Objective: Evaluate patient and physician satisfaction with a novel formulation of a once-daily controlled-release (CR) oxybutynin (Uromax*) 15-mg tablet as both the initial and maintenance dose in elderly and non-elderly patients with overactive bladder (OAB).
Methods: Patients not on anticholinergic treatment for OAB and experiencing urinary incontinence (≥1 episode/week) and micturition frequency (≥8 episodes/day) or urgency (≥1 episode/week) were enrolled in this 4-week, open-label study. Satisfaction, efficacy, mental status and adverse events were evaluated by urologists, gynecologists, urogynecologists and family practitioners. The analyses compared the outcomes in patients <65 and ≥65 years.
Clinical trial registration: ISRCTN 19242032.
Results: A total of 240 patients enrolled; 111 (46%) were ≥65 years of age. Completion rate was 76.0% (<65) and 62.2% (≥65) (p = 0.0204). Medication was rated as tolerable by 75.2% of patients <65 and 58.6% of patients ≥65 (p = 0.0099). Based on overall satisfaction scores 64.2% (patient scores) and 57.1% (physician scores) of patients were considered 'successfully treated' (p = 0.0001 & p = 0.0451). There was a significant reduction in incontinence (64.3%; p = 0.0001), nocturia (38.6%; p = 0.0001) and night-time incontinence (39.7%; p = 0.0436) with no difference between age groups. Total continence was achieved by 29.8% and 47.5% of patients <65 and ≥65, respectively (p = 0.0077). No patients clinically experienced confusion or delirium and only six patients ≥65 had a decrease in MMSE score of ≥3 units, which was not statistically different from patients <65 (p = 0.3112). Dry mouth was the most common adverse event reported by 24.8% of patients <65 and 36.0% of patients ≥65 (p = 0.0584). Limitations of the study include a fixed dosing, no control group and 4-week trial.
Conclusion: Patients and physicians were satisfied with CR oxybutynin 15 mg once-daily. Patients tolerated the CR oxybutynin 15 mg as both the initial and maintenance dose and provided significant reductions in incontinence, nocturia and night-time incontinence without a significant change in cognitive status. Total continence rates were significantly superior in patients ≥65 and there was no difference in dry mouth, cognitive status or efficacy in patients <65 and ≥65.