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Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome

2011; Elsevier BV; Volume: 206; Issue: 2 Linguagem: Inglês

10.1016/j.ajog.2011.08.005

1097-6868

Peter K. Sand, G. Willy Davila, Vincent Lucente, Heather Thomas, Kim E. Caramelli, Gary Hoel,

Urinary Tract Infections Management

Objective This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB). Study Design Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes. Treatments were compared with the use of analysis of covariance. Results OTG significantly reduced the number (mean ± standard deviation) of daily incontinence episodes (OTG, −3.0 ± 2.8 episodes; placebo, −2.5 ± 3.0 episodes; P < .0001), reduced urinary frequency (P = .0013), increased voided volume (P = .0006), and improved select health-related quality-of-life domains (P ≤ .0161) vs placebo. Dry mouth was the only drug-related adverse event significantly more common with OTG (7.4%) than with placebo (2.8%; P = .0062). Conclusion OTG was well tolerated and provided significant improvement in urinary symptoms and health-related quality of life in women with OAB. This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB). Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes. Treatments were compared with the use of analysis of covariance. OTG significantly reduced the number (mean ± standard deviation) of daily incontinence episodes (OTG, −3.0 ± 2.8 episodes; placebo, −2.5 ± 3.0 episodes; P < .0001), reduced urinary frequency (P = .0013), increased voided volume (P = .0006), and improved select health-related quality-of-life domains (P ≤ .0161) vs placebo. Dry mouth was the only drug-related adverse event significantly more common with OTG (7.4%) than with placebo (2.8%; P = .0062). OTG was well tolerated and provided significant improvement in urinary symptoms and health-related quality of life in women with OAB.