OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised, Double-Blind, Placebo-Controlled Trial
OnabotulinumtoxinA 100 U Significantly Improves All Idiopathic Overactive Bladder Symptoms and Quality of Life in Patients with Overactive Bladder and Urinary Incontinence: A Randomised, Double-Blind, Placebo-Controlled Trial
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DOI：
10.1016/j.eururo.2013.04.001
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发表时间：
2013-08-01
期刊：
影响因子：
23.4
通讯作者：
Haag-Molkenteller, Cornelia
中科院分区：
文献类型：
--
作者：
Chapple, Christopher;Sievert, Karl-Dietrich;Haag-Molkenteller, Cornelia
背景：伴有尿失禁 (UI) 的膀胱过度活动症 (OAB) 综合征在人群中普遍存在，并损害健康相关的生活质量 (HRQOL)。 目的：评估肉毒杆菌毒素 A（BOTOX (R)，Allergan, Inc.）治疗对患有 UI 的 OAB 患者的疗效、安全性和 HRQOL 的影响。设计、环境和参与者：这项关键、多中心、双盲、随机、安慰剂对照的第 3 期研究纳入了特发性 OAB 患者，这些患者在 3 天内出现 >= 3 次尿急发作且每天排尿次数 >= 8 次，且抗胆碱能药物治疗效果不佳。干预：肉毒杆菌毒素 A 100 U 剂量 (n = 277) 或安慰剂 (n = 271)，按 20 次 0.5 ml 的逼尿肌内注射给药。测量和统计分析：共同主要终点是每天 UI 发作次数相对于基线的变化，以及第 12 周时在治疗获益量表 (TBS) 上报告阳性治疗反应的患者比例。其他终点包括其他 OAB 症状（尿急性尿失禁、排尿、尿急和夜尿发作）和 HRQOL（失禁生活质量 [I-QOL]、国王健康问卷 [KHQ]）。安全性评估包括不良事件 (AE)、排尿后残余尿量 (PVR) 以及开始清洁间歇导尿 (CIC)。结果和局限性：第 12 周时 OnabotulinumtoxinA 显着减少每天 UI 发作次数（OnabotulinumtoxinA 为 -2.95，安慰剂为 -1.03；p < 0.001）。与安慰剂相比，使用肉毒杆菌毒素 A 后所有其他 OAB 症状相对于基线的减少也显着更大 (p
Background: Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL).Objective: To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX (R), Allergan, Inc.) treatment in patients with OAB with UI.Design, setting, and participants: This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with >= 3 urgency UI episodes over 3 d and >= 8 micturitions per day who were inadequately managed by anticholinergics.Intervention: OnabotulinumtoxinA at a 100 U dose (n = 277) or placebo (n = 271), administered as 20 intradetrusor injections of 0.5 ml.Outcome measurements and statistical analysis: Co-primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC).Results and limitations: OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p < 0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p