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

• Published in: American journal of obstetrics and gynecology 2012-02, Vol.206 (2), p.168.e1-168.e6
• Main Authors: Sand, Peter K., MD, Davila, G. Willy, MD, Lucente, Vincent R., MD, MBA, Thomas, Heather, PhD, Caramelli, Kim E., MS, Hoel, Gary, PhD
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Aged; Biological and medical sciences; Double-Blind Method; efficacy; Female; Gels; Gynecology. Andrology. Obstetrics; Humans; Mandelic Acids - administration & dosage; Mandelic Acids - adverse effects; Mandelic Acids - therapeutic use; Medical sciences; Middle Aged; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Muscarinic Antagonists - therapeutic use; Nephrology. Urinary tract diseases; Obstetrics and Gynecology; overactive bladder; oxybutynin chloride topical gel; Quality of Life; safety; Treatment Outcome; Urinary Bladder, Overactive - drug therapy; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; women
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2011.08.005

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.