Abstract
Women with urge or mixed incontinence were randomized to a daily dose of 10 mg extended-release oxybutynin chloride (qd) or tolterodine tartrate 4 mg (2 mg bid) for 12 weeks. Subjects completed 7-day voiding diaries at baseline and at 12 weeks. A total of 315 women were treated. At the end of the study, extended-release oxybutynin chloride was more effective than twice-daily tolterodine tartrate as measured by urge and total incontinence episodes (p=0.038, p=0.030, respectively). Overall, the reduction in micturition frequency between groups was not significantly different. In women aged 64 years and younger (comprising 63% of the population) extended-release oxybutynin was more effective than tolterodine for urge (p=0.005) and total incontinence (p=0.005), and for micturition frequency (0.024). Adverse events were infrequent, mostly mild, and similar between treatment groups. We concluded that daily extended-release oxybutynin chloride (10 mg) was more effective than tolterodine tartrate (2 mg bid) in treating urge and total incontinence. The incidences of dry mouth, CNS events, and other adverse events were similar for both drugs.
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This study was sponsored by ALZA Corporation, Mountain View, California.
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Editorial Comment: This manuscript compares the efficacy of extended-release oxybutynin to twice-daily tolterodine with respect to episodes of urge incontinence, all leakage episodes, and micturition frequency in women with overactive bladder. Data were obtained from 7-day voiding diaries completed by the subjects at baseline and at 12 weeks. The authors conclude that daily extended-release oxybutynin chloride (10 mg) was more effective than tolterodine tartrate (2 mg bid) in treating urge incontinence, total incontinence and urinary frequency. They found the incidence of dry mouth, CNS events and other adverse events to be similar. Although the authors attempted to blind both investigators and subjects by adding placebo for the second dose of the oxybutynin group, the fact remains that comparison was made between one group receiving a daily study medication plus a placebo for the second dose, and one group receiving a study medication twice daily. Unfortunately, this study was completed before extended-release tolterodine was available. Future studies comparing extended-release oxybutynin with extended-release tolterodine at identical dosage schedules would be of interest.
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Sand, P.K., Miklos, J., Ritter, H. et al. A comparison of extended-release oxybutynin and tolterodine for treatment of overactive bladder in women. Int Urogynecol J 15, 243–248 (2004). https://doi.org/10.1007/s00192-004-1161-9
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DOI: https://doi.org/10.1007/s00192-004-1161-9