At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause

November 2020 | Volume 19 | Issue 11 | Original Article | 1076 | Copyright © November 2020


Macrene Alexiades MD PhD

Yale University School of Medicine, New Haven, CT
Dermatology and Laser Surgery Center of New York, New York, NY

Abstract
Background: Device-based therapeutic approaches have been developed to treat women’s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment.
Objective: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM).
Study Design: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser).
Methods: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms.
Results: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P<0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P<0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P<0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P<0.05).
Conclusions: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.

J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012

INTRODUCTION

Device-based therapeutic approaches are being focused on women’s genitourinary health to provide hormone-free non-surgical treatment alternatives for menopausal vaginal and urinary signs and symptoms defined as genitourinary syndrome of menopause (GSM).1-3 Several lasers, including fractional carbon dioxide (FxCO2), erbium:yttrium aluminum garnet (Er:YAG), and hybrid 1470-nm diode, and radiofrequency (RF) devices, are FDA cleared for vaporization, incision, excision, ablation, or photocoagulation of genitourinary tissue. Fractional CO2 (10,600 nm), Er:YAG (2940 nm), and diode (1470 nm) lasers create microcolumns of vaporized or thermally denatured tissue in the vulva and vagina, stimulating histological findings of thickened glycogen-rich epithelium, fibroplasia, neocollagenesis, angiogenesis, and restoration of papillation, which correlate with clinical improvements in GSM signs and symptoms.1-6 An at-home red and infrared light device has been demonstrated in published studies to improve vaginal health on validated scales and indices and may provide practical alternative to in office procedures.7,8 FxCO2 has been shown to improve the signs and symptoms of vulvovaginal atrophy (VVA) and stress urinary incontinence (SUI), however the results begin to wane between 6 and 12 months post-treatment.9,10 A post-menopausal population that completed 12-month follow after a series of FxCO2 vulvovaginal treatments were subsequently treated with an at-home red and infrared LED vaginal device with long-term follow-up to 1 year.

PATIENTS AND METHODS

Patients
10 post-menopausal subjects completing 12-month follow up following three FxCO2 treatments to the vulva and vagina for GSM were enrolled for treatment with an at-home red and infrared
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