Department of Urology, Martini Hospital Groningen, Groningen, The Netherlands.
Department of General Practice and Elderly Medicine, University Medical Center, Groningen, The Netherlands.
Neurourol Urodyn. 2019 Sep;38(7):1958-1965. doi: 10.1002/nau.24099. Epub 2019 Jul 8.
An increasing number of diagnostic and therapeutic medical devices are available to help patients and physicians manage pelvic floor symptoms in women. Many of these are presented at scientific conferences, and in the absence of a gold standard for evaluation, marketing has become more prominent than scientific evaluation. The goal of this study was to (a) provide an overview of pelvic floor devices for women that have been presented at recent annual meetings of leading scientific societies and (b) to summarize and review the scientific evidence underpinning these devices.
Manual searches were performed of all abstracts presented in 2016 and 2017 at annual meetings of the International Continence Society, the International Urogynecological Association, the European Association of Urology, and the American Urological Association. The exhibition floor of the 2017 International Continence Society was also searched. Subsequently, literature searches of both the MEDLINE and Embase databases were performed in November 2018 to identify original full-text publications related to the identified devices.
We identified 11 devices from these sources, which were mainly used for the control of urinary incontinence. Only seven of these pelvic floor devices were covered by publications, with no full-text records identified for the remaining four devices.
Sample sizes were small and there was a lack of convincing evidence for most devices. Despite this, many devices were available in the market. Our findings indicate that the process for introducing these new devices is in stark contrast with the strict requirements for introducing new drug classes.
越来越多的诊断和治疗医疗器械可用于帮助患者和医生管理女性盆底症状。其中许多产品在科学会议上展示，由于缺乏评估的金标准，营销变得比科学评估更为突出。本研究的目的是：(a) 提供在最近举行的领先科学协会年会上展示的女性盆底设备的概述；(b) 总结和回顾这些设备的科学证据。
对 2016 年和 2017 年国际尿控协会、国际妇科泌尿协会、欧洲泌尿外科学会和美国泌尿外科学会年会上所有摘要进行了手动检索。还对 2017 年国际尿控协会的展览场地进行了搜索。随后，于 2018 年 11 月对 MEDLINE 和 Embase 数据库进行了文献检索，以确定与已确定设备相关的原始全文出版物。
我们从这些来源中确定了 11 种设备，这些设备主要用于控制尿失禁。这 11 种盆底设备中只有 7 种被相关出版物报道，其余 4 种设备没有找到完整的文本记录。
样本量较小，大多数设备缺乏令人信服的证据。尽管如此，许多设备已经在市场上推出。我们的研究结果表明，引入这些新设备的过程与引入新药物类别的严格要求形成鲜明对比。
