Efficacy and safety of skin-adhesive low-level light therapy for overactive bladder: a Phase III study.

INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) is a common condition that remains challenging to treat. We hypothesized that skin-adhesive low-level light therapy (LLLT) would be an effective treatment for OAB caused by bladder muscle contraction. Accordingly, we aimed to evaluate the efficacy and safety of an LLLT device for the treatment of OAB. METHODS: This prospective, randomized, double-blind, placebo-controlled, multicenter trial included patients with a clinical diagnosis of OAB who were treated at either of two university hospitals. Patients were instructed to apply an LLLT device (Color DNA-WSF) or a sham device at home three times daily for 12 weeks. The primary outcome was the change in the mean daily number of urge urinary incontinence (UUI) episodes between baseline and 12 weeks. The secondary outcomes were the mean changes in incontinence, voiding, and nocturia episodes from baseline and the likelihood of achieving a > 50% reduction in UUI and incontinence episodes after 12 weeks. All patients completed the Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), and Impact Urinary Incontinence-7 (IIQ-7) questionnaires. Safety parameters included treatment-emergent adverse events. RESULTS: Compared with those in the sham group, the numbers of UUI and urinary incontinence episodes in the LLLT group were significantly decreased at week 12 (UUI, (-1.0 ± 1.7 vs. -0.4 ± 2.5, P = 0.003; urinary incontinence, -1.1 ± 1.9 vs. -0.5 ± 2.9, P=0.002). Furthermore, the OABSS, UDI-6, and IIQ-7 scores at week 12 tended to be better in the LLLT group than in the sham group. The incidence of device-related treatment-emergent adverse events was similar between groups. CONCLUSIONS: LLLT may be clinically useful and safe for the treatment of OAB.

Vitamin D intake and the 10-year risk of urgency urinary incontinence in women.

Evidence indicates that higher serum 25-hydroxy vitamin D levels may be associated with decreased prevalence of urgency urinary incontinence (UI), but the impact of vitamin D consumption on development of urgency and mixed UI is unclear. The objective was to assess whether greater vitamin D intake was associated with decreased risk of incident urgency and mixed UI over 10 years using 2 large prospective cohorts of middle-aged and older women. We analyzed 38,101 women from the Nurses' Health Study I (NHS I) and 35,190 women from NHS II who were free of UI at baseline. We followed incident UI, defined as new UI occurring at least monthly, separately by subtype (urgency, mixed, stress UI), from 2002-2012. We categorized vitamin D intake from supplements and diet. We estimated relative risk for developing UI according to vitamin D intake using Cox-proportional hazard models with adjustment for covariates. Median vitamin D intake was 580IU in the older women in NHS I (age range 56-71 at baseline) and 487IU in middle-aged women in NHS II (age range 40-57). Among women taking ≥1000IU of vitamin D, median intake in the older women was 1252IU and 1202IU in the middle-aged women. Among the older women, we found no relation of vitamin D intake to risk of developing UI, across all UI subtypes. In multivariable-adjusted analysis for middle-aged women, the relative risk of developing mixed UI among women taking >1000IU was 0.79 (0.63, 0.99) and for urgency UI was 0.88 (0.71, 1.07), versus <200IU. Risks of developing stress UI were not related to vitamin D intake categories. Overall, we did not find a relationship between vitamin D intake and UI incidence in middle-aged and older women; however, the reported intake was moderate.

Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence.

PURPOSE: We sought to identify clinical and demographic characteristics associated with treatment response and satisfaction in women undergoing onabotulinumtoxinA and sacral neuromodulation therapies. MATERIALS AND METHODS: We analyzed data from the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial. Baseline participant characteristics and clinical variables were associated with 2 definitions of treatment response, including 1) a reduction in mean daily urgency incontinence episodes during 6 months and 2) a 50% or greater decrease in urgency incontinence episodes across 6 months. The OAB-S (Overactive Bladder-Satisfaction) questionnaire was used to assess satisfaction. RESULTS: A greater reduction in mean daily urgency incontinence episodes was associated with higher HUI-3 (Health Utility Index-3) scores in the onabotulinumtoxinA group and higher baseline incontinence episodes (each p <0.001) in the 2 groups. Increased age was associated with a lesser decrease in incontinence episodes in the 2 groups (p <0.001). Increasing body mass index (adjusted OR 0.82/5 points, 95% CI 0.70-0.96) was associated with reduced achievement of a 50% or greater decrease in incontinence episodes after each treatment. Greater age (adjusted OR 0.44/10 years, 95% CI 0.30-0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71-0.99) were associated with reduced achievement of a 50% or greater decrease in urgency incontinence episodes in the onabotulinumtoxinA group only (p <0.001 and 0.041, respectively). In the onabotulinumtoxinA group increased satisfaction was noted with higher HUI-3 score (p = 0.002) but there was less satisfaction with higher age (p = 0.001). CONCLUSIONS: Older women with multiple comorbidities, and decreased functional and health related quality of life had decreased treatment response and satisfaction with onabotulinumtoxinA compared to sacral neuromodulation for refractory urgency incontinence.

