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Laser-Based Devices for Female Genitourinary Indications: Position Statements From the European Society for Sexual Medicine (ESSM)

Romero-Otero J1Lauterbach R2Aversa A3Serefoglu EC4García-Gómez B5Parnham A6Skrodzka M7Krychman M8Reisman Y9Corona G10Lowenstein L2.

J Sex Med. 2020 Mar 19. pii: S1743-6095(20)30117-X. doi: 10.1016/j.jsxm.2020.02.013. [Epub ahead of print]

Abstract

BACKGROUND:

Laser-based technologies have been commercially marketed as «wonder treatments» without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal «rejuvenation» or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function.

AIM:

To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence.

METHODS:

A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients.

OUTCOMES:

Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed.

RESULTS:

Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications.

CLINICAL IMPLICATIONS:

Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established.

STRENGTHS & LIMITATIONS:

All studies have been evaluated by a panel of experts providing recommendations for clinical practice.

CONCLUSION:

It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.