Department of Urology, Beaumont Hospital, Royal Oak, Michigan 48073, USA.
J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
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.
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.
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.
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.
急迫性逼尿症与假刺激治疗效果对比研究（SUmiT）是一项多中心、双盲、随机、对照临床试验，旨在比较经皮胫神经刺激与假刺激治疗 12 周的疗效。通过评估整体反应评估、排尿日记参数、膀胱过度活动症和生活质量问卷，评估疗效。
共 220 名膀胱过度活动症患者被随机分为 1:1 组，分别接受 12 周每周一次的经皮胫神经刺激或假刺激治疗。治疗前及 13 周时填写膀胱过度活动症和生活质量问卷以及 3 天排尿日记。13 周时进行受试者整体反应评估。
13 周时，受试者整体反应评估显示，与假刺激组相比，经皮胫神经刺激组膀胱症状有显著改善，54.5%的患者报告中度或明显改善，而假刺激组为 20.9%（p<0.001）。与假刺激组相比，所有经皮胫神经刺激组个体整体反应评估症状均有显著改善。治疗 12 周后，排尿日记参数显示，与假刺激组相比，经皮胫神经刺激组在频率、夜间排尿、中度至重度尿急以及急迫性尿失禁发作方面有显著改善。未报告严重的设备相关不良事件或故障。
这项关键性、多中心、双盲、随机、假刺激对照临床试验提供了 I 级证据，表明经皮胫神经刺激治疗是安全有效的，可用于治疗膀胱过度活动症症状。该试验中经皮胫神经刺激的显著疗效与其他最近发表的报告一致，支持将外周神经调节治疗用于膀胱过度活动症。
