School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
BJU Int. 2018 May;121(5):805-810. doi: 10.1111/bju.14121. Epub 2018 Jan 30.
To review measures used in recent randomised controlled trials (RCTs) evaluating stress urinary incontinence (SUI) treatments and to propose the most relevant outcome measure that should be included in future trials.
We identified RCTs for SUI interventions published between January 2015 and July 2017. We listed the objective and subjective outcome measures used in eligible trials in the literature search. Using data from our RCT conducted from 2013 to 2016 evaluating pulsed magnetic stimulation for SUI, we analysed the correlation between all measures.
A total of 45 RCTs were included; 28 (62%) involved surgical interventions. The most frequently used objective and subjective measures were the cough stress test and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), respectively. In all, 24 different validated questionnaires were administered in the 42 studies that used subjective outcome measure. Analyses of measures used in our trial showed that all measures were significantly correlated with each other except for pelvic floor muscle function. The ICIQ-UI SF showed the highest correlation coefficients (0.587-0.733) with all outcome measures.
The outcome measures used in recent trials were inconsistent. The ICIQ-UI SF had the highest correlation with all measures in our trial; however, further studies evaluating correlation of measures in other patient cohorts are needed to corroborate our present results. We propose the use of ICIQ-UI SF, as the most relevant outcome measure, in future trials evaluating efficacy of SUI interventions.
回顾近期评估压力性尿失禁（SUI）治疗的随机对照试验（RCT）中使用的措施，并提出应纳入未来试验的最相关的结局测量指标。
我们确定了 2015 年 1 月至 2017 年 7 月发表的 SUI 干预措施的 RCT。我们在文献检索中列出了合格试验中使用的客观和主观结局测量指标。使用我们 2013 年至 2016 年进行的评估脉冲磁场刺激治疗 SUI 的 RCT 的数据，我们分析了所有指标之间的相关性。
共纳入 45 项 RCT，其中 28 项（62%）为手术干预。最常用的客观和主观指标分别为咳嗽压力试验和国际尿失禁咨询问卷-尿失禁简短问卷（ICIQ-UI SF）。在使用主观结局测量指标的 42 项研究中，共使用了 24 种不同的经过验证的问卷。对我们试验中使用的指标进行分析显示，除了盆底肌肉功能外，所有指标之间均存在显著相关性。ICIQ-UI SF 与所有结局测量指标的相关性系数最高（0.587-0.733）。
近期试验中使用的结局测量指标不一致。ICIQ-UI SF 与我们试验中的所有指标相关性最高；然而，需要进一步研究评估其他患者队列中测量指标的相关性，以证实我们目前的结果。我们建议在未来评估 SUI 干预疗效的试验中使用 ICIQ-UI SF 作为最相关的结局测量指标。
