Urology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; Hospital Universitario HM Montepríncipe, Boadilla del Monte, Madrid, Spain.
Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.
J Sex Med. 2020 Mar;17(3):393-399. doi: 10.1016/j.jsxm.2019.12.015.
Radiofrequency (RF)-based treatment has been introduced as an esthetic alternative treatment for various medical indications without the scientific backup of a satisfactory body of evidence. Furthermore, the United States Food and Drug Administration issued a warning regarding the safety of energy-based technologies for indications such as vaginal "rejuvenation," cosmetic vaginal treatment, vaginal conditions related to menopause, and symptoms of urinary incontinence and sexual function on July 30, 2018.
To perform a thorough review of the existing literature regarding RF-based vaginal devices for the treatment of female genitourinary indications and summarize the evidence available in a few short statements.
A thorough review of the literature regarding RF treatments for gynecological indications was performed based on several databases. Studies that included at least 15 patients were eligible for analysis.
Efficacy of RF devices for different genitourinary indications.
Although a high level of heterogeneity of studies poses a serious challenge, the committee reached a decision on several statements related to the use of RF-based devices for genitourinary indications.
RF-based vaginal treatments have not been studied thoroughly enough in order to establish decisive recommendations regarding their safety and efficacy.
STRENGTH & LIMITATIONS: These position statements have been established by a group of experts. The lack of strong evidence makes it difficult to give decisive recommendations.
Further randomized controlled trials with proper methodology and design are required to establish both benefits and possible harm these treatments may have in both short and long term for all the different indications studied. Otero JR, Lauterbach R, Aversa A, et al. Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine. J Sex Med 2020;17:393-399.
射频（RF）治疗已作为一种替代治疗方法引入，用于治疗各种医学病症，但缺乏令人满意的证据支持。此外，美国食品和药物管理局于 2018 年 7 月 30 日发布了一则警告，称能量技术的安全性存在问题，不建议将其用于阴道“年轻化”、美容阴道治疗、与绝经相关的阴道状况以及尿失禁和性功能障碍等病症的治疗。
对现有关于射频阴道设备治疗女性泌尿生殖系统疾病的文献进行全面回顾，并以简短陈述的形式总结现有证据。
根据多个数据库对射频治疗妇科疾病的文献进行了全面回顾。符合分析标准的研究至少纳入了 15 名患者。
射频设备治疗不同泌尿生殖系统疾病的疗效。
尽管研究的异质性水平较高，这给决策带来了严峻挑战，但委员会就射频设备用于泌尿生殖系统疾病的一些声明达成了一致意见。
射频阴道治疗的安全性和疗效尚未得到充分研究，因此无法做出明确的推荐。
这些立场声明是由一组专家制定的。由于缺乏强有力的证据，难以给出明确的建议。
需要进一步开展具有适当方法学和设计的随机对照试验，以确定这些治疗方法在所有研究的不同适应证中短期和长期的获益和潜在危害。
