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非剥脱性双波长二极管激光治疗男性绝经后泌尿生殖系统综合征的疗效和安全性:一项单中心前瞻性研究。

Efficacy and Safety of Non-Ablative Dual Wavelength Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Single-Center Prospective Study.

机构信息

Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.

出版信息

Adv Ther. 2024 Dec;41(12):4617-4627. doi: 10.1007/s12325-024-03004-7. Epub 2024 Oct 29.

Abstract

INTRODUCTION

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

TRIAL REGISTRATION

Clinical Trials ID NCT06503003.

摘要

简介

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。

方法

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)。

结果

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。

结论

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。

试验注册

临床试验 ID NCT06503003。

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