Bridging the gap: determinants of undiagnosed or untreated urinary incontinence in women.

BACKGROUND: More than a third of middle-aged or older women suffer from urinary incontinence, but less than half undergo evaluation or treatment for this burdensome condition. With national organizations now including an assessment of incontinence as a quality performance measure, providers and health care organizations have a growing incentive to identify and engage these women who are undiagnosed and untreated. OBJECTIVE: We sought to identify clinical and sociodemographic determinants of patient-provider discussion and treatment of incontinence among ethnically diverse, community-dwelling women. STUDY DESIGN: We conducted an observational cohort study from 2003 through 2012 of 969 women aged 40 years and older enrolled in a Northern California integrated health care delivery system who reported at least weekly incontinence. Clinical severity, type, treatment, and discussion of incontinence were assessed by structured questionnaires. Multivariable regression evaluated predictors of discussion and treatment. RESULTS: Mean age of the 969 participants was 59.9 (±9.7) years, and 55% were racial/ethnic minorities (171 black, 233 Latina, 133 Asian or Native American). Fifty-five percent reported discussing their incontinence with a health care provider, 36% within 1 year of symptom onset, and with only 3% indicating that their provider initiated the discussion. More than half (52%) reported being at least moderately bothered by their incontinence. Of these women, 324 (65%) discussed their incontinence with a clinician, with 200 (40%) doing so within 1 year of symptom onset. In a multivariable analysis, women were less likely to have discussed their incontinence if they had a household income < $30,000/y vs ≥ $120,000/y (adjusted odds ratio [AOR], 0.49, 95% confidence interval [CI], 0.28-0.86) or were diabetic (AOR, 0.71, 95% CI, 0.51-0.99). They were more likely to have discussed incontinence if they had clinically severe incontinence (AOR, 3.09, 95% CI, 1.89-5.07), depression (AOR, 1.71, 95% CI, 1.20-2.44), pelvic organ prolapse (AOR, 1.98, 95% CI, 1.13-3.46), or arthritis (AOR, 1.44, 95% CI, 1.06-1.95). Among the subset of women reporting at least moderate subjective bother from incontinence, black race (AOR, 0.45, 95% CI, 0.25-0.81, vs white race) and income < $30,000/y (AOR, 0.37, 95% CI, 0.17-0.81, vs ≥ $120,000/y) were associated with a reduced likelihood of discussing incontinence. Those with clinically severe incontinence (AOR, 2.93, 95% CI, 1.53-5.61, vs low to moderate incontinence by the Sandvik scale) were more likely to discuss it with a clinician. CONCLUSION: Even in an integrated health care system, lower income was associated with decreased rates of patient-provider discussion of incontinence among women with at least weekly incontinence. Despite being at increased risk of incontinence, diabetic women were also less likely to have discussed incontinence or received care. Findings provide support for systematic screening of women to overcome barriers to evaluation and treatment.

Determining outcomes, adverse events, and predictors of success after sacral neuromodulation for lower urinary disorders in women.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to determine the predictors of successful treatment of lower urinary tract disorders with sacral nerve stimulation (SNS) and the rate of adverse events and reoperations. METHODS: A retrospective case series of patients who underwent SNS at a single institution was analyzed. RESULTS: Seventy-six patients underwent stage I trial of SNS. Fifty-eight (76%) patients experienced improvement and underwent placement of an implantable pulse generator with a mean follow-up of 23.7 months (SD ± 22.3). Surgical revisions occurred in 14/58 (24%) patients and 15/58 (26%) patients had the device explanted after a mean of 2.8 years (SD ± 1.7). Patients with greater than ten incontinence episodes per day were more likely to have a successful stage I trial compared to those with less than five (OR = 10.3; 95% CI 2.1 to 50.60). CONCLUSIONS: Although SNS is a safe and effective therapy for lower urinary tract disorders, it is associated with a high reoperation rate.

Urgency-free time interval as primary endpoint for evaluating the outcome of a randomized OAB treatment.

INTRODUCTION AND HYPOTHESIS: This study was conducted to determine whether urgency-free interval (UFI) was effective to evaluate the outcome of overactive bladder (OAB) and the correlation of changes between this parameter and urgency episodes. METHODS: A randomized placebo-controlled trial was conducted involving 73 women with OAB. The interventions for a 12-week period included a vaginal electric stimulation and oxybutynin (2.5 mg) or placebo three times per day. Identical preintervention and postintervention assessments included the measurement of UFI and warning time (WT). The King's Health Questionnaire, Spearman's correlation coefficient (SCC), Kruskal-Wallis, Mann-Whitney U, and Wilcoxon-signed rank tests were used for analysis. RESULTS: A positive and significant correlation between the improvements of WT and UFI was noted in the oxybutynin group (p = 0.009). In all groups, none of the SCC revealed significant correlation between the improvement of UFI and urgency episodes (all p >or= 0.145). CONCLUSIONS: The efficacy of UFI in evaluating treatment outcome of OAB was comparable with that of WT in selected modality.