Long-term safety and efficacy of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy

Background and Aim: We have previously reported improvement of clinical symptoms of genitourinary syndrome of menopause (GSM) at 3 and 6 months following three CO₂ laser treatments. The current paper presents the results of long term follow up at 12, 15- and 18-months post laser treatment. Methods: Twenty subjects (mean age 60.65 ± 6.34 years) who had completed the core study participated in follow-up. Subjects were evaluated at 12, 15, and 18 months following final laser therapy. An optional maintenance treatment was offered during Month 12 and Month 15 to those women who failed to increase their Vaginal Health Index Score (VHIS) by more than 34% from their individual baseline, or if the subject desired an additional treatment. At each study visit, VHIS and vulvovaginal atrophy (VVA) symptom severity were recorded. Sexual function was assessed using the Female Sexual Function Index (FSFI). Results: Fifteen subjects were eligible for a single maintenance treatment (N = 2, at 12 months, and N = 13 at 15 Months). The mean VHIS (± standard deviation) remained significantly improved at 12 months following their last laser treatment (16.3 ± 4.5 vs. Baseline 12.4 ± 4.0; p < 0.05) and at the 15- and 18-months follow up visits as well (16.9 ± 4.6 and 17.1 ± 4.6, respectively; p < 0.05 compared to Baseline). Almost all VVA symptoms were significantly improved at 12 months following the third treatment compared to Baseline and this improvement was sustained at 15 and 18 months. At the 12 Months visit, the total FSFI score increased significantly (N = 15, 24.4 ± 6.9; p < 0.05), and at the 15- and 18-month follow- up visits, the total FSFI remained significantly higher than Baseline (22.2 ± 6.7, 25.8 ± 6.6). Conclusion: Fractional CO₂ laser treatments are effective in alleviating symptoms of VVA and sexual dysfunction in post-menopausal women, and that effects are sustained over the long-term.