Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Health Technol Assess. 2020 Sep;24(42):1-122. doi: 10.3310/hta24420.
Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery.
The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome.
This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research.
Urology departments of 26 NHS hospitals in England.
Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised.
Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm).
The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness.
A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS.
The trial met its predefined recruitment target, but surgery rates were lower than anticipated.
Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS.
Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy.
Current Controlled Trials ISRCTN56164274.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.
男性下尿路症状（LUTS）可能表明存在膀胱出口梗阻（BOO）或逼尿肌功能障碍（DU）。严重的令人困扰的 LUTS 是手术的常见指征。诊断测试可能包括尿动力学（UDS）以确认 BOO 或 DU 是否是病因，这可能会减少接受（不适当）手术的人数。
主要目的是确定包括 UDS 的护理路径在随机分组后 18 个月时对症状结果是否不比不包括 UDS 的路径差。手术率是关键次要结局。
这是一项实用的、多中心、两臂（非盲）随机对照试验，结合了健康经济学分析和定性研究。
英格兰 26 家 NHS 医院的泌尿科。
寻求进一步治疗（可能包括手术）的因有症状 LUTS 而感到困扰的男性（年龄≥18 岁）。排除标准如下：无法无导管排尿、患有相关神经疾病、正在接受前列腺或膀胱癌治疗、之前接受过前列腺手术、不适合手术和/或不愿意接受随机分组。
男性被随机分配到基于非侵入性常规检查的护理路径（对照组）或常规护理加侵入性 UDS（干预组）。
主要结局是随机分组后 18 个月时的国际前列腺症状评分（IPSS），关键次要结局是手术率。其他次要结局包括不良事件（AE）、生活质量、尿和性功能症状、UDS 满意度、最大尿流率和成本效益。
共有 820 名男性被随机分配（UDS，427；常规护理，393）。67 名男性在 18 个月前退出，11 名男性死亡（与试验程序无关）。UDS 在随机分组后 18 个月时与常规护理相比非劣效，置信区间（CI）在 1 分的范围内（-0.33，95%CI -1.47 至 0.80）。未发现 UDS 组的手术率较低（UDS 组和常规护理组分别为 38%和 36%），总体率低于预期。两组之间的 AE 相似（43-44%）。常规护理组中更常见急性尿潴留病例。两组的 LUTS 患者报告结局均有所改善，接受 UDS 的男性对其满意度较高。UDS 比常规护理更昂贵。从二级护理的角度来看，UDS 在 18 个月的时间内增加了 216 英镑的成本。质量调整生命年（QALY）相似，UDS 在 18 个月内具有 0.006 的优势。确定 UDS 被患者接受，并被患者和临床医生重视，因为它对 LUTS 的病因和可能的最佳治疗有额外的了解。
该试验达到了预定的招募目标，但手术率低于预期。
在诊断测试中纳入 UDS 可导致与常规护理路径相当的症状结果，但不会影响治疗 BOO 的手术率。结果不支持在接受 LUTS 检查的男性中常规使用 UDS。
应关注在个别情况下选择性使用 UDS 的指征以及诊断和治疗的长期结果。
当前对照试验 ISRCTN56164274。
该项目由英国国家卫生研究院（NIHR）健康技术评估计划资助，将在 ; 第 24 卷，第 42 期全文发表。请访问 NIHR 期刊库网站以获取更多项目信息。
