Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.
Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.
Trials. 2020 Jun 4;21(1):479. doi: 10.1186/s13063-020-04326-x.
Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones.
The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation.
The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.
ISRCTN: ISRCTN98970319. Registered on 11 November 2015.
肾结石很常见，成年人一生中的患病率为 10%。由于肥胖症和糖尿病的发病率上升，全球发病率正在上升，这些患者群体更有可能患上肾结石病。结石引起的侧腹痛（肾绞痛）是英国泌尿科部门急诊入院的最常见原因。结石最常发生在肾脏的下极（约 35%的病例），在这里不经干预最不可能通过。目前，英国国民保健制度中有三种技术可用于去除下极肾结石：体外冲击波碎石术（ESWL）、经皮肾镜碎石术（PCNL）和输尿管软镜碎石术（FURS）联合激光碎石术。目前的证据表明，在下极结石的治疗方面存在不确定性，每种治疗方法都有其优点和缺点。本试验旨在确定 FURS 与 ESWL 或 PCNL 治疗下极肾结石的临床和成本效益。
PURE（PCNL、FURS 和 ESWL 治疗下极肾结石）试验是一项多中心、随机对照试验（RCT），评估 FURS 与 ESWL 或 PCNL 在下极肾结石中的治疗效果。年龄≥16 岁的患者，通过非增强 CT 尿路成像（CTKUB）证实单侧或双侧肾脏的下极有结石，且需要治疗的结石直径≤10mm，将被随机分配接受 FURS 或 ESWL（RCT1），需要治疗的结石直径>10mm 且≤25mm 的患者将被随机分配接受 FURS 或 PCNL（RCT2）。参与者将在干预后 12 周内每周通过问卷调查进行随访，并在随机分组后 12 个月进行随访。主要临床结局是通过多次测量欧洲五维健康量表 5 级版（EQ-5D-5L）问卷计算的曲线下面积来衡量的健康状况，随访时间截至干预后 12 周。主要经济结局是随机分组后 12 个月时每获得一个质量调整生命年的增量成本。
PURE 试验旨在提供关于健康状况、生活质量、临床结果和资源利用的有力证据，直接为三种治疗选择的选择和国家卫生服务提供提供信息。
ISRCTN：ISRCTN98970319。于 2015 年 11 月 11 日注册。
