Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
Adv Ther. 2024 Dec;41(12):4617-4627. doi: 10.1007/s12325-024-03004-7. Epub 2024 Oct 29.
This study evaluates the efficacy and safety of non-ablative diode laser therapy for genitourinary syndrome of menopause (GSM) in post-menopausal women unable to use hormonal therapies.
A pilot prospective study was conducted from September 2023 to April 2024, involving 22 post-menopausal women aged 45-73 years. Participants underwent three sessions of diode laser treatment with the Leonardo dual-wavelength Diode laser. Assessments were made at baseline, 3 months, and 6 months post-treatment. Main outcome measures included Visual Analog Scale (VAS) scores for GSM symptoms, Vaginal Health Index Score (VHIS), and sexual function evaluated using the Female Sexual Function Index (FSFI-6), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Sexual Quality of Life-Female (SQOL-F) questionnaire.
Significant improvements were observed in VHIS, increasing from 12 to 19.27 at 6 months (p < 0.001). GSM symptoms improved significantly: vaginal dryness scores decreased from 7.72 ± 2.37 to 3.72 ± 2.53, burning sensation scores dropped from 6.00 ± 3.22 to 1.90 ± 1.81, and dyspareunia scores reduced from 8.09 ± 2.11 to 3.90 ± 2.58 (all p < 0.016). Sexual function improved, indicated by FSFI-6 scores increasing from 12.27 ± 7.29 to 19.30 ± 6.24 (p < 0.016) and SQOL-F scores rising from 63.18 ± 22.93 to 71.45 ± 23.31. No adverse events were reported.
Non-ablative diode laser therapy is effective and safe for managing GSM symptoms in post-menopausal women, offering significant symptom relief and enhancing sexual health without serious side effects. Further research with a larger cohort and extended follow-up is needed to confirm these findings.
Clinical Trials ID NCT06503003.
本研究评估了非剥脱性二极管激光治疗绝经后妇女（年龄 45-73 岁）无法使用激素疗法的女性生殖泌尿系统综合征（GSM）的疗效和安全性。
一项前瞻性试点研究于 2023 年 9 月至 2024 年 4 月进行，共纳入 22 名绝经后妇女。参与者接受了三次二极管激光治疗，使用 Leonardo 双波长二极管激光。在基线、3 个月和 6 个月时进行评估。主要结局指标包括 GSM 症状的视觉模拟量表（VAS）评分、阴道健康指数评分（VHIS）、使用女性性功能指数（FSFI-6）评估的性功能、盆腔器官脱垂/尿失禁性功能问卷（PISQ-12）和女性性健康生活质量问卷（SQOL-F）。
VHIS 显著改善，6 个月时从 12 分增加到 19.27 分（p<0.001）。GSM 症状显著改善：阴道干燥评分从 7.72±2.37 降至 3.72±2.53，烧灼感评分从 6.00±3.22 降至 1.90±1.81，性交痛评分从 8.09±2.11 降至 3.90±2.58（均 p<0.016）。性功能改善，FSFI-6 评分从 12.27±7.29 增加到 19.30±6.24（p<0.016），SQOL-F 评分从 63.18±22.93 增加到 71.45±23.31。未报告不良事件。
非剥脱性二极管激光治疗对绝经后妇女 GSM 症状有效且安全，可显著缓解症状，改善性健康，无严重副作用。需要更大队列和更长随访时间的进一步研究来证实这些发现。
临床试验 ID NCT06503003。
