From the Female Pelvic Medicine & Reconstructive Surgery, Women's Health & Surgery Center of Advantia Health, Stafford, VA.
Division of Urogynecology & Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology, & Reproductive Science Yale University School of Medicine, New Haven, CT.
Urogynecology (Phila). 2022 Aug 1;28(8):518-525. doi: 10.1097/SPV.0000000000001199. Epub 2022 May 12.
Intradetrusor injection of onabotulinumtoxinA is performed via varying injection paradigms but no studies have studied the various effects of these paradigms on patient experience with the procedure.
This randomized clinical trial aims to compare pain and procedure time between patients receiving a 100-unit dose of onabotulinumtoxinA in 5 injections compared to 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence.
Patients presenting with refractory overactive bladder or urgency urinary incontinence at 2 clinical sites were identified and randomized to undergo onabotulinumtoxinA treatment with 5 injections versus 20 injections. Patients rated their pain level on a 10-point visual analog scale at procedure completion. The procedure duration was recorded with a stopwatch. Patients were followed up 6 weeks postprocedure, at which time they completed a Global Response Assessment to determine subjective efficacy of treatment. Participants were additionally monitored for incidence of adverse events in the follow-up period.
The average pain score was not statistically significant between groups (2; interquartile range, 1-4 for the 5 injection group vs 3; interquartile range, 2-4 for the 20 injection group; P = 0.27). Patients who received 5 injections experienced significantly shorter mean procedure time as compared with patients who received 20 injections (76 seconds vs 176 seconds; P < 0.001). There were no differences in subjective efficacy or adverse events between groups.
Perceived pain, efficacy, and postprocedure complications did not significantly differ between patients receiving 5 injections and 20 injections, but procedure time was significantly shorter.
经尿道内注射肉毒毒素 A 是通过不同的注射模式进行的，但尚无研究探讨这些模式对患者接受该程序体验的各种影响。
本随机临床试验旨在比较接受 100 单位剂量肉毒毒素 A 治疗的患者在 5 次注射与 20 次注射治疗特发性逼尿肌过度活动症或急迫性尿失禁时的疼痛和程序时间。
在 2 个临床地点，识别出有难治性逼尿肌过度活动症或急迫性尿失禁的患者，并将其随机分为接受 5 次注射与 20 次注射的肉毒毒素 A 治疗组。患者在程序完成时使用 10 分制视觉模拟量表评定疼痛程度。使用秒表记录程序持续时间。患者在术后 6 周进行随访，此时他们完成了一项总体反应评估，以确定治疗的主观疗效。在随访期间，还监测参与者发生不良反应的情况。
两组间平均疼痛评分无统计学意义（5 次注射组为 2 分[四分位距，1-4]，20 次注射组为 3 分[四分位距，2-4]；P = 0.27）。与接受 20 次注射的患者相比，接受 5 次注射的患者的平均程序时间明显更短（76 秒比 176 秒；P < 0.001）。两组间在主观疗效或不良反应方面无差异。
接受 5 次注射和 20 次注射的患者在疼痛、疗效和术后并发症方面没有显著差异，但程序时间明显更短。
