Department of Urology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Heaton, Newcastle, UK.
Department of Urology, UMC, Utrecht, Netherlands.
Neurourol Urodyn. 2018 Jun;37(S4):S32-S37. doi: 10.1002/nau.23561.
In recent years urodynamic innovations, although well researched, have failed to follow a standardized development pathway specifically in terms of clinical trials undertaken to demonstrate efficacy. This was discussed at the International Consultation on Incontinence Research Society (ICI-RS) in Bristol, United Kingdom, 2017 with the aim of defining minimum standards for future urodynamic research.
The recent recommendations from the IDEAL (innovation, development, exploration, assessment, and long-term study) collaboration regarding surgical research were reviewed. Two examples of recent novel urodynamic technologies, the penile cuff test and air charged urodynamic catheters were used as case studies and the research programmes behind their development were critiqued.
The rigorous and standardized model of surgical research proposed by the IDEAL collaboration was endorsed as an appropriate model for future urodynamic research. A methodical approach to research can fulfil a host of objectives including illustration of the clinical need, help with design and refinement of technique and proving efficacy for any new test or device. The penile cuff test is a novel urodynamic measurement technique that has been well researched and is now used in clinical practice. Further research is needed before air charged catheters can be recommended for widespread clinical use and the IDEAL framework provides a template for ongoing development.
In the future, these recommendations should lead to a more standardized and uniform programme of urodynamic research and enable a thorough evaluation of new technologies prior to wider clinical uptake.
近年来,尽管尿动力学领域的创新研究进展良好,但在临床试验方面,尚未遵循标准化的发展路径来证明其疗效。这一问题在 2017 年于英国布里斯托尔举行的国际尿控协会(ICI-RS)会议上进行了讨论,旨在为未来的尿动力学研究定义最低标准。
本文回顾了 IDEAL(创新、开发、探索、评估和长期研究)协作组织提出的外科研究建议。本文将阴茎套囊测试和充气式尿动力学导管这两种新型尿动力学技术作为案例研究,并对其开发背后的研究计划进行了批判性评估。
IDEAL 协作组织提出的严格且标准化的外科研究模型得到了认可,认为该模型适用于未来的尿动力学研究。有针对性的研究方法可以实现诸多目标,包括说明临床需求、帮助设计和改进技术,并为任何新的测试或设备提供疗效证据。阴茎套囊测试是一种新的尿动力学测量技术,已得到充分研究,并已在临床实践中应用。在推荐充气式导管广泛用于临床应用之前,还需要进一步的研究,而 IDEAL 框架为进一步开发提供了模板。
未来,这些建议应能促成更标准化和统一的尿动力学研究计划,并在更广泛的临床应用之前对新技术进行全面评估。