Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study
Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study
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DOI：
10.1016/j.juro.2016.03.146
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发表时间：
2016-09-01
影响因子：
6.6
通讯作者：
Chapple, Christopher
中科院分区：
文献类型：
--
作者：
Nitti, Victor W.;Ginsberg, David;Chapple, Christopher
目的：这些都是最终的结果的前瞻性，多中心，长期（3.5年）研究onabotulinumtoxinA的有效性/安全性膀胱过度活动综合征。材料和方法：患者谁完成了2，24周的3期试验，可以进入一个3年的扩展和继续治疗onabotulinumtoxinA 100 U需要控制膀胱过度活动症症状。按接受的治疗（最多6次）和接受1、2、3、4、5或6次治疗的离散亚组分析数据（以评价相同患者组重复治疗后缓解的一致性）。评估包括每日尿失禁发作次数较基线的变化和第12周TBS（治疗获益量表）报告泌尿系统症状改善/显著改善的患者比例，作为共同主要终点。其他终点为I-QOL较基线的变化（Incentive Quality of Life）、每天尿急和排尿次数、作用持续时间、不良事件次数以及间歇性导尿的开始。持续A型肉毒杆菌毒素治疗后，观察到尿失禁的平均减少，总体人群的范围为-3.1至-3.8，离散亚组的范围为-2.9至-4.5。在膀胱过度活动症症状和生活质量方面观察到持久的改善。高比例的患者将其病情评定为改善/大幅改善。中位效应持续时间为7.6个月。最常见的不良事件是尿路感染。第一次治疗后的从头导尿率为4.0%，它的范围从0.6%至1.7%，随后treatment.Conclusions：长期onabotulinumtoxinA治疗一致降低膀胱过度活动症的症状，改善生活质量，没有新的安全信号。
Purpose: These are the final results of the prospective, multicenter, long-term (3.5-year) study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome.Materials and Methods: Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment with onabotulinumtoxinA 100 U as needed to control overactive bladder symptoms. Data were analyzed by the treatment(s) received (up to 6) and in discrete subgroups that received 1, 2, 3, 4, 5 or 6 treatments (to evaluate the consistency of the response after repeat treatments in the same patient groups). Assessments included the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients who reported improvement/great improvement in urinary symptoms on the TBS (Treatment Benefit Scale) at week 12 as co-primary end points. Other end points were the change from baseline in I-QOL (Incontinence Quality of Life), the number of urgency and micturition episodes per day; duration of effect; the number of adverse events; and the initiation of intermittent catheterization.Results: Consistent mean reductions in urinary incontinence were observed following continued onabotulinumtoxinA treatment, ranging from -3.1 to -3.8 in the overall population and -2.9 to -4.5 in the discrete subgroups. Durable improvements were seen in overactive bladder symptoms and quality of life. A high proportion of patients rated their condition as improved/greatly improved. The median duration of effect was 7.6 months. The most common adverse event was urinary tract infection. The rate of de novo catheterization after the first treatment was 4.0% and it ranged from 0.6% to 1.7% after subsequent treatments.Conclusions: Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals.