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| |  Oxybutynin Chloride Topical Gel Improves Urinary Incontinence in Women With Overactive Bladder: Presented at AUA By Bruce Sylvester CHICAGO -- April 30, 2009 -- Oxybutynin chloride topical gel treatment significantly improves the incidence of daily episodes of urinary incontinence for women with overactive bladder, according to research reported here at the 2009 American Urological Association (AUA) Annual Meeting. "Significantly more women achieved complete urinary continence with oxybutynin gel than with placebo -- with 'complete continence' defined as no urinary incontinent episodes recorded in the 3-day urinary diary at any time after the study began," noted lead investigator Roger Dmochowski, MD, Vanderbilt University School of Medicine, Nashville, Tennessee, who presented the study results here on April 28. The original phase 3 study evaluated oxybutynin chloride topical gel for efficacy and safety in the treatment of overactive bladder. The randomised, parallel-group, double-blind, placebo-controlled study enrolled men and women 18 years of age or older who had overactive bladder and urge urinary incontinence. In the current subanalysis of women only, Dr. Dmochowski's team reported findings for 704 female subjects (352 in the actively treated group and 352 in the placebo group). The mean age of the women was 59 years, and 87% were white. Subjects were randomised 1:1 to treatment for 12 weeks with 1 g/day of transdermal oxybutynin gel or placebo, applied once daily to rotating sites on the abdomen, upper arm/shoulder, and thigh. The primary endpoint, measured at week 12, was the mean number of daily episodes of urinary incontinence recorded by subjects in a 3-day bladder diary. The researchers used standard statistical analyses to compare efficacy results for active treatment to placebo. They also monitored adverse events throughout the study. The final analysis demonstrated that 27% (95/352) of the women treated with oxybutynin chloride topical gel achieved a significantly higher rate of complete urinary continence compared to 15.6% (55/352) of the women treated with placebo (P < .0001). Dry mouth was the most frequent treatment-related anticholinergic adverse event, appearing more often among actively treated subjects (7.4%, 26/352) than with placebo (2.8%, 10/352). No subjects withdrew due to dry mouth. Pruritus was the most frequently reported application-site reaction, appearing in 2.3% (8/352) of actively treated women and 0.9% of (3/352) women treated with placebo. Two actively treated women and 1 woman treated with placebo withdrew from the study, primarily due to application-site reactions. The investigators reported no serious treatment-related adverse events. Oxybutynin chloride gel was approved by the US Food and Drug Administration in January of 2009 for the treatment of overactive bladder in men and women. Funding for this study was provided by Watson Pharmaceuticals.
[Presentation title: Efficacy and Safety of Oxybutynin Chloride Topical Gel in Women With Overactive Bladder: A Randomized, Placebo-Controlled, Double-Blind Study. Abstract 1636]
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