Urology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria, Madrid, Spain.
Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.
J Sex Med. 2020 May;17(5):841-848. doi: 10.1016/j.jsxm.2020.02.013. Epub 2020 Mar 20.
Laser-based technologies have been commercially marketed as "wonder treatments" without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal "rejuvenation" or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function.
To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence.
A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients.
Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed.
Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications.
Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established.
STRENGTHS & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice.
It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.
基于激光的技术已作为“神奇疗法”推向市场，但缺乏充分和适当的证据支持。此外，美国食品和药物管理局于 2018 年 7 月 30 日发布了一则关于使用基于激光的设备的安全性警告，涉及以下适应症：阴道“年轻化”或美容阴道手术、与绝经相关的阴道状况和症状、尿失禁和性功能。
对可用于治疗女性泌尿生殖系统疾病的基于激光的阴道设备的现有文献进行全面审查，并根据证据水平将结果总结为几个简短的陈述。
根据多个数据库对妇科疾病的激光治疗文献进行了全面综述。符合条件的研究包括至少 15 名患者。
已经研究了几个方面，包括临床前数据。对涵盖的每个主题，都对基于激光的设备的数据进行了分析。
尽管研究存在高度异质性及其局限性，但委员会就基于激光的设备在泌尿生殖系统疾病中的应用发布了几项声明。
临床环境中的现有数据仍然较差，这些技术对阴道症状和体征的影响尚未明确确立。
所有研究均由专家组进行评估，为临床实践提供建议。
基于激光的设备的发展和研究还处于早期阶段，无法就阴道治疗做出决定性建议。出于安全原因、可能的危害以及不同研究适应症的短期/长期获益，迫切需要开展设计合理的随机对照试验。
