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.

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.

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.

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.

Low-dose 17-ß-estradiol cream for vaginal atrophy in a cohort without prolapse: Serum levels and vaginal response including tissue biomarkers associated with tissue remodeling.

OBJECTIVES: Describe the effect of 50 mcg vaginal 17-ß-estradiol (E2) cream on vaginal maturation, serum estrogen levels, atrophic symptoms, and biomarkers of oxidative stress and tissue remodeling in postmenopausal women without prolapse. METHODS: Seventeen women, 65 years or older, applied intravaginal E2 cream nightly for eight weeks, then twice weekly for eight weeks. Vaginal biopsies, serial blood draws, and atrophic symptoms were obtained at baseline, eight, and sixteen weeks. Changes in atrophic symptoms, vaginal maturation indices (VMI), and serum E2 were measured. Immunohistochemical staining characterized levels of transforming growth factor-beta (TGF-ß), nuclear factor kappa B (NFKB), inducible nitric oxide synthase (iNOS), endothelial nitric oxide synthase (eNOS), and thrombospondin (TSP). RESULTS: Serum E2 levels (pg/ml) were unchanged from baseline (mean (SD)) 7.7 (3.3) to eight 9.7 (5.7) and sixteen 8.7 (5.8) (p=0.24) weeks. VMI (mean (SD)) improved from baseline 34.2 (18.3) to eight 56.7 (13.1) and sixteen 54.5 (11.3) (p<0.001) weeks with no difference between eight and sixteen weeks. Vaginal dryness (p=0.03) and itching (p=0.02) improved. Tissue biomarker levels did not change (TGF-ß p=0.35, NFKB p=0.74, eNOS p=0.80, iNOS p=0.24, TSP p=0.80). DISCUSSION: Vaginal E2 improved atrophic symptoms and VMI without elevating serum E2. Tissue remodeling biomarkers did not change.

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

IMPORTANCE: For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE: To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS: Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES: Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS: A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were $3.37 per day and $716 per patient. CONCLUSIONS AND RELEVANCE: This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01415934.

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.

Medication effects on periurethral sensation and urethral sphincter activity.

AIM: The aim of this study was to characterize urethral neuromuscular function before and 2 weeks after medication therapy. METHODS: Premenopausal women without lower urinary tract symptoms were randomly allocated to 1 of the 6 medications for 2 weeks (pseudoephedrine ER of 120 mg, imipramine of 25 mg, cyclobenzaprine of 10 mg, tamsulosin of 0.4 mg, solifenacin of 5 mg, or placebo). At baseline and after medication, participants underwent testing: quantitative concentric needle electromyography (CNE) of the urethral sphincter using automated multimotor unit action potential software, current perception threshold (CPT) testing to measure periurethral sensation, and standard urodynamic pressure flow studies (PFS). Nonparametric tests were used to compare pre-post differences. RESULTS: Fifty-six women had baseline testing, 48 (85.7%) completed follow-up CNE, and 49 (87.5%) completed follow-up CPT and PFS testing. Demographics showed no significant differences among medication groups with respect to age (mean, 34.3; SD, 10.1), body mass index (mean, 31.8; SD, 7.5), parity (median, 1; range, 0-7), or race (14% Caucasian, 80% African American). The PFS parameters were not significantly different within medication groups. No significant pre-post changes in CNE values were noted; however, trends in amplitudes were in a direction consistent with the expected physiologic effect of the medications. With CPT testing, a trend toward increased urethral sensation at the 5-Hz stimulation level was observed after treatment with pseudoephedrine (0.15-0.09 mA at 5 Hz, P = 0.03). CONCLUSIONS: In women without lower urinary tract symptoms, pseudoephedrine improved urethral sensation but not urethral neuromuscular function on CNE or PFS. Imipramine, cyclobenzaprine, tamsulosin, solifenacin, and placebo did not change urethral sensation or neuromuscular function.

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.

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.

Vitamin D and lower urinary tract symptoms among US men: results from the 2005-2006 National Health and Nutrition Examination Survey.

OBJECTIVE: To evaluate the association of vitamin D levels and lower urinary tract symptoms (LUTS) among US men. MATERIAL AND METHODS: Data were analyzed for 2387 men (≥20 years) who participated in the 2005-2006 cycle of the National Health and Nutrition Examination Survey, a cross-sectional survey of the US noninstitutionalized population. LUTS included nocturia, incomplete emptying, hesitancy, and urinary incontinence (UI). Plasma 25-hydroxyvitamin D was categorized as ≥30 ng/mL (normal), 20-30 ng/mL (insufficiency), and <20 ng/mL (deficiency). Other factors included age, race/ethnicity, education, body mass index, self-reported health status, chronic diseases, and prior diagnosis of benign prostatic enlargement and/or prostate cancer (men ≥40 years of age). Prevalence and prevalence odds ratios (POR) were estimated from a multivariable logistic regression analysis using appropriate sampling weights. RESULTS: A majority (89%, n = 1241) had vitamin D levels <30 ng/mL, of whom 55% (n = 684) had vitamin D levels <20 ng/mL. Vitamin D levels ranged from 2-56 ng/mL (median 19 ng/mL, mean ± SD 19.9 ± 8.0). Among the 1388 (58%) men with LUTS data and vitamin D levels, 48% (n = 666) had at least 1 LUTS. In multivariable analyses adjusting for age and race norms, vitamin D deficiency was associated with the presence of moderate-severe UI (POR 1.8, 95% CI 1.1, 3.0) and at least 1 LUTS (POR 1.4, 95% CI 1.0, 2.0). CONCLUSION: Vitamin D insufficiency and deficiency are highly prevalent among adult men in the US, and vitamin D deficiency is associated with moderate-severe UI and the presence of at least 1 LUTS.

Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial.

CONTEXT: Although behavioral therapy has been shown to improve postoperative recovery of continence, there have been no controlled trials of behavioral therapy for postprostatectomy incontinence persisting more than 1 year. OBJECTIVE: To evaluate the effectiveness of behavioral therapy for reducing persistent postprostatectomy incontinence and to determine whether the technologies of biofeedback and pelvic floor electrical stimulation enhance the effectiveness of behavioral therapy. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized controlled trial involving 208 community-dwelling men aged 51 through 84 years with incontinence persisting 1 to 17 years after radical prostatectomy was conducted at a university and 2 Veterans Affairs continence clinics (2003-2008) and included a 1-year follow-up after active treatment. Twenty-four percent of the men were African American; 75%, white. INTERVENTIONS: After stratification by type and frequency of incontinence, participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office, dual-channel electromyograph biofeedback and daily home pelvic floor electrical stimulation at 20 Hz, current up to 100 mA (behavior plus); or delayed treatment, which served as the control group. MAIN OUTCOME MEASURE: Percentage reduction in mean number of incontinence episodes after 8 weeks of treatment as documented in 7-day bladder diaries. RESULTS: Mean incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44%-66%) after behavioral therapy and from 26 to 12 (51% reduction; 95% CI, 37%-65%) after behavior plus therapy. Both reductions were significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10%-39%) observed among controls (P = .001 for both treatment groups). However, there was no significant difference in incontinence reduction between the treatment groups (P = .69). Improvements were durable to 12 months in the active treatment groups: 50% reduction (95% CI, 39.8%-61.1%; 13.5 episodes per week) in the behavioral group and 59% reduction (95% CI, 45.0%-73.1%; 9.1 episodes per week) in the behavior plus group (P = .32). CONCLUSIONS: Among patients with postprostatectomy incontinence for at least 1 year, 8 weeks of behavioral therapy, compared with a delayed-treatment control, resulted in fewer incontinence episodes. The addition of biofeedback and pelvic floor electrical stimulation did not result in greater effectiveness. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00212264.

Prevalence of nocturia in United States men: results from the National Health and Nutrition Examination Survey.

PURPOSE: We estimated the prevalence of nocturia in the United States male population and identified associated factors. MATERIALS AND METHODS: Data were analyzed for 5,297 men (20 years old or older) who participated in the 2005-2006 and 2007-2008 cycles of the NHANES, a cross-sectional survey of the United States noninstitutionalized population. Getting up 2 or more times at night to urinate was coded as nocturia. Potential factors included age, race/ethnicity, education, waist circumference, self-reported health status, chronic diseases, and prior diagnosis of benign prostatic enlargement and/or prostate cancer (men 40 years old or older). Prevalence and prevalence odds ratios were estimated from a multivariable logistic regression analysis using appropriate sampling weights. RESULTS: The prevalence of nocturia was 21% (weighted 95% CI 19.3-23.0). Nocturia increased in prevalence with age (p<0.001) from 8.2% (CI 6.7-10.2) in men 20 to 34 years old up to 55.8% (CI 51.3-60.2) in men 75 years old or older. More nonHispanic black men had nocturia (30.2%, CI 26.7-34.1) than other racial/ethnic groups (20.1%, CI 18.1-22.1, p<0.001). Significant factors included 10-year increase in age (POR 1.5, CI 1.5-1.6), nonHispanic black race/ethnicity (POR 2.0, CI 1.6-2.7), fair/poor self-rated health (POR 1.5, CI 1.2-1.9), major depression (POR 2.5, CI 1.6-3.9), hypertension (POR 1.4, CI 1.0-1.9) and arthritis (POR 1.3, CI 1.0-1.7). Among men 40 years old or older benign prostatic enlargement (POR 1.4, CI 1.1-1.8) and prostate cancer (POR 1.6, CI 1.0-2.4) were associated with nocturia. CONCLUSIONS: After adjusting for age and race norms nocturia was common among United States men. NonHispanic black men had greater odds of nocturia even when controlling for other factors.

Prevalence of urinary incontinence in men: results from the national health and nutrition examination survey.

PURPOSE: We estimated the prevalence of urinary incontinence in the United States adult male population and identified associated factors. MATERIALS AND METHODS: Data were analyzed for 5,297 men 20 years old or older who participated in the 2005 to 2006 and 2007 to 2008 cycles of the National Health and Nutrition Examination Survey, a cross-sectional, nationally representative survey of the United States noninstitutionalized population. Urinary incontinence (score of 3 or greater on a validated incontinence severity index, indicating moderate to severe leakage) was assessed. Potential associated factors included age, race/ethnicity, education, self-reported health status, prior diagnosis of prostate cancer and/or enlarged prostate (men 40 years old or older), chronic diseases and depression status. Prevalence ORs were estimated from a multivariable logistic regression analysis using appropriate sampling weights. RESULTS: The prevalence of moderate/severe urinary incontinence was 4.5% (95% CI 3.8, 5.4). Prevalence increased with age from 0.7% (95% CI 0.4, 1.6) in men 20 to 34 years old, to 16.0% (95% CI 13.0, 19.4) in men 75 years old or older (p <0.001). We found no difference in prevalence by racial/ethnic group (p = 0.38). Factors significantly associated (p <0.05) with urinary incontinence were age (per 10-year increase, OR 1.8; 95% CI 1.6, 2.0), major depression (OR 2.7; 95% CI 1.6, 4.0) and hypertension (OR 1.3; 95% CI 1.1, 1.5). CONCLUSIONS: Age and race adjusted prevalence estimates for urinary incontinence in men are consistent with other estimates using a similar definition. To our knowledge this is the first study that identifies factors associated with moderate to severe urinary incontinence in men.