Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial
Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial
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DOI：
10.1016/j.juro.2009.12.036
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发表时间：
2010-04-01
影响因子：
6.6
通讯作者：
MacDiarmid, Scott A.
中科院分区：
文献类型：
--
作者：
Peters, Kenneth M.;Carrico, Donna J.;MacDiarmid, Scott A.
目的：紧急PC与假手术治疗膀胱过度活动症的有效性研究（SUmiT）是一项多中心、双盲、随机、对照试验，比较了经皮胫神经刺激与假手术治疗12周的有效性。改善全球反应评估，排尿日记参数，膀胱过度活动症和生活质量questionnaire进行了evaluated.Materials和方法：共220名成人膀胱过度活动症症状随机1：1至12周的治疗每周经皮胫神经刺激或假治疗。在基线和13周时完成膀胱过度活动症和生活质量问卷以及3天排尿日记。在第13周完成受试者总体反应评估。结果：13周受试者总体膀胱症状的总体反应评估表明，经皮胫神经刺激受试者的膀胱症状获得了统计学显著改善，54.5%的受试者报告中度或显著改善，而假手术受试者的这一比例为20.9%（p < 0.001）。与假手术相比，经皮胫神经刺激的所有个体总体反应评估子集症状成分从基线到13周均表现出统计学显着改善。治疗12周后的排尿日记参数显示，与假手术组相比，经皮胫神经刺激受试者在频率、夜间排尿、中度至重度尿急排尿和急迫性尿失禁发作方面有统计学显著性改善。没有严重的设备相关的不良事件或故障reported.Conclusions：这个关键的多中心，双盲，随机，假对照试验提供了一级证据，经皮胫神经刺激治疗是安全和有效的治疗膀胱过度活动症的症状。本试验中证实的经皮胫神经刺激的令人信服的疗效与最近发表的其他报告一致，并支持使用周围神经调节治疗膀胱过度活动症。
Purpose: The Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy. The improvement in global response assessment, voiding diary parameters, and overactive bladder and quality of life questionnaires was evaluated.Materials and Methods: A total of 220 adults with overactive bladder symptoms were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder and quality of life questionnaires as well as 3-day voiding diaries were completed at baseline and at 13 weeks. Subject global response assessments were completed at week 13.Results: The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p < 0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported.Conclusions: This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.