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Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.

ABSTRACT: Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population.All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated questionnaires, which included the single-item Patient Perception of Bladder Condition (PPBC), the King's Health Questionnaire (KHQ) and the Beck Depression Inventory-II (BDI-II).The proportion of men (n=369; mean age=69.6 years) who reported that their bladder condition caused moderate, severe or many severe problems (PPBC>or=4) improved from 77.3% at baseline to 38.1-53.6% in subsequent months. Mean KHQ scores decreased significantly (p12 (associated with a diagnosis of depression) decreased from 23.9% to 17.9% (p=0.0055). Men with a history of 'prostate problems' or use of 'BPH medication' (32.2%) had KHQ domain changes that were similar (p>or=0.1016) to those of other men. Most men (76.2%) reported no treatment-related adverse events; two men (0.5%) experienced symptoms of mild urinary retention, but neither required catheterisation.Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition.

SUBMITTER: Staskin DR

PROVIDER: S-EPMC2228367 | biostudies-literature | 2008 Jan

REPOSITORIES: biostudies-literature

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Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.

Staskin D R DR Rosenberg M T MT Dahl N V NV Polishuk P V PV Zinner N R NR

International journal of clinical practice 20071115 1

<h4>Aims</h4>Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population.<h4>Methods</h4>All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated qu ...[more]

PMID: 17983434

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Project description:BackgroundQuality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3 -adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.MethodsPatients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.ResultsOf the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB-q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end-points at week 12 (P < .05 each) and were classified as responders (P < .05 each).ConclusionsIn the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.Clinical trial registrationClinicalTrials.gov identifier number NCT03492281.

Project description:Overactive bladder (OAB) is a prevalent condition characterized by lower urinary tract symptoms (LUTS). Age, education, income, marital status, sleep, and emotional problems have been associated with OAB; however, conflicting results exist. The present study was conducted to estimate the prevalence of OAB and comprehensively analyze its associated factors in a large cross-sectional, population-based study. The data of 94,554 participants aged 19-107 were analyzed from the Korean Community Health Survey (KCHS) of 2012. Data on marital status, physical activity, education level, occupation, body mass index (BMI), income level, sleep time, and stress level were retrieved for all enrolled participants. The overactive bladder symptom score (OABSS) was used to evaluate the presence and degree of OAB. Simple and multiple logistic regression analyses with complex sampling were used for the associations between various factors and the presence of OAB. Overall, OAB was present in approximately 2.9% of the participants. The prevalence of OAB increased with age and steeply increased after 60 years of age (adjusted odds ratio [AOR] for each 10 years = 1.70, 95% confidence interval [CI] = 1.61-1.80, P<0.001). The prevalence of OAB was lower in married than unmarried subjects (AOR = 0.59, 95% CI = 0.48-0.72, P<0.001). The prevalence of OAB was significantly different according to occupation Compared to manager, expert, specialist, clerk group, the prevalence of OAB was highest in unemployed group (AOR = 1.90, 95% CI = 1.55-2.32, P < 0.001). Being underweight was correlated with OAB (AOR = 1.29, 95% CI = 1.08-1.55, P = 0.018). Inadequate sleep showed a significant association with OAB (AOR = 1.13, 95% CI = 1.02-1.25 for ≤6 hours of sleep time and AOR = 1.53, 95% CI = 1.27-1.86 for ≥9 hours of sleep, P<0.001). Stress level showed a dose-dependent positive association with OAB [AOR (95% CI) = 3.91 (3.13-4.89) > 2.16 (1.88-2.48) > 1.39 (1.23-1.57) for severe stress > moderate stress > some stress, respectively, P<0.001]. A medical history of diabetes mellitus, hyperlipidemia, and/or cerebral stroke was significantly related to OAB. Approximately 2.9% of adult Korean men experienced OAB based on the OABSS. Unmarried status; occupation; being underweight; inadequate sleep; stress; and medical history of diabetes mellitus, hyperlipidemia, or cerebral stroke were significantly correlated with OAB.

Dataset Information

Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.

Publications

Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.

Similar Datasets

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