OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.
OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.
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DOI：
10.1016/j.juro.2016.10.109
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发表时间：
2017-02-01
期刊：
影响因子：
--
通讯作者：
Haag-Molkenteller, Cornelia
中科院分区：
文献类型：
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作者：
Nitti, Victor W;Dmochowski, Roger;Haag-Molkenteller, Cornelia
目得：膀胱过度活动症影响12%至17%的普通人群，几乎三分之一的人会出现尿失禁，这可能会严重影响与健康相关的生活质量。口服抗胆碱能药物是药物治疗的主要手段，但由于疗效不足或副作用，导致停药率较高。我们报告的结果，第一个大的（557名患者），3期，安慰剂对照试验，在膀胱过度活动症和尿失禁患者中使用抗胆碱能药物治疗不充分。材料和方法：合格的膀胱过度活动症患者，3天内3次或更多次紧急尿失禁发作和每天8次或更多次排尿被随机1：1例接受逼尿肌内注射肉毒毒素A 100 U或安慰剂。共同主要终点为每日尿失禁发作次数较基线的变化和治疗后第12周治疗获益量表阳性反应的患者比例。次要终点包括其他膀胱过度活动症症状和健康相关的生活质量。结果：与安慰剂相比，OnabotulinumtoxinA显著降低了尿失禁发作的每日频率（-2.65 vs-0.87，p
PURPOSE: Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics.MATERIALS AND METHODS: Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed.RESULTS: OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (-2.65 vs -0.87, p