Wiseman O. et al., 2025: The PUrE randomised controlled trial 1: Clinical and cost effectiveness of flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole stones of ≤10 mm.

Oliver Wiseman, Daron Smith, Kathryn Starr, Lorna Aucott, Rodolfo Hernández, Ruth Thomas, Steven MacLennan, Charles Terry Clark, Graeme MacLennan, Dawn McRae, Victoria Bell , Seonaidh Cotton, Zara Gall, Ben Turney, Sam McClinton 
Eur Urol. 2025 Apr 22:S0302-2838(25)00071-5. doi: 10.1016/j.eururo.2025.02.002 FREE ARTICLE

Abstract

Background and objective: 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.

Methods: 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.

Key findings and limitations: 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.

Conclusions and clinical implications: 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.

Comment Peter Alken

What a relief to read such a good, high quality paper! European Urology seems to have changed its former policy of not publishing manuscripts on urolithiasis. Probably because they have realized that this is an important urological entity in many ways, from incidence rates to quality of life to health care costs. This publication is even marked as an "Editor's choice". It is an open access must read because, unlike many other articles on the subject, it does not neglect topics such as quality of life and health care costs, but takes them specifically as target topics.
What I miss are data about DJ-application which - if done - should have a negative impact on quality of life and pain. In this respect the reader should download the supplementary material which gives some hints on these factors with data on pain.
What surprised me were the GB waiting times until treatment compared to much better data from Italy in a comparable time period (1). The Italian group defined the mean waiting time as time from booking to treatment for elective procedures delivered – probably identical to the not specified GB WT.

1 Present study
2 Mazzon G, et al. COVID-19 outbreak impact on urolithiasis treatments: A multicenter retrospective study across 9 urological centers in Italy. Curr Urol. 2024 Dec;18(4):301-306. doi: 10.1097/CU9.0000000000000246. Epub 2024 Apr 13. PMID: 40256306; PMCID: PMC12004962.

Peter Alken