Fractional Co 2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy.

BACKGROUND AND OBJECTIVES: More studies are needed to assess the long-term safety profile and clinical outcomes of lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy. This study evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in a postmenopausal population.

STUDY DESIGN/MATERIALS AND METHODS: In this prospective, self-controlled, open-label clinical study, 18 postmenopausal females with atrophic vaginitis received 3 monthly treatments to the vulva and vagina with a fractional CO2 laser system and 1-, 3-, 6-, and 12-month follow-up. Investigators used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. Sexual function at each timepoint was subject-reported, using the validated Female Sexual Function Index (FSFI).

RESULTS: Treatment of the vulva and vagina in postmenopausal women with fractional CO2 laser resurfacing resulted in statistically significant improvements as compared with baseline at all post-treatment and follow-up intervals to 12 months in VHI and FSFI (P ≤ 0.003 and P ≤ 0.03, respectively). Mean total VHI score increased from a baseline of 11.8-22.8 (93.2% improved) at 6-month follow-up (P = 0.0002) slightly decreasing to 21.4 (81.4% improved) at 12-month follow-up post-treatment (P = 0.0003). Mean FSFI Scores increased from a baseline of 17.9-26.3 (46.9% improvement) at 12-month follow-up post-treatment (P ≤ 0.0048). Cohort analysis revealed restoration of normal or near-normal (23-25) VHI following laser treatment in the recently menopausal (1-3 years) greatly exceeded that of the >3 years postmenopausal population and the difference was statistically significant (P ≤ 0.05). Normal/near-normal VHI at 3-, 6-, and 12-month post-treatment was 88%, 88%, and 63% in the recently postmenopausal cohort, as compared with 30%, 40%, and 10% of the >3 years postmenopausal group (P ≤ 0.05). Patient satisfaction following treatment was rated as high at 94% at 12-month follow-up. Safety findings demonstrated no-to-slight discomfort in the majority of subjects and transient erythema and edema, with no adverse events associated with treatment.

CONCLUSION: Fractional CO2 laser treatment of the vulva and vagina resulted in statistically significant improvements in VHI and FSFI compared with baseline in postmenopausal population that were sustained to 12-month follow-up. Restoration of normal VHI was observed in a statistically significant greater percentage in the recently postmenopausal cohort (1-3 years) as compared with postmenopausal cohort of >3 years, suggesting that early intervention is correlated with improved outcomes. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.