Department of Surgery/Urology, Tor Vergata University, Rome, Italy.
J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.
This is a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients with detrusor overactivity incontinence.
A total of 35 female patients presenting with detrusor overactivity incontinence that did not respond to antimuscarinic therapy were randomly assigned to percutaneous tibial nerve stimulation or to a control group. The percutaneous tibial nerve stimulation group (18 patients) was treated with 12 percutaneous tibial nerve stimulation sessions. The control group (17 patients) received an original placebo treatment using a 34 gauge needle placed in the medial part of the gastrocnemius muscle. The sessions lasted for 30 minutes and were performed 3 times weekly as percutaneous tibial nerve stimulation sessions. All patients were evaluated with bladder diaries as well as quality of life scores before and after treatment. Patients showing a reduction in urge incontinence episodes greater than 50% were considered responders.
Some patients (1 in the percutaneous tibial nerve stimulation group and 2 in the placebo group) did not complete the study for reasons not related to the technique. Of 17 patients in the percutaneous tibial nerve stimulation group 12 (71%) and of 15 in placebo group 0 were considered responders according to the previously reported definition (p <0.001). Improvement in the number of incontinence episodes, number of voids, voided volume and incontinence quality of life score were statistically significant in the percutaneous tibial nerve stimulation group but not in the placebo group.
Percutaneous tibial nerve stimulation can be considered an effective treatment for detrusor overactivity incontinence with 71% of patients considered responders, while none of those treated with placebo was considered a responder. The relevance of a placebo effect seems to be negligible in this patient population.
这是一项前瞻性、双盲、安慰剂对照研究，基于原始的安慰剂技术，旨在评估经皮胫神经刺激治疗女性逼尿肌过度活动型尿失禁的疗效。
共 35 名女性患者出现逼尿肌过度活动型尿失禁，经抗毒蕈碱治疗无效，随机分为经皮胫神经刺激组或对照组。经皮胫神经刺激组（18 例）接受 12 次经皮胫神经刺激治疗。对照组（17 例）接受原始安慰剂治疗，使用 34 号针放置在腓肠肌内侧。治疗持续 30 分钟，每周 3 次，作为经皮胫神经刺激治疗。所有患者在治疗前后均通过膀胱日记和生活质量评分进行评估。患者出现急迫性尿失禁发作减少超过 50%被认为是有反应者。
由于与技术无关的原因，一些患者（经皮胫神经刺激组 1 例，安慰剂组 2 例）未完成研究。17 例经皮胫神经刺激组中，12 例（71%）和 15 例安慰剂组中，0 例患者根据之前报道的定义被认为是有反应者（p<0.001）。经皮胫神经刺激组在尿急失禁发作次数、排尿次数、排尿量和尿失禁生活质量评分方面的改善具有统计学意义，但安慰剂组无此改善。
经皮胫神经刺激可作为治疗逼尿肌过度活动型尿失禁的有效方法，71%的患者被认为是有反应者，而安慰剂组无患者被认为是有反应者。在这种患者人群中，安慰剂效应的相关性似乎可以忽略不计。
