| Title | Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. | | Author(s) | Toglia MR, Serels SR, Laramée C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S | | Institution | Urogynecology Associates of Philadelphia, Media, PA 19063, USA. togliam@verizon.net | | Source | Postgrad Med 2009 Sep; 121(5):151-8. | | MeSH | Aged
Double-Blind Method
Female
Humans
Male
Middle Aged
Muscarinic Antagonists
Quinuclidines
Tetrahydroisoquinolines
Treatment Outcome
Urinary Bladder, Overactive
| | Abstract | 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 >or= 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 <or= 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. | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 19820284 |
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