A Randomized, Placebo-Controlled Trial Evaluating the Single and Combined Efficacy of Radiofrequency and Hybrid Fractional Laser for Nonsurgical Aesthetic Genital Procedures in Post-Menopausal Women
Christine E Wamsley, Mikaela Kislevitz, Nicole R Vingan, Sydney Oesch, Karen B. Lu, Jennifer Barillas, John Hoopman, Yucel Akgul, Deniz Basci, Kimberly A. Kho, P. Zimmern, Jeffrey M. Kenkel
Abstract
BACKGROUND: The efficacy of interventions that provide long-term relief of genitourinary symptoms of menopause has not been determined. OBJECTIVES: The authors sought to evaluate radiofrequency and hybrid fractional laser (HFL) treatments for menopausal vulvovaginal symptoms. METHODS: Thirty-one postmenopausal women completed all treatments and at least 1 follow-up. Outcomes included the Vulvovaginal Symptom Questionnaire (VSQ), Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form, Incontinence Impact Questionnaire (IIQ), Female Sexual Function Index (FSFI), laxity measurements via a vaginal biometric analyzer probe, and gene expression studies. RESULTS: Mean VSQ score decreased 2.93 (P = 0.0162), 4.07 (P = 0.0035), and 4.78 (P = 0.0089) among placebo, dual, and HFL groups 3 months posttreatment and decreased to 3.3 (P = 0.0215) for dual patients at 6 months. FSFI scores increased in the desire domain for placebo and dual groups and in arousal, lubrication, orgasm, satisfaction, and pain domains for the HFL group 3 and 6 months posttreatment. An increase of 1.14 in VLQ score (P = 0.0294) was noted 3 months and 2.2 (P = 0.002) 6 months following dual treatment. There was also a mean decrease of 15.3 (P = 0.0069) in IIQ score for HFL patients at 3 months. Dual, HFL, and RF treatments resulted in statistically significant decreases in collagen I, elastin, and lysyl oxidase expression. CONCLUSIONS: Several self-reported improvements were noted, particularly among HFL, dual, and placebo groups 3 and 6 months posttreatment. Objective biopsy analysis illustrated decreased gene expression, suggesting that treatments did not stimulate new extracellular matrix production.