Vaginal Energy-Based Devices

Abstract

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society’s EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Fractional‐Pixel CO2 Laser Treatment in Patients With Urodynamic Stress Urinary Incontinence: 1‐Year Follow‐Up

“…The recent consensus paper published by Alsheiek et al [27] concluded that a short‐term benefit could be achieved after a fractional laser, but most studies lack long‐term follow‐up and control groups. Our study differs from previous reports given its longer follow‐up period of 12 months, and by the addition of well‐accepted validated outcome measures, including subjective, objective, and histological parameters.…”

An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain

“…As expected, the complication rates were low and the most commonly reported side effect was temporary noninfectious vaginal discharge. Although larger studies are needed, this initial report should alleviate concerns for major complications such as vaginal burns or scarring described with ablative vaginal laser therapy [23,24].…”

“…The SoLá Pelvic Therapy Laser is a nonablative class IV NIR laser capable of transmitting both 810 and 980 nm wavelengths to pelvic structures [21]. The nonionizing and nonthermal effect emitted by the device avoids the serious side effects such as vaginal scarring and burns reported [22] when traditional lasers (CO 2 and Er: Yag lasers) are used to treat vaginal conditions such as atrophy, laxity and incontinence [23,24].…”

2021 Update on female sexual health

“…The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for "routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit." 2 In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia.…”

“…But we only have outcomes data that lasts a maximum of 1 year. 2 A problem with our VeLVET trial, 3 which was published in Menopause, and the Cruz and colleagues' trial from South America, 4 both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up.…”