Peters Kenneth M, Macdiarmid Scott A, Wooldridge Leslie S, Leong Fah Che, Shobeiri S Abbas, Rovner Eric S, Siegel Steven W, Tate Susan B, Jarnagin Barry K, Rosenblatt Peter L, Feagins Brian A
William Beaumont Hospital, Royal Oak, Michigan, USA.
J Urol. 2009 Sep;182(3):1055-61. doi: 10.1016/j.juro.2009.05.045. Epub 2009 Jul 18.
The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated.
A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy.
The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions.
This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.
膀胱过度活动症创新疗法试验是一项随机、多中心、对照研究，比较了经皮胫神经刺激与托特罗定缓释片的疗效。评估了膀胱过度活动症症状的减轻情况以及整体反应评估结果。
共有100名尿频的成年人被随机分为1:1两组，一组接受为期12周的每周一次经皮胫神经刺激治疗，另一组接受每日4毫克托特罗定缓释片治疗。在基线和治疗结束时填写排尿日记和膀胱过度活动症问卷，以比较24小时排尿频率、尿急失禁发作次数、导致觉醒的排尿次数、排尿量、尿急发作次数和生活质量指标。治疗12周后，由受试者和研究者完成整体反应评估。
整体反应评估显示，与基线相比，经皮胫神经刺激组患者对膀胱过度活动症症状的评估具有统计学意义，79.5%的患者报告治愈或改善，而托特罗定组为54.8%（p = 0.01）。研究者的评估结果相似，但未达到统计学意义（p = 0.05）。治疗12周后，两组在尿频、尿急失禁发作次数、尿急严重程度和夜间排尿次数减少以及排尿量改善方面的客观指标改善情况相似。没有严重不良事件或设备故障。
这项多中心随机试验表明，经皮胫神经刺激是安全的，在患者对膀胱过度活动症症状的评估方面有统计学意义的改善，且客观疗效与药物治疗相当。经皮胫神经刺激可被视为膀胱过度活动症临床上有重要意义的替代疗法。
