Unit of Functional and Surgical Urology, Department of Medical and Surgical Sciences and Neurosciences, University of Siena, Siena, Italy.
Urology Clinic, San Donato Hospital, Arezzo, Italy -
Minerva Urol Nephrol. 2022 Oct;74(5):625-635. doi: 10.23736/S2724-6051.21.04227-2. Epub 2021 Mar 26.
A randomized, double-blind, non-inferiority clinical study was performed on the efficacy and tolerability of IncobotulinumtoxinA (Incobot/A) vs. OnabotulinumtoxinA (OnabotA) intradetrusor injections in patients with refractory neurogenic detrusor overactivity incontinence performing intermittent catheterization.
Sixty-four patients with spinal cord injury (SCI) or multiple sclerosis were randomized to receive 30 intradetrusor injections of Incobot/A or OnabotA 200 U; 28 patients in incobotulinumtoxinA group and 29 in onabotulinumtoxinA group completed the study. Primary outcome measure was the non-inferior variation from baseline in daily urinary incontinence episodes (week 12), with a non-inferiority margin of one episode/day. Secondary outcomes measures were changes in Incontinence- Quality of Life questionnaire, Visual Analog Scale Score (bother of symptoms on Quality of Life), urodynamic parameters, occurrence of adverse effects and related costs (week 12).
At week 12, mean value of difference in urinary incontinence episodes/day between the two groups was -0.2 (95% two-sided CI: -1; 0.7); the difference in incontinence episodes/day between the two groups was -0.4 with a higher limit of one-sided 95% CI of 0.2 episodes/day which was much lower than the non-inferiority margin of one episode/day. Total score and subscores of Incontinence- Quality of Life questionnaire, Visual Analog Scale scores and urodynamics did not show differences between the two groups. Adverse effects were similar for both treatments, with urinary tract infection being the most frequent, localised effect. Minor costs were observed following Incobot/A.
In patients with refractory neurogenic incontinence due to SCI or multiple sclerosis, incobotulinumtoxinA was not inferior to onabotulinumtoxinA in improving clinical and urodynamic findings in the short-term follow-up, with comparable adverse effects but minor costs.
一项随机、双盲、非劣效性临床研究比较了特异地结合于 SNAP-25 的神经毒素 IncobotulinumtoxinA（Incobot/A）与特异地结合于 SNAP-25 的神经毒素 OnabotulinumtoxinA（OnabotA）在接受间歇性导尿的难治性神经源性逼尿肌过度活动型尿失禁患者中的疗效和耐受性。
64 例脊髓损伤（SCI）或多发性硬化症患者随机接受 30 次特异地结合于 SNAP-25 的神经毒素 Incobot/A 或 OnabotA（200U）膀胱内注射；28 例患者入 Incobot/A 组，29 例患者入 OnabotA 组完成了研究。主要终点为从基线开始的每日尿失禁发作的非劣效变化（第 12 周），非劣效界值为 1 次/日。次要终点为失禁生活质量问卷、视觉模拟评分（症状对生活质量的困扰）、尿动力学参数、不良反应的发生及相关费用（第 12 周）的变化。
第 12 周时，两组间每日尿失禁发作的差异平均值为-0.2（95%双侧 CI：-1；0.7）；两组间失禁发作的差异平均值为-0.4，单侧 95%CI 的上限为 0.2 次/日，远低于 1 次/日的非劣效界值。失禁生活质量问卷的总分和各分量表评分、视觉模拟评分和尿动力学均未显示两组间的差异。两种治疗的不良反应相似，最常见的是局部尿路感染。观察到 Incobot/A 后轻微的费用。
在因 SCI 或多发性硬化症而导致难治性神经源性尿失禁的患者中，IncobotulinumtoxinA 在短期随访中改善临床和尿动力学发现方面不劣于 OnabotulinumtoxinA，具有可比较的不良反应但费用较低。
