Clinical Consensus Statement: Vaginal Energy-Based Devices

The US Food and Drug Administration (FDA) announced a July 2018 public warning for using energy-based devices (EBDs) for performing vaginal cosmetic procedures or vaginal rejuvenation, based on both the imprecision of the term "vaginal rejuvenation" and the lack of FDA approval of the use of any devices such as lasers for any specific gynecologic indication. Some health care providers subspecializing in female reconstructive surgery and pelvic medicine deliver patient services via the EBDs discussed in the FDA Safety Communication. This clinical consensus statement (CCS) highlighted in this month's survey is intended to convey the American Urogynecologic Society's (AUGS's) findings in regard to the use of specific vaginal EBD technologies (eg, Er:YAG laser, fractionated CO2 laser, hybrid laser, radiofrequency) for the treatment of specific indications such as vaginal dryness, lichen sclerosis, and dyspareunia. The intent of this CCS is to help clinicians and patients in shared decision-making regarding these therapies, particularly in light of the FDA public warning. Importantly, this CCS is an update of a previous CCS by the same writing group from 2019. An information specialist from AUGS performed a structured review to identify current evidence regarding the indications, clinical outcomes, and treatment considerations for vulvovaginal EBD. The duration of the original search was November 2018 to January 2019 and included randomized controlled trials, clinical trials, systematic reviews, and practice guidelines publications in English from a variety of databases (eg, PubMed [MEDLINE], CMA Infobase [Canada], National Guideline Clearing house, SIGN [Scotland], NHS Evidence [United Kingdom], NICE [United Kingdom], TRIP database, Guideline International Network, New Zealand Guidelines Group, Cochrane Central Register of Controlled Trials, AMED, CINAHL, Web of Science, CAB Abstracts, BIOSIS Citation Index, and Agency for Healthcare Research and Quality). The search was updated in March 2022 for this updated CCS described here. A total of 40 statements relevant to EBD efficacy and safety were reviewed by the members of the AUGS EBD Writing Group. The group reached consensus on 28 statements, which means that the writing group agreed on either the presence or absence of data supporting the statement. The group was unable to reach consensus on the remaining 12 statements because of an absence of evidence in published literature. In the consideration of patient criteria, the EBD Writing Group found 100% agreement that (1) before any vulvovaginal EBD therapy, vaginal lesions, vulvar lesions, and/or cervical pathology should be excluded with absolute contraindication; (2) a possible indication for EBD could be in cases of inability to use vaginal estrogen treatment for vaginal dryness, vulvovaginal atrophy (VVA), or menopausal dyspareunia; and (3) a gynecologic examination should be performed within the year before initiating vaginal EBD therapy. Health care provider criteria reaching consensus included that (1) EBD therapy for vulvar and vaginal indications ought to be offered by professionals with relevant anatomical training, and (2) EBD therapy training standards should be established. Review of patient body image data demonstrated a lack of long-term objective data on EBD therapy's effect on vaginal or vulvar appearance. In addition, there is a lack of accepted definition for labial hypertrophy, as well as a paucity of evidenced efficacy for EBD treatment of this condition. In terms of safety considerations, reports of seriously adverse events following EBD therapy use are reported infrequently in association with treatment of VVA, menopausal dyspareunia, or vaginal dryness. Overall, EBD therapies maintain a favorable safety profile, but further data are needed in terms of long-term sequelae of vulvovaginal EBD therapies. Potential adverse events following such therapies may include spotting, bacterial vaginosis, discharge, scarring/burning (rare), or urinary tract infections. Information about significant performance characteristics for EBD was not found to be described to any extent in published literature, and the writing group could not form consensus on these statements. There no current evidence supporting treatment of pelvic irradiation-induced vaginitis via EBD therapy. Finally, the group raised a concern that wider use of these therapies could possibly result in lower-skill administration of treatment. Following a completion of the literature search, the AUGS EBD Writing Group failed to encounter substantial information on vulvovaginal EBD therapy being a cost-effective method. For treatment of lichen sclerosis, the writing group found an incomplete elucidation on the efficacy of EBD therapy. The group also came to consensus that EBD therapy lacked effectiveness in treating fecal incontinence. Further research is needed to determine the effectiveness of these therapies, with well-designed trials (including randomized controlled trials, trials with placebo treatment, sham-controlled trials, and/or active comparator trials vs vaginal estrogen) to determine benefits. A paucity of long-term data regarding their effectiveness hinders the ability of clinicians to determine their efficacy for VVA, dyspareunia, or vaginal dryness. However, the AUGS EBDWriting Group determined that these therapies may demonstrate effectiveness for treating lichen sclerosis. The AUGS EBDWriting Group determined that a significant knowledge gap exists regarding the safety and efficacy profile of vulvovaginal EBD therapies and their maintenance regimens, indications, contraindications, long-term benefits, and data comparing current treatments.