Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial

Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.

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.

Trial registration: ClinicalTrials.gov NCT00454896.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use*
  • Quinuclidines / therapeutic use*
  • Solifenacin Succinate
  • Tetrahydroisoquinolines / therapeutic use*
  • Treatment Outcome
  • Urinary Bladder, Overactive / drug therapy*

Substances

  • Muscarinic Antagonists
  • Quinuclidines
  • Tetrahydroisoquinolines
  • Solifenacin Succinate

Associated data

  • ClinicalTrials.gov/NCT00454896