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

Abstract Background The efficacy of interventions that provide long-term relief of genitourinary symptoms of menopause (GSM) has yet to be determined. Objectives To evaluate the efficacy of radiofrequency (RF) and hybrid fractional laser (HFL) treatments for management of menopausal vulvovaginal symptoms. Methods 31 post-menopausal women completed all treatments and at least one follow-up. Outcomes included the Vulvovaginal Symptom Questionnaire (VSQ), Vaginal Laxity Questionnaire (VLQ), laxity measurements via a vaginal biometric analyzer probe, the Urogenital Distress Short Form (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Female Sexual Function Index (FSFI), 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 three months post-treatment and remained decreased by 3.3 (p=0.0215) at six months for dual subjects. 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 three- and six-months post treatment. An average increase in VLQ score of 1.14 (p=0.0294) was noted at three months and 2.2 (p=0.002) at six months following dual treatment. There was also a mean decrease of 15.3 (p=0.0069) in IIQ-7 score for HFL subjects at three months. Dual, HFL and RF treatments resulted in statistically significant decreases in collagen I, elastin, and lysyl oxidase gene expression. Conclusions Several self-reported improvements were noted, particularly among HFL, dual and placebo groups at three and six-months post-treatment. Interestingly, objective biopsy analysis illustrated decreased gene expression, suggesting that treatments did not stimulate new extracellular matrix production.