Randomized, open‐label, tolterodine‐controlled, comparative study of the novel antimuscarinic agent imidafenacin in patients with overactive bladder

BACKGROUND: The role of the selective antimuscarinic imidafenacin in Caucasian patients with overactive bladder (OAB) has not been previously assessed. OBJECTIVE: To evaluate the safety and efficacy of imidafenacin 0.2 mg vs tolterodine 4 mg per day in patients with OAB. DESIGN SETTING AND PARTICIPANTS: This study was a randomized, open-label, tolterodine-controlled, comparative multicenter trial of 300 randomized patients with OAB symptoms for 12 weeks with full analysis of 289 patients. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Based on 5-day bladder diaries, the primary efficacy endpoint was the change in the mean number of micturitions per day. The secondary endpoints were the change in the mean incontinence episodes, voiding frequency, the OAB Awareness Tool score, and the European Quality of Life Questionnaire (EQ-5D) score. The superiority of tolterodine over imidafenacin in the mean number of micturitions/24 hours was the null hypothesis. RESULTS AND LIMITATION: The median age was 46.6 years, and 82% of patients were female. After treatment, the change in the mean number of incontinence episodes was -2.1 ± 2.2 in the imidafenacin group and -1.9 ± 1.8 in the tolterodine group (P = .001). The change in the mean number of daytime incontinence episodes was -1.7 ± 1.7 and -1.5 ± 1.4 ( P = .01). The OAB Awareness Tool score decreased by 14.2 ± 8.5 and 14.5 ± 8.0, respectively ( P = 0.5). Most adverse events were mild and resolved without treatment. CONCLUSIONS: The clinical efficacy and safety of imidafenacin are not inferior to those of tolterodine for the treatment of Caucasian patients with OAB. PATIENT SUMMARY: Imidafenacin is as effective as tolterodine for the treatment of OAB.