AUTHOR=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 

TITLE=A Multi-Center, Randomized, Blind, Controlled Clinical Trial of the Safety and Efficacy of Micro Radio Frequency Therapy System for the Treatment of Overactive Bladder

JOURNAL=Frontiers in Medicine

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.746064

DOI=10.3389/fmed.2022.746064

ISSN=2296-858X

ABSTRACT=<sec><title>Purpose</title><p>The purpose of this study was to evaluate the efficacy and safety of low power micro radiofrequency (RF) therapy (μRFthera<sup>®</sup>) through urethra in the treatment of overactive bladders (OAB) through a prospective, single-blind, placebo-controlled, multi-center clinical protocol.</p></sec><sec><title>Materials and Methods</title><p>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.</p></sec><sec><title>Results</title><p>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 <italic>p</italic> &lt; 0.001 in uni-variate analysis, while the RR became 2.94, 95% CI (1.67–5.16) with <italic>p</italic> &lt; 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.</p></sec><sec><title>Conclusions</title><p>Micro RF therapy is safe and effective for the treatment of OAB. The main treatment-related complications were catheterization related complications.</p></sec><sec><title>Clinical Trial Registration</title><p>Zhejiang Device Registration Certificate No. 202090909, <ext-link ext-link-type="uri" xlink:href="http://www.chictr.org.cn" xmlns:xlink="http://www.w3.org/1999/xlink">www.chictr.org.cn</ext-link>, Clinical Trial Accession Number: ChiCTR2100050096.</p></sec>