Once-daily oxybutynin patch improves nocturia and sleep quality in Japanese patients with overactive bladder: Post-hoc analysis of a phaseIII randomized clinical trial
Once-daily oxybutynin patch improves nocturia and sleep quality in Japanese patients with overactive bladder: Post-hoc analysis of a phaseIII randomized clinical trial
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每日一次奥昔布宁贴剂可改善日本膀胱过度活动症患者的夜尿和睡眠质量：一项 III 期随机临床试验的事后分析
DOI：
10.1111/iju.12755
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发表时间：
2015
影响因子：
2.6
通讯作者：
Masegi Y.
中科院分区：
文献类型：
--
作者：
Yokoyama O;Yamaguchi A;Yoshida M;Yamanishi T;Ishizuka O;Seki N;Takahashi S;Yamaguchi O;Higo N;Minami H;Masegi Y.
ObjectivesTo investigate efficacy of a once‐ day oxybutynin patch for adults，and its impact on sleep quality in patients with overactive bladder.MethodsWe carried post-hoc analysis of a phase III，randomized，double‐blind，comparative study in which an oxybutynin patch was administered once daily for 12 weeks to Japanese patients with overactive bladder.分析了基线平均值为每晚一次或多次尿失禁发作的患者（数据来自排尿日记）。比较每日一次奥昔布宁贴剂组和安慰剂组的平均排尿次数、每次排尿的平均排尿量、夜间平均首次排尿量、平均睡眠持续时间和无干扰睡眠小时数。所有参数表示为最小二乘mean values.ResultsThe分析包括576例患者。奥昔布宁贴剂组的失眠发作次数减少了0.66次，而安慰剂组减少了0.51次（P= 0.0249）。奥昔布宁贴剂组的夜间排尿量和夜间第一次排尿量也显著高于安慰剂组（P= 0.0073和P = 0.0005）。不受干扰的睡眠时间在奥昔布宁贴剂组中显示出76.14 min的显著延长，而在安慰剂组中为56.07 min（P= 0.0257）.ConclusionsOxybutynin贴剂治疗减少了膀胱过度活动症发作的次数，并减少了不受干扰的睡眠时间，从而改善了膀胱过度活动症患者的睡眠质量和睡眠相关的生活质量。
ObjectivesTo investigate the efficacy of a once‐daily oxybutynin patch for nocturia, and its influence on sleep quality in patients with overactive bladder.MethodsWe carried out post‐hoc analysis of a phase III, randomized, double‐blind, comparative study in which an oxybutynin patch was administered once daily for 12 weeks to Japanese patients with overactive bladder. Patients with a baseline mean of one or more episodes of nocturia per night (data from voiding diaries) were analyzed. The mean number of micturitions, mean voided volume per micturition, mean first voided volume at night, mean sleep duration, and hours of undisturbed sleep were compared between the once‐daily oxybutynin patch group and the placebo group. All parameters were expressed as the least squares mean values.ResultsThe analysis included 576 patients. The number of nocturia episodes decreased by 0.66 in the oxybutynin patch group versus 0.51 in the placebo group (P= 0.0249). Also, the voided volume per nocturnal micturition and the first voided volume at night showed a significant increase in the oxybutynin patch group compared with the placebo group (P= 0.0073 andP= 0.0005, respectively). The hours of undisturbed sleep showed significant prolongation by 76.14 min in the oxybutynin patch group versus 56.07 min in the placebo group (P= 0.0257).ConclusionsOxybutynin patch treatment reduces the number of nocturia episodes and prolongs the hours of undisturbed sleep, thus improving sleep quality and sleep‐related quality of life in patients with overactive bladder.