebo during a 12-month randomized, controlled trial.

PURPOSE: We determined the fluctuation of nocturia in a 12-month period in men with lower urinary tract symptoms. MATERIALS AND METHODS: Men with lower urinary tract symptoms were allocated to the placebo arm of the United States Department of Veterans Affairs Cooperative Studies Program Benign Prostatic Hyperplasia Study. Reported nocturia frequency using the American Urological Association Symptom Index was collected at 6 time points (2, 4, 13, 26, 39 and 52 weeks). Repeat measurements of nocturia during a 1-year period were analyzed using a generalized mixed linear model. RESULTS: Of the 305 men allocated to the placebo group 256 participants (84%) gave answers for all 6 time points. In the entire sample the mean nocturia count did not significantly vary from baseline (week 2) after adjusting for covariates (p = 0.542). However, there was considerable fluctuation in nocturia during 1 year. Of the 93 men with 3 or 4 episodes at baseline 47% had improvement and 12% had worsening at 1 year. Of the 184 men who reported 2 or greater nocturia episodes at baseline 15% reported 0 or 1 at 52 weeks. Depending on the case definition during followup the probability of nocturia progression varied between 8% and 54% while nocturia regression varied between 2% and 33%. CONCLUSIONS: Using repeat questionnaire based assessments we observed considerable fluctuation in nocturia. However, overall there was no significant increase in prevalence in a 1-year period. These findings may be reassuring to providers and patients who elect to delay interventions for nocturia.

Intervention to improve care at life's end in inpatient settings: the BEACON trial.

BACKGROUND: Widespread implementation of palliative care treatment plans could reduce suffering in the last days of life by adopting best practices of traditionally home-based hospice care in inpatient settings. OBJECTIVE: To evaluate the effectiveness of a multi-modal intervention strategy to improve processes of end-of-life care in inpatient settings. DESIGN: Implementation trial with an intervention staggered across hospitals using a multiple-baseline, stepped wedge design. PARTICIPANTS: Six Veterans Affairs Medical Centers (VAMCs). INTERVENTION: Staff training was targeted to all hospital providers and focused on identifying actively dying patients and implementing best practices from home-based hospice care, supported with an electronic order set and paper-based educational tools. MAIN MEASURES: Several processes of care were identified as quality endpoints for end-of-life care (last 7 days) and abstracted from electronic medical records of veterans who died before or after intervention (n = 6,066). Primary endpoints were proportion with an order for opioid pain medication at time of death, do-not-resuscitate order, location of death, nasogastric tube, intravenous line infusing, and physical restraints. Secondary endpoints were administration of opioids, order/administration of antipsychotics, benzodiazepines, and scopolamine (for death rattle); sublingual administration; advance directives; palliative care consultations; and pastoral care services. Generalized estimating equations were conducted adjusting for longitudinal trends. KEY RESULTS: Significant intervention effects were observed for orders for opioid pain medication (OR: 1.39), antipsychotic medications (OR: 1.98), benzodiazepines (OR: 1.39), death rattle medications (OR: 2.77), sublingual administration (OR: 4.12), nasogastric tubes (OR: 0.71), and advance directives (OR: 1.47). Intervention effects were not significant for location of death, do-not-resuscitate orders, intravenous lines, or restraints. CONCLUSIONS: This broadly targeted intervention strategy led to modest but statistically significant changes in several processes of care, indicating its potential for widespread dissemination to improve end-of-life care for thousands of patients who die each year in inpatient settings.

Urinary incontinence management costs are reduced following Burch or sling surgery for stress incontinence.

OBJECTIVE: The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence (UI) management costs at 24 months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures. STUDY DESIGN: Resources used for UI management (supplies, laundry, dry cleaning) were self-reported by 491 women at baseline and 24 months after surgery, and total out-of-pocket costs for UI management (in 2012 US dollars) were estimated. Data from the 2 surgical groups were combined to examine the change in cost for UI management over 24 months. Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test. Predictors of change in cost were examined using multivariate mixed models. RESULTS: At baseline mean (±SD) age of participants was 53 ± 10 years, and the frequency of weekly UI episodes was 23 ± 21. Weekly UI episodes decreased by 86% at 24 months (P < .001). The mean weekly cost was $16.60 ± $27.00 (median $9.39) at baseline and $4.57 ± $15.00 (median $0.10) at 24 months (P < .001), a decrease of 72%. In multivariate analyses, cost decreased by $3.38 ± $0.77 per week for each decrease of 1 UI episode per day (P < .001) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores (P < .001) and decreased 24-hour pad weight (P < .02). CONCLUSION: Following Burch or fascial sling surgery, the UI management cost at 24 months decreased by 72% ($625 per woman per year) and was strongly associated with decreasing UI frequency. Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.

IMPORTANCE: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00597935.

Association of low dietary intake of fiber and liquids with constipation: evidence from the National Health and Nutrition Examination Survey.

