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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
PURPOSE: 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. MATERIALS AND...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9133845/ https://www.ncbi.nlm.nih.gov/pubmed/35646944 http://dx.doi.org/10.3389/fmed.2022.746064 |
Sumario: | PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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 p < 0.001 in uni-variate analysis, while the RR became 2.94, 95% CI (1.67–5.16) with p < 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. CONCLUSIONS: Micro RF therapy is safe and effective for the treatment of OAB. The main treatment-related complications were catheterization related complications. CLINICAL TRIAL REGISTRATION: Zhejiang Device Registration Certificate No. 202090909, www.chictr.org.cn, Clinical Trial Accession Number: ChiCTR2100050096. |
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