Solifenacin for Overactive Bladder: Patient-Reported Outcomes from a Large Placebo-Controlled Trial

• Published in: Postgraduate medicine 2009-09, Vol.121 (5), p.151-158
• Main Authors: Toglia, Marc R., Serels, Scott R., Laramee, Christine, Karram, Mickey M., Nandy, Indrani M., Andoh, Masakazu, Seifeldin, Raafat, Sergio, Forero-Schwanhaeuser
• Format: Article
• Language: English
• Subjects: Aged; Double-Blind Method; Female; Humans; Male; Middle Aged; Muscarinic Antagonists - therapeutic use; overactive bladder; patient-reported outcomes; Quinuclidines - therapeutic use; solifenacin; Solifenacin Succinate; Tetrahydroisoquinolines - therapeutic use; Treatment Outcome; Urinary Bladder, Overactive - drug therapy; urinary urgency
• ISSN: 0032-5481; 1941-9260
• DOI: 10.3810/pgm.2009.09.2062

Objective: Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported. Materials and Methods: In this 12-week multicenter trial, 739 patients (aged ⩾ 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo. Prespecified secondary PRO measures included the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). Appropriate statistical tests compared treatment-group differences in continuous and categorical data. Results: In the full analysis set, patients who received solifenacin (n = 357) versus placebo (n = 350) showed significant improvements on the IUSS and UPS; treatment-group differences were 0.4 (P < 0.0001) and 0.2 (P = 0.0018), respectively. On the PPBC, significantly more patients taking solifenacin (66%) than placebo (48%) perceived fewer bladder-related problems (P < 0.0001) by week 12. On the OAB-q, solifenacin was superior to placebo for the Symptom Bother and total HRQL scales and for 3 of the 4 HRQL domains at study end (P < 0.01). Overall, these findings were consistent with those reported previously for bladder-diary-documented urgency and other OAB symptoms. Conclusion: Flexibly dosed, once-daily solifenacin was associated with statistically significant and clinically meaningful improvements in urgency and other symptom-specific bother and HRQL compared with placebo.