Kavcic Niko, Avsenak Andrej, Zmazek Jan, Serdinsek Tamara, But Igor
Department of Urology, University Medical Centre Maribor, Maribor, Slovenia.
Faculty of Natural Sciences and Mathematics, University of Maribor, Maribor, Slovenia.
Wien Klin Wochenschr. 2024 Aug 23. doi: 10.1007/s00508-024-02412-7.
A non-inferiority clinical study evaluated the efficacy and safety of abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also, the effect of local anesthesia on the pain level of the procedure was assessed.
Patients were randomized to receive 20 intradetrusor injections of either 300 U abobotulinumtoxinA or 100 U incobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml 1% lidocaine solution) or placebo before botulinum toxin injection. Before the procedure and 4 months after the procedure each patient reported urinary incontinence episodes, frequency, nocturia, completed the Urogenital Distress Inventory (UDI-6) score, Incontinence Impact Questionnaire (IIQ-7), and Incontinence Quality of Life (I-QOL) questionnaire. Each patient completed a patient satisfaction survey 4 months after the procedure. During the procedure, the patients graded the pain intensity of every injection on a visual analog scale (VAS). The total score of each questionnaire was considered.
A total of 54 patients with a mean age of 66 ± 13 (SD) years completed the study. Total scores of UDI‑6, IIQ‑7, I‑QOL, patient satisfaction, urinary incontinence episodes, frequency, nocturia and VAS questionnaires did not show differences between the abobotulinumtoxinA (n = 26) or incobotulinumtoxinA (n = 28) group. Urinary retention requiring catheterization was noted in five patients. The VAS and patient satisfaction questionnaire values did not show significant differences between the group receiving bladder instillation with lidocaine solution (n = 28) or the group receiving placebo (n = 26).
In women with overactive bladder and urge urinary incontinence where conservative treatment failed, abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections showed comparable results regarding improved clinical outcome and patient satisfaction. Local anesthesia before the procedure did not reduce the pain level in comparison with the placebo.
一项非劣效性临床研究评估了阿柏他毒素A与因卡他毒素A膀胱逼尿肌内注射治疗膀胱过度活动症伴急迫性尿失禁女性的疗效和安全性。此外，还评估了局部麻醉对手术疼痛程度的影响。
患者被随机分为两组，分别接受20次膀胱逼尿肌内注射300 U阿柏他毒素A或100 U因卡他毒素A。在注射肉毒杆菌毒素前，他们又被进一步随机分为接受局部麻醉（40 ml 1%利多卡因溶液）或安慰剂组。在手术前和手术后4个月，每位患者报告尿失禁发作次数、频率、夜尿情况，完成泌尿生殖系统困扰量表（UDI-6）评分、尿失禁影响问卷（IIQ-7）和尿失禁生活质量（I-QOL）问卷。每位患者在手术后4个月完成患者满意度调查。在手术过程中，患者使用视觉模拟量表（VAS）对每次注射的疼痛强度进行评分。考虑每个问卷的总分。
共有54例平均年龄为66±13（标准差）岁的患者完成了研究。UDI-6、IIQ-7、I-QOL、患者满意度、尿失禁发作次数、频率、夜尿和VAS问卷的总分在阿柏他毒素A组（n = 26）和因卡他毒素A组（n = 28）之间没有差异。有5例患者出现需要导尿的尿潴留。在接受利多卡因溶液膀胱灌注的组（n = 28）和接受安慰剂的组（n = 26）之间，VAS和患者满意度问卷值没有显著差异。
在膀胱过度活动症伴急迫性尿失禁且保守治疗失败的女性中，阿柏他毒素A与因卡他毒素A膀胱逼尿肌内注射在改善临床结局和患者满意度方面显示出可比的结果。与安慰剂相比，手术前的局部麻醉并没有降低疼痛程度。
