SOCIETY POSITION STATEMENTS Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine Javier Romero-Otero, PhD, 1,2 Roy Lauterbach, PhD, 3 Antonio Aversa, PhD, 4 Ege Can Serefoglu, MD, 5 Borja García-Gómez, MD, 1 Arie Parnhan, MD, 6 Marta Skrodzka, MD, 7 Michael Krychman, PhD, 8 Yacov Reisman, PhD, 9 Giovanni Corona, PhD, 10 and Lior Lowenstein, PhD 3 ABSTRACT Introduction: 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 meno- pause, and symptoms of urinary incontinence and sexual function on July 30, 2018. Aim: To perform a thorough review of the existing literature regarding RF-based vaginal devices for the treat- ment of female genitourinary indications and summarize the evidence available in a few short statements. Methods: A thorough review of the literature regarding RF treatments for gynecological indications was per- formed based on several databases. Studies that included at least 15 patients were eligible for analysis. Main Outcome Measure: Efficacy of RF devices for different genitourinary indications. Results: 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. Clinical Implications: 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. Conclusions: 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;17:393e399. Copyright Ó 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. Key Words: Efficacy; Genitourinary Indications; Radiofrequency; Safety INTRODUCTION Radiofrequency (RF) treatments have become increasingly popular during the last several years as alternative nonsurgical tissue remod- eling treatment modalities in the field of sexual and gynecological medicine. These techniques have been commercially promoted as effective for various gynecological indications including alleviation of genitourinary syndrome of menopause (GSM) symptoms and treatment of stress urinary incontinence (SUI) and vaginal laxity. 1e3 Received September 26, 2019. Accepted December 11, 2019. 1 Urology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; 2 Hospital Universitario HM Montepríncipe, Boadilla del Monte, Madrid, Spain; 3 Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; 4 Department of Experimental and Clinical Medicine, Magna Graecia Uni- versity of Catanzaro Magna Graecia, Catanzaro, Italy; 5 Department of Urology, Bahceci Health Group, Istanbul,Turkey; 6 The Christie NHS Foundation Trust, Manchester, UK; 7 Andrology Department, University College, London, UK; 8 Southern California Center for Sexual Health and Survivorship Medicine, CA, USA; 9 Flare-Health, Amstelveen, the Netherlands; 10 Endocrinology Unit, Medical Department, Azienda USL, Maggiore-Bellaria Hospital, Bologna, Italy Copyright ª 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2019.12.015 J Sex Med 2020;17:393e399 393 Downloaded from https://academic.oup.com/jsm/article/17/3/393/6973537 by guest on 13 January 2023