A double‐blind, randomized, placebo‐controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan

Abstract

Objective: This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration. Methods: This randomized, double-blind, placebo-controlled, two-arm, parallelgroup, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups. Results: A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (−1.29 ± 2.23 vs-0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (−0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria. Conclusion: Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.

Effect of Pharmacotherapy for Overactive Bladder on the Incidence of and Factors Related to Urinary Tract Infection: A Systematic Review and Meta-analysis

“…Finally, 33 trials with 35,939 patients (29 trials with 27,135 patients for anticholinergics vs placebo, and 9 trials with 8,804 patients for beta 3–adrenoceptor agonists vs placebo) were eligible for the analysis (Table 2). 10-42 Follow-up duration was 1-3 months. Mean patient age was 43.7-75.1 years, and the proportion of male study participants was 0%-100% (Table 2).…”

Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis

“…Twenty-nine RCTs ( 15 – 19 , 22 – 30 , 37 – 51 ) reported urgency episodes/d, including three 4-arm studies, eight 3-arm studies and 18 two-arm studies, containing a total of 14 treatment measures and a total sample size of 17,859 cases ( Figure-2 ). The results showed that FES8mg-QD was the most effective in reducing mean daily urgency incontinence episodes, followed by SOL10mg-QD, with no statistically significant difference between the two, but both showed significant improvements in efficacy compared to most other interventions.…”

“…Twenty-seven RCTs ( 14 – 19 , 22 , 24 – 26 , 29 – 31 , 35 – 38 , 40 – 44 , 46 – 48 , 53 , 54 ) reported voided volume per micturition, including three 4-arm studies, ten 3-arm studies, and fourteen two-arm studies containing 11 treatment measures with a total sample size of 9,426 cases ( Figure-2 ). Initially, subgroup regression analysis was performed due to inconsistencies.…”