Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: a prospective observational study

Objectives: To evaluate the safety of and patient satisfaction with fractional CO2 laser for the treatment of vulvo-vaginal atrophy (VVA) in postmenopausal patients. Study design: Patients affected by VVA were considered for the study. All women were treated using a Lumenis AcuPulse DUO (Lumenis, Yokneam, Israel) in fractionated mode with a 28 mm probe, FemTouch™. Pain during different steps of the procedure (introduction, rotation and extraction of probe and laser impulse transmission) was evaluated on a 7-point Likert scale. The occurrence of side-effects was evaluated at the end of the procedure, and in the three-month follow-up (after the last treatment) complications were classified as ‘early’ (occurring within 30 days) or late (after 30 days). Participant satisfaction was measured on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). The institutional review board approved the study protocol. Results: Fifty-three women were enrolled in the study. No severe complications occurred after a median follow-up of six months. One patient (1.9 %) reported dizziness immediately after treatment, which completely resolved within 15 min. A minor bleeding occurred related to tip introduction and rotation. One patient (1.9 %) aborted the procedure because of discomfort on probe introduction but decided to repeat the procedure after two weeks. Two patients (3.7 %) reported symptoms of dysuria within 7 days of the procedure. The mean overall pain score at first treatment, evaluated on the 7-point Likert scale, was 3.57 ± 1.50. The mean pain scores related to probe introduction and rotation were 3.13 ± 1.37 and 2.32 ± 1.08, whereas pain scores for extraction and laser impulse transmission were 1.23 ± 0.27 and 1.13 ± 0.37 respectively. Mean overall pain score (1.27; CI 95 % 0.83–1.71, p < 0.001) and pain scores related to probe introduction (0.54; CI 95 % 0.18–0.90, p = 0.001) and probe rotation (0.46; CI 95 % 0.12–0.90, p = 0.003) all statistically significantly decreased between the first and third treatment (Fig. 1). Mean pain scores related to laser activation (0.01; CI 95 % −0.06 – 0.20, p = 0.07) and extraction (0.08; CI 95 % −0.04–0.19, p = 0.31) did not change over the course of treatment. Overall, patient satisfaction with the procedure was high: 89.7 % of patients would highly (value 5–7) recommend the procedure and 94.9 % would be ready to repeat the procedure to maintain results. Discomfort related to treatment was lower than expected for 41 % of patients (value 5–7) and as expected for 48.7 % (value 3–4). Conclusion: Fractional CO2 laser for treatment of VVA seems a safe therapeutic option. No severe complications occurred. A minority of patients reported mild complications, but these resolved without the need for treatment. Most discomfort was related to probe introduction and rotation. Overall, patients were highly satisfied, and they would repeat laser treatment