Dermatology & Laser Surgery Center of New York, New York, New York, USA.
Yale University School of Medicine, New Haven, Connecticut, USA.
Lasers Surg Med. 2023 Jul;55(5):444-454. doi: 10.1002/lsm.23672. Epub 2023 May 2.
Lasers and energy-based technologies have been developed for genitourinary applications over the past several decades.
This consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials.
The published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters.
The devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition.
The status of FDA clearances and future pathways are discussed.
This consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.
过去几十年来,激光和基于能量的技术已经被开发用于治疗泌尿生殖系统疾病。
本文旨在对已发表的文章和临床试验数据进行分类,这些文章和临床试验数据促成了泌尿生殖系统应用技术的方案制定,并为未来的临床试验制定一致的参数。
根据设备和疾病对激光和基于能量的设备应用于泌尿生殖系统疾病的已发表文章和临床试验数据进行分类,并就方案和参数达成共识。
泌尿生殖系统应用的设备分为分激光、射频和高强度聚焦电磁场治疗。根据其应用于与女性绝经相关的泌尿生殖系统综合征的阴道和泌尿科疾病的临床试验的结果,制定了并根据设备和疾病对基于共识的方案和参数进行了组织。
讨论了 FDA 批准的现状和未来的途径。
本文对泌尿生殖系统应用的主要类型的激光和基于能量的设备的方案和实践进行了分类,并在未来的临床试验中进行了介绍。