OBJECTIVES: Epidemiological studies support an association of self-defined constipation with fiber and physical activity, but not liquid intake. The aims of this study were to assess the prevalence and associations of dietary fiber and liquid intake to constipation. METHODS: Analyses were based on data from 10,914 adults (≥20 years) from the 2005-2008 cycles of the National Health and Nutrition Examination Surveys. Constipation was defined as hard or lumpy stools (Bristol Stool Scale type 1 or 2) as the "usual or most common stool type." Dietary fiber and liquid intake from total moisture content were obtained from dietary recall. Co-variables included: age, race, education, poverty income ratio, body mass index, self-reported general health status, chronic illnesses, and physical activity. Prevalence estimates and prevalence odds ratios (POR) were analyzed in adjusted multivariable models using appropriate sampling weights. RESULTS: Overall, 9,373 (85.9%) adults (4,787 women and 4,586 men) had complete stool consistency and dietary data. Constipation rates were 10.2% (95% confidence interval (CI): 9.6, 10.9) for women and 4.0% (95% CI: 3.2, 5.0) for men (P<.001). After multivariable adjustment, low liquid consumption remained a predictor of constipation among women (POR: 1.3, 95% CI: 1.0, 1.6) and men (POR: 2.4, 95% CI: 1.5, 3.9); however, dietary fiber was not a predictor. Among women, African-American race/ethnicity (POR: 1.4, 95% CI: 1.0, 1.9), being obese (POR: 0.7, 95% CI: 0.5,0.9), and having a higher education level (POR: 0.8, 95% CI: 0.7, 0.9) were significantly associated with constipation. CONCLUSIONS: The findings support clinical recommendations to treat constipation with increased liquid, but not fiber or exercise.

Caffeine intake and its association with urinary incontinence in United States men: results from National Health and Nutrition Examination Surveys 2005-2006 and 2007-2008.

PURPOSE: Epidemiological studies in women have revealed an association between caffeine intake and urinary incontinence, although evidence among men is limited. Therefore, we evaluated the association between caffeine intake and urinary incontinence in United States men. MATERIALS AND METHODS: Data were used from male NHANES (National Health and Nutrition Examination Surveys) 2005-2006 and 2007-2008 participants. Urinary incontinence was defined using a standard questionnaire with Incontinence Severity Index scores 3 or greater categorized as moderate to severe. Structured dietary recall was used to determine caffeine consumption (mg per day), water intake (gm per day) and total dietary moisture (gm per day). Stepwise multivariable logistic regression models were used to assess the association between caffeine intake at or above the 75th and 90th percentiles and moderate to severe urinary incontinence, controlling for potential confounders, urinary incontinence risk factors and prostate conditions in men age 40 years or older. RESULTS: Of the 5,297 men 3,960 (75%) were 20 years old or older with complete data. Among these men the prevalence of any urinary incontinence was 12.9% and moderate to severe urinary incontinence was 4.4%. Mean caffeine intake was 169 mg per day. Caffeine intake at the upper 75th percentile (234 mg or more daily) and 90th percentile (392 mg or more per day) was significantly associated with having moderate to severe urinary incontinence (1.72, 95% 1.18-2.49 and 2.08, 95% 1.15-3.77, respectively). In addition, after adjusting for prostate conditions, the effect size for the association between caffeine intake and moderate to severe urinary incontinence remained. CONCLUSIONS: Caffeine consumption equivalent to approximately 2 cups of coffee daily (250 mg) is significantly associated with moderate to severe urinary incontinence in United States men. Our findings support the further study of caffeine modification in men with urinary incontinence.

Efficacy of adding behavioural treatment or antimuscarinic drug therapy to α-blocker therapy in men with nocturia.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Nocturia is a common and bothersome lower urinary tract symptom, particularly in men. Many single drug therapies have limited benefit. For men who have persistent nocturia despite alpha-blocker therapy, the addition of behavioural and exercise therapy is statistically superior to anticholinergic therapy. OBJECTIVE: To compare reductions in nocturia resulting from adding either behavioural treatment or antimuscarinic drug therapy to α-adrenergic antagonist (α-blocker) therapy in men. PATIENTS AND METHODS: Participants were men who had continuing urinary frequency >8 voids/day) and urgency after 4 weeks of α-blocker therapy run-in and who had ≥1 nightly episode of nocturia. Participants received individually titrated drug therapy (extended-release oxybutynin) or multicomponent behavioural treatment (pelvic floor muscle training, delayed voiding and urge suppression techniques). Seven-day bladder diaries were used to calculate reductions in mean nocturia. RESULTS: A total of 127 men aged 42-88 years with ≥1 nocturia episode per night were included in the study. There were 76 men who had a mean of ≥2 nocturia episodes. Among those with ≥1 nocturia episode, behavioural treatment reduced nightly nocturia by a mean of 0.97 episodes and was significantly more effective than drug therapy (mean reduction = 0.56 episodes; P = 0.01). Participants with ≥2 episodes nocturia at baseline also showed larger changes with behavioural treatment compared with antimuscarinic therapy (mean reduction = 1.26 vs 0.61; P = 0.008). CONCLUSIONS: Both behavioural treatment and drug therapy reduced nocturia in men with ≥1 episode of nocturia/night when added to α-blocker therapy. These results were similar even when only those with ≥2 episodes of nocturia were considered. The addition of behavioural treatment was statistically better than bladder-relaxant therapy for nocturia.