Preliminary evaluation of a new controlled-release oxybutynin in urinary incontinence

OBJECTIVE: To conduct a preliminary evaluation of a new oral formulation of controlled-release (CR) oxybutynin tablet taken once-daily in patients with urinary urge incontinence. RESEARCH DESIGN AND METHODS: A single-centre, open-label, 8-week study was conducted. Patients with urodynamically-confirmed detrusor instability, micturition frequency (>/= 8 voids/day) and/or urinary incontinence (>/= 2 incontinence periods/day) were enrolled. The study duration was 8 weeks: patients received IR oxybutynin (2.5-5 mg bid) for 2 weeks, followed by a 2-week washout/baseline period to avoid carryover effects, and oral CR oxybutynin (15 mg OD) for 4 weeks. Daily void frequency, fluid intake, urinary incontinence episodes, and spontaneously reported adverse events were recorded in a daily diary for five consecutive days in each treatment period. RESULTS: Of 12 enrolled patients, 9 patients efficacy; all patients were evaluable for safety. completed the study and were evaluable for Compared to baseline/washout, CR oxybutynin reduced UI episodes/day by 45% (p = 0.13) and micturitions/day by 15% (p = 0.07). Treatment with IR oxybutynin (mean dose: 6.7 +/- 2.5 mg/day) reduced UI episodes/day from baseline by 7% (p = 0.58) and voids/day by 6% (p = 0.29). Fluid intake remained consistent at approximately 2 litres/day during all study periods. The most common adverse event was dry mouth. CONCLUSIONS: Based on the reductions in daily frequency of incontinence and micturition following 4-weeks treatment, CR oxybutynin (15 mg OD) was at least as effective as the patients' previous dose of IR oxybutynin (mean dose: 6.7 +/- 2.5 mg/day). These improvements were achieved without restriction of fluid intake. Initial 15 mg doses of CR oxybutynin appear to be well tolerated.