Vaginal atrophy treatment using microablative fractional carbon dioxide laser: a randomized patient and evaluator-blinded sham-controlled trial

Abstract

Introduction: In recent years, microablative fractional carbon dioxide (CO2) laser becomes popular in treatment of vaginal symptoms including vaginal atrophy. This study aimed to evaluate efficacy of vaginal CO2 laser in 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 symptoms of vaginal atrophy were invited to the study. A total of 88 women were randomized for treatment with vaginal CO2 laser or sham procedure every 4 weeks for 3 sessions. The participants were blinded to the intervention they received. The operator was also blinded from outcomes of those participants. Vaginal health index (VHI) score, vaginal atrophy symptom (VAS) score and vaginal dryness item of the ICIQ-VS questionnaire were compared between groups at 12-week follow-up based on intention to treat analysis. Results: Eighty-eight women were included and 9 women were lost to follow-up. All outcomes of women who received laser treatment significantly improved over 12 weeks, including VHI (p<0.001), VAS (p<0.001), ICIQ-VS (vaginal dryness item) score (p=0.02). When compared both groups at 12 weeks after procedure with intention-to-treat analysis, VHI and VAS score of laser group significantly improved when compared to the sham group (p<0.001 and <0.001 with mean difference of 1.37 (95% CI: 0.12 to 2.63) and -1.52 (95% CI: -2.21 to -0.82) respectively). Conclusions: This study demonstrated that vaginal microablative fractional CO2 laser was effective in treatment of vaginal atrophy. It could be a promising alternative treatment of postmenopausal women with vaginal atrophy.