DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

A double-blind randomized dose-response study comparing daily doses of 5, 10 and 15 mg controlled-release oxybutynin: balancing efficacy with severity of dry mouth.

Author(s): Corcos J, Casey R, Patrick A, Andreou C, Miceli PC, Reiz JL, Harsanyi Z, Darke AC, Uromax Study Group

Affiliation(s): Jewish General Hospital, Montreal, QC, Canada.

Publication date & source: 2006-03, BJU Int., 97(3):520-7.

Publication type: Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To assess the efficacy, incidence of dry mouth and overall satisfaction with initial doses of 5, 10 and 15 mg of a new, once-daily, controlled-release (CR) form of oxybutynin for treating urge urinary incontinence (UUI). PATIENTS AND METHODS: Patients who reported urinary incontinence (UI) (one or more episodes/diary) and voiding frequency (eight or more voids/day) or urgency (one or more episodes/diary) during a 2-week baseline were randomized to once-daily 5, 10 or 15 mg CR oxybutynin for 4 weeks. Daily episodes of UI, voids, urgency, adverse events, dry mouth and satisfaction were recorded in a 3-day diary at baseline and after 4 weeks of treatment. In all, 237 patients were randomized and evaluated. RESULTS: Episodes of UI, voids and urgency were significantly reduced over the study period at all doses. Daily UI episodes were significantly lower with 15 mg/day than 5 and 10 mg/day. Dry mouth symptoms were similar in the 10 and 15 mg/day groups, and higher than in the 5 mg/day group. However, significantly greater overall satisfaction was reported with 15 than 5 mg/day. CONCLUSIONS: There were significant dose-response relationships with CR oxybutynin for both UI episodes and dry mouth. The greatest satisfaction was with 15 mg/day, and the severity of dry mouth was comparable at 10 mg/day, indicating that greater efficacy at the higher dose did not compromise tolerability.

Page last updated: 2006-11-05

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017