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


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.


CONCLUSIONS
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.
Toglia
Marc R
MR
Urogynecology Associates of Philadelphia, Media, PA 19063, USA. togliam@verizon.net
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
D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D011812:Quinuclidines / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate