Wiseman Oliver, Smith Daron, Starr Kathryn, Aucott Lorna, Hernández Rodolfo, Thomas Ruth, MacLennan Steven, Clark Charles Terry, MacLennan Graeme, McRae Dawn, Bell Victoria, Cotton Seonaidh, Gall Zara, Turney Ben, McClinton Sam
Department of Urology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK.
Stone and Endourology Unit, University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.
Eur Urol. 2025 Apr 22. doi: 10.1016/j.eururo.2025.02.002.
The European Association of Urology guidelines recommend that extracorporeal shockwave lithotripsy (ESWL) and flexible ureterorenoscopy (FURS) are equally appropriate first-line treatment options for lower pole renal stones (LPSs). We report a pragmatic multicentre, open-label, superiority randomised controlled trial (RCT) comparing FURS versus ESWL for quality of life, and clinical and cost effectiveness for LPSs of ≤10 mm-one of two RCTs that were part of the Percutaneous nephrolithotomy, flexible Ureteroscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone study (PUrE), with the other PUrE RCT 2 investigating larger stones.
In total, 231 and 230 patients were randomised to FURS and ESWL, respectively. The primary outcome was health status area under the curve (AUC) 12 wk after intervention using the EQ-5D-5L questionnaire. The primary economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained at 12 mo after randomisation.
The mean health status AUCs over 12 wk were 0.807 (standard deviation [SD] 0.205) for FURS (n = 164) and 0.826 (SD 0.207) for ESWL (n = 188); the between-group difference was 0.024 (95% confidence interval -0.004, 0.053), a small nonsignificant difference in favour of FURS adjusted for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than with ESWL (36%). The incremental cost-effectiveness ratio between FURS and ESWL was £65 163, meaning that at a threshold value of £20 000 per QALY, ESWL has a >99% chance of being cost effective.
PUrE RCT 1 found that there was no evidence of a difference in health status between FURS and ESWL for LPSs of ≤10 mm, with FURS leading to a higher stone-free rate. ESWL was more cost effective than FURS.
欧洲泌尿外科学会指南推荐，体外冲击波碎石术（ESWL）和软性输尿管肾镜检查（FURS）是下极肾结石（LPS）同样合适的一线治疗选择。我们报告了一项实用的多中心、开放标签、优效性随机对照试验（RCT），比较FURS与ESWL对生活质量的影响，以及对直径≤10 mm的LPS的临床疗效和成本效益——这是经皮肾镜取石术、软性输尿管镜检查和体外冲击波碎石术治疗下极肾结石研究（PUrE）中的两项RCT之一，另一项PUrE RCT 2研究的是更大的结石。
总共231例和230例患者分别被随机分配至FURS组和ESWL组。主要结局是使用EQ-5D-5L问卷评估干预后12周的健康状况曲线下面积（AUC）。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（QALY）的增量成本。
FURS组（n = 164）12周内的平均健康状况AUC为0.807（标准差[SD] 0.205），ESWL组（n = 1）为0.826（SD 0.207）；组间差异为0.024（95%置信区间-0.004，0.053），在对初始基线不平衡进行调整后，这是一个有利于FURS的小的非显著差异。FURS的结石完全清除率（72%）高于ESWL（36%）。FURS与ESWL之间的增量成本效益比为65163英镑，这意味着在每QALY阈值为20000英镑的情况下，ESWL具有>99%的成本效益可能性。
PUrE RCT 1发现，对于直径≤10 mm的LPS，没有证据表明FURS与ESWL在健康状况方面存在差异，FURS导致更高的无石率。ESWL比FURS更具成本效益。
