Abstract
BACKGROUND: Genitourinary syndrome of menopause (GSM) is a chronic condition that impairs quality of life and sexual function. Fractional CO(2) laser therapy is a non-hormonal option, but large real-world data on symptom trajectories, durability, and ultrasonographic vulvar changes are limited. We evaluated symptom trajectories, responder rates, exposure-outcome associations, and vulvar tissue changes in a clinical cohort. METHODS: We conducted a retrospective observational study at a single clinic in Japan. From 2016 to 2023, 826 women underwent fractional CO₂ vaginal and vulvar laser therapy (2,129 sessions). Symptoms were assessed using VAS (0-10) scores for six domains. Short-term outcomes were evaluated 20-59 days after the first session (n = 327), and long-term outcomes 10-14 months after the final session (n = 94). Responders were defined as a ≥2-point VAS improvement among women with baseline VAS ≥2. OBJECTIVE: outcomes included ultrasonographic labia majora thickness; post-treatment imaging corresponded to the same windows when paired measurements were available. Patient satisfaction and adverse events were recorded. RESULTS: Mean age at first treatment was 61.9 ± 10.2 years (range, 29-87). All six symptoms improved short term, with the largest improvements typically in dyspareunia and vaginal dryness. At 10-14 months, improvements in dryness and urinary leakage attenuated, whereas dyspareunia was most durable. Labia majora thickness increased overall (16.9 ± 4.5-18.9 ± 3.1 mm), with thickening in 81.5% of women with paired measurements. Higher responder rates were observed among women receiving more sessions; however, these findings are associational and may reflect baseline severity and follow-up engagement. Satisfaction was high, and no serious adverse events were observed. CONCLUSIONS: In this real-world cohort, fractional CO(2) vaginal and vulvar laser therapy for GSM was associated with reduced symptom severity and ultrasonographic thickening of the labia majora in a subset with paired measurements. Given the retrospective uncontrolled design, incomplete follow-up, and placebo effects in sham-controlled trials, findings should be interpreted as descriptive associations, not causal effects. Controlled studies are needed to confirm effectiveness, durability, and maintenance strategies.