Multicenter, Randomized, Double-Blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 (Combination of Tolterodine and Pilocarpine) in Patients with Overactive Bladder Including an Open-Label, Extension Study.

Purpose:We evaluated the efficacy and safety of THVD-201, a combination of tolterodine 2 mg and pilocarpine 9 mg, vs tolterodine monotherapy in patients with overactive bladder.Materials and Methods:We enrolled patients with overactive bladder symptoms in a multicenter, randomized, double-blind, parallel, active control study. Patients were randomized to THVD-201 or tolterodine 2 mg twice daily for 12 weeks. After the double-blind period finished all patients were started on THVD-201 for 12 weeks. Study co-primary end points were the change from baseline in the mean number of daily micturitions and cumulative incidence of dry mouth at the end of 12 weeks. Secondary end points were other overactive bladder symptoms, the total xerostomia inventory score and results of a visual analogue scale for dry mouth at the end of 12 and 24 weeks.Results:The mean change in the number of daily micturitions from baseline to 12 weeks was –1.49 and –1.74 in the THVD-201 and tolterodine monotherapy groups, respectively. The...