Division of Urology, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.
Int Braz J Urol. 2010 Jan-Feb;36(1):66-74. doi: 10.1590/s1677-55382010000100011.
To report our experience with the use of the botulinum toxin-A (BoNT/A) formulations Botox and Prosigne in the treatment of neurogenic detrusor overactivity (NDO).
At a single institution, 45 consecutive patients with refractory urinary incontinence due to NDO received a single intradetrusor (excluding the trigone) treatment with botulinum toxin type A 200 or 300 units. Botox was used for the first 22 patients, and Prosigne for the subsequent 23 patients. Evaluations at baseline and week 12 included assessment of continence and urodynamics. Safety evaluations included monitoring of vital signs, hematuria during the procedure, hospital stay, and spontaneous adverse event reports.
A total of 42 patients were evaluated (74% male; mean age, 34.8 years). Significant improvements from baseline in maximum cystometric capacity (MCC), maximum detrusor pressure during bladder contraction, and compliance were observed in both groups (P < 0.05). Improvement in MCC was significantly greater with Botox versus Prosigne (+103.3% vs. +42.2%; P = 0.019). Continence was achieved by week 12 in 16 Botox recipients (76.2%) and 10 Prosigne recipients (47.6%; P = 0.057). No severe adverse events were observed. Mild adverse events included 2 cases of transient hematuria on the first postoperative day (no specific treatment required), and 3 cases of afebrile urinary tract infection.
Botox and Prosigne produce distinct effects in patients with NDO, with a greater increase in MCC with Botox. Further evaluation will be required to assess differences between these formulations.
报告我们使用肉毒杆菌毒素 A（BoNT/A）制剂 Botox 和 Prosigne 治疗神经源性逼尿肌过度活动（NDO）的经验。
在一家单中心机构中，45 例因 NDO 导致难治性尿失禁的连续患者接受了单次膀胱内（不包括三角区）肉毒毒素 A 200 或 300 单位治疗。前 22 例患者使用 Botox，随后 23 例患者使用 Prosigne。基线和 12 周时的评估包括对控尿和尿动力学的评估。安全性评估包括监测生命体征、手术过程中的血尿、住院时间和自发不良事件报告。
共评估了 42 例患者（74%为男性；平均年龄为 34.8 岁）。两组患者的最大膀胱容量（MCC）、膀胱收缩时最大逼尿肌压力和顺应性均较基线显著改善（P<0.05）。与 Prosigne 相比，Botox 组 MCC 的改善更为显著（+103.3%对+42.2%；P=0.019）。16 例 Botox 治疗患者（76.2%）和 10 例 Prosigne 治疗患者（47.6%）在 12 周时达到控尿（P=0.057）。未观察到严重不良事件。轻度不良事件包括 2 例术后第 1 天短暂血尿（无需特殊治疗）和 3 例无发热性尿路感染。
Botox 和 Prosigne 对 NDO 患者有不同的作用，Botox 可使 MCC 显著增加。需要进一步评估以评估这些制剂之间的差异。
