Treatment for vaginal atrophy using microablative fractional CO2 laser: a randomized double-blinded sham-controlled trial

Objective: The aim of this study was to evaluate the efficacy of vaginal CO2 laser for the treatment of vaginal atrophy compared to the sham procedure. Methods: Between June 2016 and May 2017, postmenopausal women with moderate to severe intensity of any vaginal atrophy symptoms (VAS) were invited to participate in the study. A total of 88 women were randomized to receive treatment with either vaginal CO2 laser or sham procedures every 4 weeks for three sessions. Both the participants and the evaluators were blinded to the treatment. Vaginal Health Index (VHI) score (primary outcome), VAS score, and the item for vaginal dryness from the International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms questionnaire were compared between the two groups by intention-to-treat analysis at 12 weeks after treatment. Results: Eighty-eight women were enrolled into the study and nine women were lost to follow-up. After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved. For VHI and VAS scores the mean difference between the laser group versus the sham group was 1.37 (95% CI: 0.12-2.63), P < 0.001 and -1.52 (95% CI: -2.21 to -0.82), P = 0.03, respectively. Conclusions: This study demonstrated that the application of microablative fractional CO2 laser was effective in treating vaginal atrophy. It could be a promising alternative treatment for postmenopausal women with vaginal atrophy.