Directorate of Women's Services, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
Trials. 2011 Jul 6;12:169. doi: 10.1186/1745-6215-12-169.
Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness.
METHODS/DESIGN: This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions.
The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim.
Current Controlled Trials ISRCTN71327395 assigned 7th June 2010.
尿失禁对患者个人和医疗服务机构而言都是一个重要的健康问题。由于手术技术的进步，压力性和以压力为主的混合性尿失禁越来越多地通过手术来治疗。尽管缺乏其临床应用的证据，但大多数临床医生在为这种疾病提供手术治疗之前，会通过侵入性尿动力学测试（IUT）来确认尿动力学压力性尿失禁的功能诊断。IUT 既昂贵又令女性感到尴尬和不适，而且存在一定的风险。最近的系统评价证实了缺乏高质量的有效性证据。本研究旨在测试未来确定性随机对照试验的可行性，该试验将解决 IUT 是否会改变这些女性的治疗决策和治疗结果，并测试其临床和成本效益。
方法/设计：这是一项混合方法实用多中心可行性先导研究，包括四个部分：（a）一项多中心外部先导随机试验，比较基本临床评估与非侵入性测试和 IUT。主要结局指标是招募率、随机分组率和数据完成率。数据将用于估计确定性试验所需的样本量。（b）对符合试验条件的女性进行有针对性的亚组定性访谈，以探讨其参与、随机分组和总体试验体验的意愿。（c）对临床医生进行全国性调查，以确定他们在这种情况下对 IUT 的看法，主要结局是他们是否愿意将患者随机分配到确定性试验中。（d）对这些临床医生进行有针对性的小组定性访谈，以探讨他们是否以及如何使用 IUT 来为其决策提供信息。
先导试验将提供可行性和可接受性的证据，从而为是否进行确定性试验做出决策。结果将为确定性试验的设计和实施提供信息，并确保其在实现研究目标方面的有效性。
当前对照试验 ISRCTN71327395 于 2010 年 6 月 7 日注册。
