Light and energy‐based therapeutics for genitourinary applications: Consensus on protocols and best practices

Abstract

Background: Lasers and energy-based technologies have been developed for genitourinary applications over the past several decades. Aims: This consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials. Materials and Methods: The published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters.Results: The devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition. Discussion: The status of FDA clearances and future pathways are discussed. Conclusions: This consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.

Lasers in Gynecology

“…Table 2 includes currently available fractionated laser options and dates of clearance for use by the FDA through the 510k process, meaning that the lasers were cleared on the basis of similar prior predicate devices. 25…”

“…Many studies have demonstrated feasibility, tolerability, and positive effects of vaginal laser on genitourinary conditions; however, data quality has been deemed low and very low, and higher-quality clinical trials are needed to change current clinical practice recommendations. A recent consensus article by Alexiades et al 25 reviewed clinical trial data for lasers on genitourinary conditions and aimed to develop protocols and practices for the use of laser in future clinical trials, which may allow comparable data and meta-analyses. The consensus document lists common brands of CO 2 and Er:YAG laser devices and their manufacturer-recommended settings and describes a treatment schedule of three treatments at 1-month intervals, with a maintenance treatment between 6 and 12 months of follow-up.…”

“…Table 2 includes currently available fractionated laser options and dates of clearance for use by the FDA through the 510k process, meaning that the lasers were cleared on the basis of similar prior predicate devices. 25 Although lasers have been cleared for mostly general soft tissue use in a multitude of medical and surgical specialties, as listed in Table 2, lasers have not been approved for specific genitourinary conditions such as vulvovaginal atrophy, vulvar skin conditions, including lichen sclerosus, and urinary incontinence. This clinical expert review article outlines the current safety and effectiveness data for fractionated laser treatments of these conditions.…”