PUrE Randomised Controlled Trial 2: Clinical and Cost Effectiveness of Flexible Ureterorenoscopy and Percutaneous Nephrolithotomy for Lower-pole Stones of 10–25 mm
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND AND OBJECTIVE: 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. METHODS: 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. KEY FINDING AND LIMITATIONS: 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. CONCLUSIONS AND CLINICAL IMPLICATIONS: 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.
Source: European Urology Focus
Institutions: University College Hospital, University College London Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, University of Warwick, University of Aberdeen, Stepping Hill Hospital, Stockport NHS Foundation Trust, University of Oxford, NHS Grampian
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,800
Funders: Central Manchester University Hospitals NHS Foundation Trust, Boston Scientific Corporation, Royal Devon and Exeter NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Betsi Cadwaladr University Health Board, University Hospitals Plymouth NHS Trust, National Institute for Health and Care Research, Imperial College Healthcare NHS Trust, University of Sussex, University of Aberdeen, Cambridge University Hospitals, Coloplast, Newcastle upon Tyne Hospitals NHS Foundation Trust, North Bristol NHS Trust, Oxford University Hospitals NHS Foundation Trust, Urology Foundation, Norfolk and Norwich University Hospitals NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Health Technology Assessment Programme, St. George's, University of London
Awards: G1895593380, Can novel ureteric stents offer a better patient outcome compared to existing standard ureteric stents (CASSETTE), G5586895465, G5918494183, G6660076446, G7336805680, G7781365041, The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the PUrE RCT - Percutaneous Nephrolithotomy (PNL), Flexible Ureterorenoscopy (FURS) and Extracorporeal Shockwave Lithotripsy (ESWL) for lower pole calyceal kidney stones
OpenAlex ID: W4414560313