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| |  Oxybutynin Chloride Topical Gel Improves Quality of Life and Is Well Tolerated by Women With Overactive Bladder: Presented at AUGS By Charlotte Libov HOLLYWOOD, Fla -- September 30, 2009 -- Treatment with oxybutynin chloride topical gel (OTG) results in significant improvement of quality of life (QOL) in women with overactive bladder (OAB) and is well tolerated, according to a study here at the 30th Annual Scientific Meeting of the American Urogynecologic Society (AUGS). Peter Sand, MD, Evanston Continence Center, Northwestern University, Evanston, Illinois, and colleagues studied the effects of OTG on people with OAB in this subanalysis of a previously published phase 3 trial.(1) Results of the study were presented on September 26. The analysis was undertaken to determine whether OTG is effective in improving QOL compared with traditional patch applications, Dr. Sand said. The analysis involved 704 women aged 18 years and older (mean 59 years) and diagnosed with OAB syndrome and urinary incontinence (UI) from multiple centres. The patients were randomised to treatment with OTG 1 g or matching placebo applied once daily to rotating skin sites for 12 weeks. The number of daily UI episodes was the primary endpoint. Secondary endpoints were urinary frequency, void volume, and episodes of nocturia. The proportion of patients who achieved complete continence was also determined. The Incontinence Impact Questionnaire (IIQ) and the King’s Health Questionnaire (KHQ) were used to assess QOL. Differences in efficacy and QOL between groups were compared via analysis of covariance. Starting with week 4 of treatment, patients in the OTG group experienced significantly reduced UI episodes compared with placebo. By the end of the study, daily UI episodes were reduced by 3.0 and 2.5 in the OTG and placebo groups, respectively (P <€.0001). Significantly greater improvement was also seen in daily urinary frequency (-2.8; P = .0013) and voided volume (+22.7 mL; P = .0006) with OTG than with placebo, and complete continence was achieved by a greater proportion of OTG-treated patients (27.0 vs 15.6%; P = .0002). QOL was improved significantly more in the OTG group than the placebo group, as measured by IIQ (total score -73.3 vs -47.8; P = .0001) and KHQ. The most commonly reported adverse events for the OTG-treated patients were dry mouth (7.4% vs 2.8%) and application-site pruritus (2.3% vs 0.9%). The researchers concluded that OTG significantly improved disease symptoms and QOL and was generally well tolerated. According to Dr. Sand, the study showed that the new OTG holds promise as a treatment option for women with OAB. “An estimated 14% to 17% of women experience adverse skin reaction with the transdermal patch, but the gel dramatically reduced that,” he said. The study was funded by Watson Pharmaceuticals. 1. Staskin DR et al. J Urol. 2009;181:1764-1772. [Presentation title: Efficacy and Quality-of-Life Effects of Oxybutynin Chloride Topical Gel in Women With Overactive Bladder. Paper 50]
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