The European Association of Urology guidelines for lower-pole stones (LPS) recommend percutaneous nephrolithotomy (PCNL) for stones >20 mm, flexible ureterorenoscopy (FURS) or PCNL for stones of 10-20 mm if there are unfavourable factors for extracorporeal shockwave lithotripsy (ESWL), or any of these options for stones of 10-20 mm if there are no unfavourable factors for ESWL. PUrE RCT 2 was a pragmatic multicentre, open-label, superiority, randomised controlled trial comparing FURS versus PCNL in terms of quality of life, clinical effectiveness, and cost effectiveness for patients with LPS of 10-25 mm.
A total of 159 adults with LPS of 10-25 mm were randomised, 73 to FURS and 86 to PCNL. The primary outcome was health status area under the curve (AUC) measured weekly using the EQ-5D-5L questionnaire up to 12 wk after intervention. The primary economic outcome was the incremental cost per quality-adjusted life year (QALY) gained at 12 mo from randomisation.
Mean health status AUC slightly favoured PCNL (difference -0.07, 95% confidence interval [CI] -0.11 to -0.02) when adjusted for baseline status. The complete stone clearance rate was higher with PCNL (71%) than with FURS (48%). PCNL was less costly (adjusted mean difference £733, 95% CI -£508 to £1973) and resulted in greater QALYs (adjusted mean difference -0.001, 95% CI -0.044 to 0.042). At a threshold value of £20 000 per QALY, PCNL has an 87% chance of being cost-effective.
Results from PUrE RCT 2 show that PCNL resulted in marginally better health status and a higher stone-free rate and was more cost-effective than FURS among patients with LPS of 10-25 mm. These outcomes are important for patient counselling and joint decision-making on LPS treatment.
European urology focus. 2025 Sep 25 [Epub ahead of print]
Daron Smith, Oliver Wiseman, 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
Stone and Endourology Unit, University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK. Electronic address: ., Department of Urology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, 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, University of Aberdeen, Aberdeen, UK., 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, Aberdeen, UK.