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

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.