Dr. Michael Gold discusses medical versus aesthetic use of devices for treating women’s concerns, such as urinary incontinence, with an emphasis on those backed by scientific research.
Michael H. Gold, MD, Medical Director, Gold Skin Care Center, and Tennessee Clinical Research Center, Nashville, Tennessee
“We’ve had this exciting treatment scenario for several years where we can use devices with radio frequencies, LED, or even fractional lasers to treat certain diseases and symptoms that women have,” said Michael H. Gold, MD, who presented “Optimizing Women’s Health From the Dermatology Side” during the Optimizing Women’s Health session at ASLMS 2023 in Phoenix, Arizona.
About 5 years have passed since the FDA’s crackdown on what the agency called deceptive health claims and significant risks related to devices marketed for “vaginal rejuvenation,”1 Dr. Gold said.
“… some of the companies got into publicizing their devices or treatment techniques more in the aesthetic-cosmetic arena instead of focusing on medical needs. So instead of urinary incontinence, pelvic floor disorders, and painful intercourse, they were focusing on rejuvenation effects. The FDA cracked down really hard, which was appropriate, saying you can’t do things without having the proper labels from the FDA, which these companies didn’t have. So, a lot of the excitement and interest in this area died … but the therapies remained valid and good.”
Since then, a few device companies have complied with the FDA and conducted studies looking at using the devices for women’s health indications. According to Dr. Gold, these are among the science-backed devices:
Joylux: vSculp LED
Researchers reviewing the biologic basis of the Joylux photobiomodulation therapy (PBMT) take-home device for the management of genitourinary syndrome of menopause wrote that preliminary evidence suggests PBMT is safe and appears to be efficacious in treating genitourinary syndrome.2
ThermiAesthetics: ThermiVA
Researchers studying the ThermiVA monopolar radiofrequency device efficacy and safety in the treatment of vulvovaginal laxity and sexual dysfunction found “ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period.”3
Cynosure: Tempsure Vitalia
Researchers comparing the effects of Inmode’s Votiva FormaV bipolar radiofrequency device with ThermiVA and Tempsure Vitalia for treatment of urinary stress incontinence found a “clear benefit,” from both monopolar devices. But evidence from the retrospective study suggests the bipolar group improved more, according to Dr. Gold.4
Alma: FemiLift Pixel CO2
According to Dr. Gold, in studies on the FemiLift Alma Pixel CO2 fractional laser, researchers concluded, “The CO2 lattice laser is safe and effective in the treatment of mild and moderate urinary incontinence in female patients, which can effectively improve the symptom of urinary leakage without obvious adverse reactions.”5
There is also a role for some lasers in more invasive procedures, said Dr. Gold.
“Ablative fractional lasers, erbium, and CO2-type lasers play a role in a more invasive procedure compared to radiofrequency but can be used to treat not only issues like urinary incontinence but also dermatologic diseases. Fractional lasers, for example, are a good and needed therapeutic option for lichen sclerosis.”
Dermatologists who want to incorporate laser and light devices into practice for women’s health should know the science, he said.
“You need to know [for each device that] it takes this number of treatments and you get this amount of improvement and that it’s sustainable for this amount of time. That’s what these clinical trials are all about.”
About 20 devices were promoted for vaginal rejuvenation or women’s health before the FDA warning, he said.
“The reality is only a few of them had anything science related behind them.”
References:
- FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” | FDA. November 15, 2017. Accessed June 19, 2023.
- Lanzafame RJ, de la Torre S, Leibaschoff GH. The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Photobiomodul Photomed Laser Surg. 2019;37(7):395-407. doi:10.1089/photob.2019.4618.
- Pather K, Dilgir S, Rane A. The ThermiVa In Genital Hiatus Treatment (TIGHT) Study. Sex Med.2021;9(6):100427. doi:10.1016/j.esxm.2021.100427.
- Abdelaziz A, Dell J, Karram M. Transvaginal radiofrequency energy for the treatment of urinary stress incontinence: A comparison of monopolar and bipolar technologies in both pre- and post-menopausal patients. Neurourol Urodyn. 2021;40(7):1804-1810. doi:10.1002/nau.24748.
- Zhang L, Lai Y, Pan W, et al. Application of ultra pulse CO2 lattice laser in the treatment of female urinary incontinence. Transl Androl Urol. 2021;10(6):2471-2477. doi:10.21037/tau-21-337.
Disclosures: Dr. Gold is a consultant for Joylux, Thermi, and Alma Lasers.