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王建勝 使用帶有六個電極的薦骨神經電刺激治療頑固性膀胱過動症:多中心、隨機、單盲、對照試驗 2022/9/2 下午 05:57:22 0
原 文 題  目 Sacral Neuromodulation Using a Novel Device with a Six–contact-point Electrode for the Treatment of Patients with Refractory Overactive Bladder: A Multicenter, Randomized, Single-blind, Parallel-control Clinical Trial
作  者 Limin Liao , Zhonghan Zhou , Guoqing Chen , Zhihui Xu , Banggao Huang , Tie Chong , Qi Chen , Zhongqing Wei , Baixin Shen , Zhong Chen , Qing Ling , Zhiliang Weng , Haihong Jiang , Benkang Shi , Yan Li , Yiming Wang
出  處 Eur Urol Focus, S2405-4569(22)00083-9.
出版日期 4 MAY, 2022
評 論 膀胱過動症是台灣最常見的疾病之一,大概每5人就有1人會有這樣的問題,這類的病人通常會表現無法控制地尿急,小便次數頻繁但尿量少,剛小便完就有解不乾淨的感覺,嚴重影響病患的生活品質,因為頻繁的想上廁所,無法開車到較遠的地方,也沒辦法進行社交活動,甚至可能會覺得沮喪憂鬱,而有自殺的念頭。目前針對膀胱過動症的治療以藥物治療為主,另外還有行為治療和骨盆肌肉電刺激等,但仍有一部分的病患沒辦法改善症狀或無法忍受藥物的副作用而失望、沮喪。薦骨神經電刺激(Sacral Nerve Stimulation)是透過電流調控和排尿反射相關的神經來治療排尿障礙,在這篇文章中,透過植入六個電極的薦骨神經電刺激設備,在十二週的追蹤中有56%的病人可以減少24小時內的排尿次數到50%,並且可以改善每次排尿的排尿量和減少急迫性尿失禁的發生。這個研究提供了一個頑固性膀胱過動病患在治療上一個新的嚐試,病人有頻尿急尿問題建議盡快就醫診斷及治療,不要一直將其歸咎於老化,和醫生一起找到對你對好的治療方式,才能徹底治癒擾人的尿尿問題!
abstract Abstract
Background: A novel sacral neuromodulation system (SacralStim) which has an electrode with six contact points was recently designed.
Objective: To evaluate the effectiveness and safety of the SacralStim system for treating patients with refractory overactive bladder (OAB).
Design, setting, and participants: This was a multicenter, randomized, single-blind clinical trial. Patients with refractory OAB were enrolled from January 2018 to May 2020. Participants were randomly allocated to the treatment group (SNM on) or the control group (SNM off) for a single-blind period of 12 ± 2 wk.
Outcome measurements and statistical analysis: The primary outcome was the percentage of patients with a reduction in the average number of voids/24 h of at least 50% at the 12-wk follow-up visit. Other follow-up evaluations, including voiding diary outcomes, questionnaires on Overactive Bladder Symptom Score (OABSS), quality of life (QoL), device satisfaction, and causes of adverse events (AEs), were performed over the first 48 wk after implantation.
Results and limitations: The therapeutic success rate at 12 wk was 56.76% in the treatment group and 11.11% in the control group (p < 0.001). There were significant differences in voiding diary variables between the two groups, including changes in the average number of voids/24 h, micturition volume/void, and improvement in the urge incontinence ratio. No severe AEs occurred. A limitation is the sham stimulation used as a control in the study. A head-to-head study is required to make a direct comparison of devices with six and four contact points.
Conclusions: This clinical trial provides strong evidence that patients with refractory OAB benefit from the novel SacralStim system. More research is required for direct comparison of the SacralStim system with traditional four-contact-point devices.
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