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.
目的:这篇共识文章旨在对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最终导致了泌尿生殖系统应用技术的方案开发,并在未来的临床试验中开发一致的参数。
方法:已发表的关于激光和基于能量的装置应用于泌尿生殖系统疾病的文章和临床试验数据根据装置和条件进行分类,并就方案和参数达成共识。
结果:泌尿生殖系统中的设备被归类为分数激光,射频和高强度聚焦电磁场治疗。根据已发表的临床试验将方案和参数应用于与更年期泌尿生殖系统综合征相关的阴道和泌尿系统疾病,根据设备和条件制定和组织了共识。
结论:讨论了FDA许可的现状和未来的途径。
结论:本共识文章对未来临床试验中用于泌尿生殖系统的主要激光和基于能量的设备分类并提出了方案和实践。