Efficacy and Safety of 10 mg Solifenacin Succinate in Patients with Overactive Bladder Syndrome: Results from a Randomized, Double-Blind, Placebo-Controlled Phase III Pivotal Trial

Introduction This multicenter, randomized, double-blind, parallel-group, Phase III, pivotal trial investigated the efficacy and safety of solifenacin succinate 10 mg, a once-daily (OD) oral antimuscarinic agent, in overactive bladder syndrome (OAB). Materials and methods A total of 634 adult patients with OAB symptoms were randomized to either solifenacin 10 mg (n = 318) or placebo (n = 316) OD over 12 weeks, to examine changes from baseline in micturition-, incontinence-, urgency- and nocturia-episodes/24 hours, measured using a 3-day diary. Results Solifenacin significantly reduced the mean number of micturition-, urgency- and incontinence-episodes/24 hours at end of treatment (P < 0.001 for all versus placebo); these improvements were observed at 4 weeks, and continued over 12 weeks. Adverse events were generally mild or moderate in severity and typically anticholinergic in nature. Conclusions Solifenacin 10 mg OD was well tolerated and effective in treating major OAB symptoms, including urinary incontinence, frequency and urgency.