Xu Zhi-Hui, Zhang Peng-Fei, Wang Yu-Feng, Ma Ao, Bano Yasmeen, Ibrohimov Alisherjon, Zhang Chen, Jiang Hao-Fei, Zhang Yang, Yu Yan-Lan, Jiang Hai-Hong
Zhejiang Provincial People's Hospital, Hangzhou, China.
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Front Med (Lausanne). 2022 May 12;9:746064. doi: 10.3389/fmed.2022.746064. eCollection 2022.
The purpose of this study was to evaluate the efficacy and safety of low power micro radiofrequency (RF) therapy (μRFthera) through urethra in the treatment of overactive bladders (OAB) through a prospective, single-blind, placebo-controlled, multi-center clinical protocol.
One hundred and fourteen patients with refractory OAB were randomized at 2:1 ratio, treatment to control undergoing same procedures except only the micro-RF treatment group at turned "on" setting in energy. Bladder diaries recorded during the screening period (3 days before enrollment) and during follow-up period on week 1, 3, and 7, respectively. The patients in control could choose receiving an energized treatment during extension stage.
The treatment efficacy was 76.1%. There was 49.80% rate improvement compared to control (95%CL 32.48%, 67.13%). The crude rate ration (RR) was 2.89, 95% CI (1.67-5.01) with < 0.001 in uni-variate analysis, while the RR became 2.94, 95% CI (1.67-5.16) with < 0.001 after adjusted potential confounding factors in multi-variate analysis. Statistically significant improvements have been demonstrated in the frequency of urination, urgency, nocturia, and quality of life (QoL) scores.
Micro RF therapy is safe and effective for the treatment of OAB. The main treatment-related complications were catheterization related complications.
Zhejiang Device Registration Certificate No. 202090909, www.chictr.org.cn, Clinical Trial Accession Number: ChiCTR2100050096.
本研究旨在通过一项前瞻性、单盲、安慰剂对照、多中心临床方案，评估经尿道低功率微射频（RF）治疗（μRFthera）在治疗膀胱过度活动症（OAB）中的疗效和安全性。
114例难治性OAB患者按2:1比例随机分组，治疗组与对照组接受相同程序，除微射频治疗组在能量设置上为“开启”状态。分别在筛查期（入组前3天）以及随访期第1周、第3周和第7周记录膀胱日记。对照组患者在延长期可选择接受一次通电治疗。
治疗有效率为76.1%。与对照组相比，改善率为49.80%（95%可信区间32.48%，67.13%）。单因素分析中粗率比（RR）为2.89，95%可信区间（1.67 - 5.01），P<0.001；多因素分析中在调整潜在混杂因素后，RR变为2.94，95%可信区间（1.67 - 5.16），P<0.001。在排尿频率、尿急、夜尿症和生活质量（QoL）评分方面已证明有统计学显著改善。
微射频治疗对OAB的治疗安全有效。主要的治疗相关并发症是与导尿相关的并发症。
浙江医疗器械注册证号202090909，www.chictr.org.cn，临床试验注册号：ChiCTR2100050096。
