Young Grace J, Lewis Amanda L, Lane J Athene, Winton Helen L, Drake Marcus J, Blair Peter S
Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Trials. 2017 Oct 3;18(1):455. doi: 10.1186/s13063-017-2206-y.
Current management for men with lower urinary tract symptoms (LUTS) is a pathway that results in prostate surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care).
METHODS/DESIGN: This analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal.
This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial's objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018.
ISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.
目前对下尿路症状（LUTS）男性患者的治疗方案往往会导致很大比例的患者接受前列腺手术。虽然手术有助于缓解良性前列腺梗阻（BPO），但对于那些存在与BPO无关的排尿困难的男性患者，手术可能无效。“上游”试验于2014年10月开始招募患者，目的是确定一条包含尿动力学检查（一种用于诊断BPO的工具，因此可指示是否需要手术）的护理路径，在症状改善方面，对于男性患者而言，是否并不比不包含尿动力学检查的路径（常规护理）差。
方法/设计：本分析计划概述了该研究的主要结果以及具体的设计选择，如非劣效性界值。该试验目前正在英国的26家医院招募患者，将男性患者随机分为接受尿动力学检查组或常规护理组，招募工作定于2016年12月31日结束。所有结果将在随机分组18个月后进行测量，以便为手术操作和恢复留出足够时间。主要结果基于非劣效性设计，在国际前列腺症状评分（IPSS）量表上的界值为1分。该试验的关键次要结果是每组的手术率，预计接受尿动力学检查组的手术率至少低18%。手术率、不良事件、尿流率、排尿症状和性功能症状是将评估其优越性的次要结果。这是对已发表在本期刊上的“上游”试验方案的更新。
这个预先设定的统计分析计划旨在通过在招募结束前公布试验目的和计划来减少报告偏倚。预计在2018年9月30日试验结束日期后不久将公布试验结果。
ISRCTN注册库，ISRCTN56164274。于2014年4月8日注册。
