Women with Genitourinary Syndrome of Menopause Treated with Vaginal Estriol, Microablative Fractional CO2 Laser and Microablative Fractional Radiofrequency: A Randomized Pilot Study.

Abstract

Objective: This pilot study intended to assess the feasibility of a large-scale randomized clinical trial designed to analyze the effectiveness of microablative fractional CO₂ laser (CO₂L) and microablative fractional radiofrequency (RF) compared with vaginal estriol (VE) as treatments for women with moderate-to-severe Genitourinary Syndrome of Menopause (GSM). Methods: Participants were randomized into VE, CO₂L, or RF groups. In the VE group, women were required to use vaginal estriol cream for 14 days and then twice a week for 4 months. In the CO₂L and RF groups, three energy therapies were administered at monthly intervals. Visual Analog Scale (VAS) for GSM symptoms, Female Sexual Function Index (FSF-I), Vaginal Health Index (VHI), and Nugent Score (NS) were analyzed before and 120 days after the beginning of the treatments. Pain scores were verified after each CO₂L and RF session. Results: Thirty-four participants completed the study: 11 in the VE group, 11 in the CO₂L group, and 12 in the RF group. No unexpected or serious adverse events were observed. We also verified that GSM symptoms, sexual function, and VHI significantly improved (p < 0.05) with no difference among the groups. NS did not show statistically significant difference before and after the treatments. Pain during RF application was associated with higher scores. Conclusions: The study is feasible and does not seem to have safety implications. Preliminary results suggest that CO₂L and RF are good alternatives to VE for ameliorating clinical symptoms, FSF-I, and VHI in patients with GSM. Clinical Trial Registration number: NCT04045379.