Research article summary (published 30 Aug 2009):

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

Full 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

Author information

Author/s: Toglia, Marc R (MR); Serels, Scott R (SR); Laramée, Christine (C); Karram, Mickey M (MM); Nandy, Indrani M (IM); Andoh, Masakazu (M); Seifeldin, Raafat (R); Forero-Schwanhaeuser, Sergio (S);

Affiliation: Urogynecology Associates of Philadelphia, Media, PA 19063, USA. togliam(-atsign-)verizon.net

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Postgraduate medicine (Postgrad Med), published in United States. (Language: eng)

Reference: 2009-Sep; vol 121 (issue 5) : pp 151-8

Dates: Created 2009/10/12; Completed 2009/11/04;

PMID: 19820284, status: MEDLINE (last retrieval date: 11/4/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Aged Double-Blind Method Female Humans Male Middle Aged

Middle Aged Muscarinic Antagonists - therapeutic use Quinuclidines - therapeutic use Tetrahydroisoquinolines - therapeutic use Treatment Outcome Urinary Bladder, Overactive - drug therapy

Associated Chemicals: Muscarinic Antagonists (0) ; Quinuclidines (0) ; Tetrahydroisoquinolines (0) ; quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate (0)

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