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

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 114 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.

Automated summary

This study evaluated the efficacy of radiofrequency and hybrid fractional laser (HFL) treatments for menopausal vulvovaginal symptoms. The results showed significant improvements in HFL, dual, and placebo groups at 3 and 6 months posttreatment. Objective biopsy analysis indicated that the treatments did not stimulate new extracellular matrix production.