Osamu Yamaguchi1, Eiji Uchida2, Naruhito Higo3, Hidenao Minami3, Shigeo Kobayashi3, Hiroyuki Sato3. 1. Division of Bioengineering and Lower Urinary Tract Dysfunction Research, School of Engineering, Nihon University, Koriyama, Japan. yamaosa@ee.ce.nihon-u.ac.jp. 2. Office for Promoting Medical Research, Showa University, Tokyo, Japan. 3. Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.
Abstract
OBJECTIVE: To evaluate the efficacy, safety, and optimum dose of once-daily oxybutynin patch for overactive bladder. METHODS: A randomized double-blind trial was conducted in patients with overactive bladder symptoms for ≥24 weeks, who received anoxybutynin patch (73.5 or 105 mg) or placebo once daily for 8 weeks. The primary endpoint was the change in the daily frequency of micturition from baseline to the end of study. RESULTS: A total of 579 patients were randomized to the placebo group (n = 164), 73.5 mg oxybutynin patch group (n = 166), and 105 mg oxybutynin patch group (n = 165). The frequency of micturition (mean ± standard deviation) decreased by 1.19 ± 1.80 in the placebo group, 1.87 ± 1.93 in the 73.5 mg group, and 1.80 ± 1.76 in the 105 mg group. Compared with the placebo group, micturition decreased significantly in the 73.5 mg and 105 mg groups (t-test: P = 0.0025 and 0.0039, respectively), while the decrease was similar in both oxybutynin groups. The oxybutynin groups showed significant improvement of urgency, urge incontinence, incontinence, nocturia, mean voided volume, and five or six domains of the King's Health Questionnaire. Dry mouth was noted in 12.1% of the 73.5 mg group and 13.3% of the 105 mg group. Constipation was comparable between the oxybutynin groups and the placebo group. Application site reactions were less frequent in the 73.5 mg group than the 105 mg group. CONCLUSION: The efficacy of oxybutynin patch was confirmed, and the optimum dose for Japanese patients with overactive bladder was 73.5 mg.
RCT Entities:
OBJECTIVE: To evaluate the efficacy, safety, and optimum dose of once-daily oxybutynin patch for overactive bladder. METHODS: A randomized double-blind trial was conducted in patients with overactive bladder symptoms for ≥24 weeks, who received an oxybutynin patch (73.5 or 105 mg) or placebo once daily for 8 weeks. The primary endpoint was the change in the daily frequency of micturition from baseline to the end of study. RESULTS: A total of 579 patients were randomized to the placebo group (n = 164), 73.5 mg oxybutynin patch group (n = 166), and 105 mg oxybutynin patch group (n = 165). The frequency of micturition (mean ± standard deviation) decreased by 1.19 ± 1.80 in the placebo group, 1.87 ± 1.93 in the 73.5 mg group, and 1.80 ± 1.76 in the 105 mg group. Compared with the placebo group, micturition decreased significantly in the 73.5 mg and 105 mg groups (t-test: P = 0.0025 and 0.0039, respectively), while the decrease was similar in both oxybutynin groups. The oxybutynin groups showed significant improvement of urgency, urge incontinence, incontinence, nocturia, mean voided volume, and five or six domains of the King's Health Questionnaire. Dry mouth was noted in 12.1% of the 73.5 mg group and 13.3% of the 105 mg group. Constipation was comparable between the oxybutynin groups and the placebo group. Application site reactions were less frequent in the 73.5 mg group than the 105 mg group. CONCLUSION: The efficacy of oxybutynin patch was confirmed, and the optimum dose for Japanese patients with overactive bladder was 73.5 mg.