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.

中文翻译：

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CO2 点阵激光治疗阴道萎缩绝经后妇女的安全性评价：一项前瞻性观察研究

目的 评估点阵 CO2 激光治疗绝经后患者外阴阴道萎缩 (VVA) 的安全性和患者满意度。研究设计 本研究考虑了受 VVA 影响的患者。所有女性均使用 Lumenis AcuPulse DUO（Lumenis，Yokneam，Israel）和 28 毫米探针 FemTouch™ 以分次模式进行治疗。在 7 点李克特量表上评估手术不同步骤（探头的引入、旋转和提取以及激光脉冲传输）期间的疼痛。在手术结束时评估副作用的发生，并在三个月的随访中（最后一次治疗后）将并发症分类为“早期”（30 天内发生）或晚期（30 天后） . 参与者满意度采用 7 点李克特量表（1= 非常不同意，7=强烈同意）。机构审查委员会批准了研究方案。结果 53 名女性参加了这项研究。中位随访 6 个月后未发生严重并发症。一名患者 (1.9%) 在治疗后立即报告头晕，并在 15 分钟内完全消失。发生与尖端引入和旋转相关的轻微出血。一名患者 (1.9 %) 由于探头引入不适而中止手术，但决定在两周后重复手术。两名患者 (3.7%) 在手术后 7 天内报告了排尿困难的症状。第一次治疗时的平均总疼痛评分，根据李克特 7 点量表进行评估，为 3.57 ± 1.50。与探头引入和旋转相关的平均疼痛评分分别为 3.13 ± 1.37 和 2.32 ± 1.08，而拔牙和激光脉冲传输的疼痛评分分别为 1.23 ± 0.27 和 1.13 ± 0.37。平均总体疼痛评分 (1.27；CI 95 % 0.83-1.71，p < 0.001) 和与探头引入相关的疼痛评分 (0.54；CI 95 % 0.18-0.90，p = 0.001) 和探头旋转 (0.46；CI 95 % 0.12-) 0.90，p = 0.003）在第一次和第三次治疗之间均显着降低（图 1）。与激光激活（0.01；CI 95 % -0.06 - 0.20，p = 0.07）和拔牙（0.08；CI 95 % -0.04-0.19，p = 0.31）相关的平均疼痛评分在治疗过程中没有变化。总体而言，患者对手术的满意度很高：89.7% 的患者会高度推荐（值 5-7），94.9% 的患者准备重复手术以保持结果。41% 的患者（值 5-7）和预期的 48.7%（值 3-4）患者的治疗相关不适低于预期。结论 点阵 CO2 激光治疗 VVA 似乎是一种安全的治疗选择。没有发生严重的并发症。少数患者报告了轻度并发症，但这些并发症无需治疗即可解决。大多数不适与探头引入和旋转有关。总体而言，患者非常满意，他们会重复激光治疗。