Study context: Two double-blind, placebo-controlled, randomised, 24-week phase 3 clinical studies were conducted in 1105 patients with overactive bladder, with symptoms of urge urinary incontinence, urgency and frequency, whose symptoms had not been adequately managed with at least one anticholinergic therapy. To evaluate the impact of efficacy, safety and health-related quality of life of BOTOX® in patients with OAB with UI. Patients were randomised to receive either 100 U of BOTOX® (n=557) or placebo (n=548). The co-primary end points were the mean reduction in UI episodes per day and the proportion of patients reporting a positive response on the TBS at week 12. Secondary end points were the change from baseline in daily frequency of micturition episodes, urgency episodes and health related quality of life. Mean baseline for daily UI episodes: BOTOX® 100 U 5.49/day, placebo 5.39/day. Mean baseline for daily urgency episodes: BOTOX® 100mU 8.82/day, placebo 8.31/day.5
†P<0.001 vs placebo.
‡Dry patients over a 3-day diary.