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J Sex Med. 2020 Mar;17(3):393-399. doi: 10.1016/j.jsxm.2019.12.015.

Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine.

Author information

1
Urology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; Hospital Universitario HM Montepríncipe, Boadilla del Monte, Madrid, Spain. Electronic address: jromerootero@hotmail.com.
2
Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.
3
Department of Experimental and Clinical Medicine, Magna Graecia University of Catanzaro Magna Graecia, Catanzaro, Italy.
4
Department of Urology, Bahceci Health Group, Istanbul, Turkey.
5
Urology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
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.

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 menopause, 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 treatment 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 performed 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;17:393-399.

KEYWORDS:

Efficacy; Genitourinary Indications; Radiofrequency; Safety

PMID:
32129169
DOI:
10.1016/j.jsxm.2019.12.015

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