Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial

Autor: T. S. Marshall, Sergio Forero-Schwanhaeuser, Michael D. Vardy, J. D. Wegenke, W. He, H D Mitcheson, T.-A. Samuels
Rok vydání: 2009
Předmět:
Zdroj: International Journal of Clinical Practice. 63:1702-1714
ISSN: 1742-1241
1368-5031
DOI: 10.1111/j.1742-1241.2009.02209.x
Popis: Summary Aim: The aim of this study was to evaluate the efficacy of solifenacin on symptom bother using the Overactive Bladder Questionnaire (OAB-q). Methods: In VIBRANT, a double-blind, US-based trial, patients with OAB for ≥ 3 months received flexibly dosed solifenacin or placebo for 12 weeks. At baseline and 4-week intervals, patients completed the OAB-q [symptom bother and health-related quality of life (HRQL) scales] and 3-day bladder diaries; other patient-reported outcome measures were also assessed at baseline and week 12. The primary efficacy end-point was the change from baseline to end of treatment (EOT) on the OAB-q Symptom Bother scale. Adverse events (AEs) were monitored. Results: At EOT, solifenacin (n = 377) vs. placebo (n = 374) significantly improved mean symptom bother (−29.9 vs. −20.4, p
Databáze: OpenAIRE