A Double-Blind Double-Dummy Randomized Controlled Multicenter Clinical Trial on Toterodine Versus Oxybutynin in the Treatment of Overactive Bladder

OBJECTIVE: To evaluate the efficacy and tolerability of tolterodine in patients with an overactive bladder. METHODS: A double-blind double-dummy randomized controlled multicenter clinical trial was designed. 237 patients with bladder overactivity were enrolled, Patients received either tolterodine (2mg twice daily) or oxybutynin (5mg twice daily). RESULTS: After 6 weeks' treatment, the mean decrease of frequency of micturition, the mean decrease of incontinence episodes among those with incontinence and the volume increase of every micturition were statistically equivalent in those receiving tolterodine (n=109) and oxybutynin (n=108). In the tolterodine group, the total incidence of adverse event was 48.2% and the incidence of dry mouth, the most common adverse, was 32.5%. While in the oxybutynin group, the incidences were 65.0% and 55.3%, respectively. The incidences of adverse events and dryness were significantly lower in those on tolterodine than in those on oxybutynin. CONCLUSIONS: Tolterodine 2mg twice daily had the equivalent efficacy on patients with overactive bladder compared to oxybutynin 5mg twice daily, and the adverse-effection of tolterodine were lower than oxybutynin.