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.
European urology. 2025 Apr 22 [Epub ahead of print]
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
Department of Urology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK. Electronic address: ., Stone and Endourology Unit, University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK., Warwick Medical School, University of Warwick, Warwick, UK., Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Health Economics Research Unit, University of Aberdeen, Aberdeen, UK., Centre for Healthcare Randomised Trials, Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK., Academic Urology Unit, University of Aberdeen, Aberdeen, UK., Patient/public representative., Department of Urology, Stepping Hill Hospital, Stockport NHS Foundation Trust, Stockport, UK., Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Academic Urology Unit, University of Aberdeen, Aberdeen, UK; NHS Grampian.