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

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.

Fractional CO2 Laser, Radiofrequency and Topical Estrogen for Treating Genitourinary Syndrome of Menopause: A Pilot Study Evaluating the Vulvar Vestibule.

Background and Objectives: Genitourinary syndrome of menopause (GSM) affects more than half of postmenopausal women. This study aimed to evaluate the clinical and histological aspects of microablative fractionated CO2 laser (CO2L), microablative fractionated radiofrequency (RF) and intravaginal estrogen (ET) therapy as GSM treatments for the vulvar vestibule. Materials and Methods: This study included postmenopausal women with at least one moderate-to-severe complaint of GSM. Women in the CO2L and RF groups received three monthly sessions of outpatient vulvovaginal therapy. The procedures were performed 30 min after applying 4% lidocaine gel to the vulva and vaginal introitus. Vulvar vestibular pain was assessed after each application using a 10-point VAS. A follow-up evaluation was performed 120 days after beginning each treatment. Digital images of the vulva were obtained and a 5-point Likert scale (1 = much worse, 2 = worse, 3 = neutral, 4 = better, 5 = much better) was used to assess the global post-treatment women's impression of improvement regarding GSM. Results: A significant change in clinical aspects of the vulva was observed after all treatments with a reduction in the atrophic global vulvar aspect and an enhancement of the trophic aspect. High satisfaction was also reported after treatment according to the Likert scale evaluation: CO2L (4.55 ± 0.97), RF (4.54 ± 0.95), CT (4 ± 1.41), p = 0.066. Histological evaluation revealed enhanced dermal papillae before pre-treatment, significantly reducing post-treatment in all groups (p = 0.002). No unintended effects were reported. Conclusions: CO2L, RF, and ET significantly improved GSM concerning the vulvar vestibule at the 4 months follow-up.