Department of Urology, Carolinas Rehabilitation, 1100 Blythe Boulevard, Charlotte, NC 28203, USA.
Urology. 2013 Mar;81(3):491-7. doi: 10.1016/j.urology.2012.11.010. Epub 2013 Jan 3.
To evaluate the long-term efficacy and safety of repeat onabotulinumtoxinA injections in patients inadequately managed by anticholinergics for urinary incontinence (UI) due to neurogenic detrusor overactivity.
Patients who completed either of 2 preceding phase III studies were offered entry into an extension study and received repeat onabotulinumtoxinA 200 U or 300 U. The data were integrated across the phase III and ongoing extension studies. The present interim analysis included all patients who received ≥ 1 onabotulinumtoxinA treatment. The data were analyzed by treatment cycle (cycles 1-5). The primary assessment was the change from baseline in UI episodes/wk at 6 weeks after each treatment. Additional assessments included ≥ 50% and 100% reductions in UI episodes, volume/void, Incontinence Quality of Life responses, and adverse events.
A total of 387, 336, 241, 113, and 46 patients received 1, 2, 3, 4, and 5 onabotulinumtoxinA treatments, respectively. The UI episodes/wk were consistently reduced compared with baseline after repeated onabotulinumtoxinA treatment (-22.7, -23.3, -23.1, -25.3, and -31.9 for the 200-U onabotulinumtoxinA group in cycles 1-5). The proportion of patients reporting ≥ 50% and 100% ("dry") reductions from baseline in UI episodes at week 6 ranged from 73%-94% and 36%-55%, respectively. Increases in the mean volume/void (mean increase >130 mL) and improvements in quality of life were also observed after repeat treatment. The most common adverse events were urinary tract infections and urinary retention, with no change in the adverse event profile over time.
The results of our study have shown that repeated onabotulinumtoxinA treatments provide sustained reductions in UI episodes and increases in the volume/void and quality of life in patients with neurogenic detrusor overactivity and UI who were inadequately managed by anticholinergics, with no new safety signals.
评估在抗胆碱能药物治疗神经源性逼尿肌过度活动相关尿失禁（UI）效果不佳的患者中，重复使用依替巴肽毒素 A 的长期疗效和安全性。
完成了 2 项 III 期研究的患者被纳入一项扩展研究，并接受重复使用 200U 或 300U 依替巴肽毒素 A。该数据在 III 期和正在进行的扩展研究中进行了整合。本次中期分析纳入了所有接受了≥1 次依替巴肽毒素 A 治疗的患者。数据按治疗周期（周期 1-5）进行分析。主要评估指标为每次治疗后 6 周时 UI 发作/周与基线相比的变化。其他评估指标包括 UI 发作、容量/排空、尿失禁生活质量的应答率≥50%和 100%，以及不良事件。
共有 387、336、241、113 和 46 名患者分别接受了 1、2、3、4 和 5 次依替巴肽毒素 A 治疗。与基线相比，重复依替巴肽毒素 A 治疗后，UI 发作/周持续减少（200U 依替巴肽毒素 A 组各周期 1-5 的降幅分别为-22.7、-23.3、-23.1、-25.3 和-31.9）。在第 6 周时，报告 UI 发作与基线相比≥50%和 100%（“干”）缓解的患者比例分别为 73%-94%和 36%-55%。重复治疗后，平均容量/排空（平均增加>130mL）也增加，生活质量得到改善。最常见的不良事件是尿路感染和尿潴留，随着时间的推移，不良事件的发生情况没有改变。
本研究结果表明，在抗胆碱能药物治疗效果不佳的神经源性逼尿肌过度活动相关尿失禁患者中，重复使用依替巴肽毒素 A 治疗可持续减少 UI 发作次数，并增加容量/排空和生活质量，且无新的安全信号。
