The PUrE Randomised Controlled Trial (RCT) 1:: Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm.

Oliver J. Wiseman; Daron Smith; Kathryn Starr; Lorna Aucott; Rodolfo Andrés Hernández; Ruth Thomas; Steven MacLennan; Charles Terry Clark; Graeme MacLennan; Dawn McRae; Victoria Bell; Seonaidh Cotton; Zara  Gall; Ben Turney; Sam McClinton

The PUrE Randomised Controlled Trial (RCT) 1: Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm.

Oliver J. Wiseman^* (Corresponding Author), Daron Smith, Kathryn Starr, Lorna Aucott, Rodolfo Andrés Hernández, Ruth Thomas, Steven MacLennan, Charles Terry Clark, Graeme MacLennan, Dawn McRae, Victoria Bell, Seonaidh Cotton, Zara Gall, Ben Turney, Sam McClinton

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background and Objectives
EAU guidelines recommend that lithotripsy (ESWL) and flexible ureterorenoscopy (FURS) are equally appropriate first-line treatment options for lower pole renal stones (LPS). We report a pragmatic multicentre, open-label, superiority randomised controlled trial comparing FURS vs ESWL for quality of life, clinical- and costeffectiveness for LPS ≤10 mm, one of two RCTs which were part of PUrE, The Percutaneous nephrolithotomy, flexible Ureteroscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone study, with RCT2, investigating larger stones.
Methods:
231 and 230 patients were randomised to FURS and ESWL respectively. The primary outcome was health status Area Under the Curve (AUC), to 12 weeks post-intervention using the EQ-5D-5L. The primary economic outcome was the incremental cost per
quality-adjusted-life-year (QALYs) gained at twelve months post-randomisation.
Key finding and limitations: Mean health status AUC over twelve weeks was 0.807 (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% CI -0.004, 0.053), a small non-significant difference in favour of FURS adjusted for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). The incremental cost-effectiveness ratio (ICER) between FURS and ESWL was £65,163, meaning that at a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective.
Conclusions and clinical implications:
PUrE RCT1 found there was no evidence of a difference in health status between FURS and ESWL for LPS ≤10mm, with FURS leading to a higher stone-free rate. ESWL was more cost effective than FURS.

Original language	English
Journal	European Urology
Publication status	Accepted/In press - 5 Feb 2025

Bibliographical note

Special thanks must go to all of the PUrE trial participants. Thank you to all the staff at each of our recruiting centres for taking part in this trial. We thank our collaborators at the PUrE sites, and participating National Health Service (NHS) trusts: Ashford and St Peter's Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Betsi Cadwaladr University Health Board, Blackpool Teaching Hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Dartford & Gravesham NHS Trust, East Kent Hospitals University NHS Foundation Trust,, East Lancashire Hospitals NHS Trust, East Sussex Healthcare NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Kingston Hospital NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, Liverpool University Hospitals NHS Trust (formerly Royal Liverpool & Broadgreen University Hospitals NHS Trust), London North West University Healthcare NHS Trust, Manchester University NHS Foundation Trust (formerly Central Manchester University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust (formerly University Hospital of South Manchester NHS Foundation Trust), Mid and South Essex NHS Foundation Trust (formerly Mid Essex Hospital Services NHS Trust), Mid Yorkshire Hospitals Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust NHS Fife, NHS Grampian, NHS Lothian, Norfolk and Norwich University Hospitals NHS Foundation Trust, North Bristol NHS Trust, Northern Care Alliance NHS Foundation Trust (formerly Salford Royal NHS Foundation Trust and formerly Pennine Acute Hospitals NHS Trust), Oxford University Hospitals NHS Foundation Trust, Rotherham NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Royal Cornwall Hospital NHS Trust, Royal Devon University Healthcare NHS Foundation Trust (formerly Royal Devon and Exeter NHS Foundation Trust), Salisbury NHS Foundation Trust, Sheffield Teaching Hospitals Foundation Trust, South Tees Hospitals NHS Foundation Trust , South Tyneside and Sunderland NHS Foundation Trust (formerly City Hospitals Sunderland NHS Foundation Trust), Southport and Ormskirk Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, Stockport NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals Plymouth NHS Trust (formerly Plymouth Hospitals NHS Trust), University Hospitals Sussex NHS Foundation Trust (formerly Western Sussex NHS Foundation Trust), University Hospitals Sussex NHS Foundation Trust (formerly Brighton and Sussex University Hospitals NHS Trust), Wirral University Teaching Hospital NHS Foundation Trust.

We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. The trials managers and data coordinators who helped support the study: Katie Banister, Sarah Cameron, Karen Campbell, Tracey Davidson, Alison McDonald, Jess Wood (Trial Managers), Zoe Batham, Rebecca Bruce, Dianne Dejean and Sharon Wren (Data Co-ordinators) and the CHaRT programming team led by Mark Forrest and other staff within CHaRT/HSRU for their assistance with PUrE: Paul Manson, Information Scientist, Samantha Wileman, Quality Assurance Manager.

We also thank the members of our Project Management Group, TSC and DMC for their expert support and guidance.

Data Availability Statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Wiseman, O. J., Smith, D., Starr, K., Aucott, L., Hernández, R. A., Thomas, R., MacLennan, S., Clark, C. T., MacLennan, G., McRae, D., Bell, V., Cotton, S., Gall, Z., Turney, B., & McClinton, S. (Accepted/In press). The PUrE Randomised Controlled Trial (RCT) 1: Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm. European Urology.

Wiseman, OJ, Smith, D, Starr, K, Aucott, L, Hernández, RA , Thomas, R , MacLennan, S, Clark, CT, MacLennan, G, McRae, D, Bell, V, Cotton, S, Gall, Z, Turney, B & McClinton, S 2025, 'The PUrE Randomised Controlled Trial (RCT) 1: Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm.', European Urology.

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title = "The PUrE Randomised Controlled Trial (RCT) 1:: Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm.",

abstract = "Background and ObjectivesEAU guidelines recommend that lithotripsy (ESWL) and flexible ureterorenoscopy (FURS) are equally appropriate first-line treatment options for lower pole renal stones (LPS). We report a pragmatic multicentre, open-label, superiority randomised controlled trial comparing FURS vs ESWL for quality of life, clinical- and costeffectiveness for LPS ≤10 mm, one of two RCTs which were part of PUrE, The Percutaneous nephrolithotomy, flexible Ureteroscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone study, with RCT2, investigating larger stones. Methods:231 and 230 patients were randomised to FURS and ESWL respectively. The primary outcome was health status Area Under the Curve (AUC), to 12 weeks post-intervention using the EQ-5D-5L. The primary economic outcome was the incremental cost perquality-adjusted-life-year (QALYs) gained at twelve months post-randomisation. Key finding and limitations: Mean health status AUC over twelve weeks was 0.807 (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% CI -0.004, 0.053), a small non-significant difference in favour of FURS adjusted for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). The incremental cost-effectiveness ratio (ICER) between FURS and ESWL was £65,163, meaning that at a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective.Conclusions and clinical implications:PUrE RCT1 found there was no evidence of a difference in health status between FURS and ESWL for LPS ≤10mm, with FURS leading to a higher stone-free rate. ESWL was more cost effective than FURS.",

author = "Wiseman, {Oliver J.} and Daron Smith and Kathryn Starr and Lorna Aucott and Hern{\'a}ndez, {Rodolfo Andr{\'e}s} and Ruth Thomas and Steven MacLennan and Clark, {Charles Terry} and Graeme MacLennan and Dawn McRae and Victoria Bell and Seonaidh Cotton and Zara Gall and Ben Turney and Sam McClinton",

note = "Special thanks must go to all of the PUrE trial participants. Thank you to all the staff at each of our recruiting centres for taking part in this trial. We thank our collaborators at the PUrE sites, and participating National Health Service (NHS) trusts: Ashford and St Peter's Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Betsi Cadwaladr University Health Board, Blackpool Teaching Hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Dartford & Gravesham NHS Trust, East Kent Hospitals University NHS Foundation Trust,, East Lancashire Hospitals NHS Trust, East Sussex Healthcare NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Kingston Hospital NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, Liverpool University Hospitals NHS Trust (formerly Royal Liverpool & Broadgreen University Hospitals NHS Trust), London North West University Healthcare NHS Trust, Manchester University NHS Foundation Trust (formerly Central Manchester University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust (formerly University Hospital of South Manchester NHS Foundation Trust), Mid and South Essex NHS Foundation Trust (formerly Mid Essex Hospital Services NHS Trust), Mid Yorkshire Hospitals Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust NHS Fife, NHS Grampian, NHS Lothian, Norfolk and Norwich University Hospitals NHS Foundation Trust, North Bristol NHS Trust, Northern Care Alliance NHS Foundation Trust (formerly Salford Royal NHS Foundation Trust and formerly Pennine Acute Hospitals NHS Trust), Oxford University Hospitals NHS Foundation Trust, Rotherham NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Royal Cornwall Hospital NHS Trust, Royal Devon University Healthcare NHS Foundation Trust (formerly Royal Devon and Exeter NHS Foundation Trust), Salisbury NHS Foundation Trust, Sheffield Teaching Hospitals Foundation Trust, South Tees Hospitals NHS Foundation Trust , South Tyneside and Sunderland NHS Foundation Trust (formerly City Hospitals Sunderland NHS Foundation Trust), Southport and Ormskirk Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, Stockport NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals Plymouth NHS Trust (formerly Plymouth Hospitals NHS Trust), University Hospitals Sussex NHS Foundation Trust (formerly Western Sussex NHS Foundation Trust), University Hospitals Sussex NHS Foundation Trust (formerly Brighton and Sussex University Hospitals NHS Trust), Wirral University Teaching Hospital NHS Foundation Trust. We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. The trials managers and data coordinators who helped support the study: Katie Banister, Sarah Cameron, Karen Campbell, Tracey Davidson, Alison McDonald, Jess Wood (Trial Managers), Zoe Batham, Rebecca Bruce, Dianne Dejean and Sharon Wren (Data Co-ordinators) and the CHaRT programming team led by Mark Forrest and other staff within CHaRT/HSRU for their assistance with PUrE: Paul Manson, Information Scientist, Samantha Wileman, Quality Assurance Manager. We also thank the members of our Project Management Group, TSC and DMC for their expert support and guidance. ",

year = "2025",

month = feb,

day = "5",

language = "English",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier",

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TY - JOUR

T1 - The PUrE Randomised Controlled Trial (RCT) 1:

T2 - Clinical and cost-effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for lower pole stones ≤10mm.

AU - Wiseman, Oliver J.

AU - Smith, Daron

AU - Starr, Kathryn

AU - Aucott, Lorna

AU - Hernández, Rodolfo Andrés

AU - Thomas, Ruth

AU - MacLennan, Steven

AU - Clark, Charles Terry

AU - MacLennan, Graeme

AU - McRae, Dawn

AU - Bell, Victoria

AU - Cotton, Seonaidh

AU - Gall, Zara

AU - Turney, Ben

AU - McClinton, Sam

N1 - Special thanks must go to all of the PUrE trial participants. Thank you to all the staff at each of our recruiting centres for taking part in this trial. We thank our collaborators at the PUrE sites, and participating National Health Service (NHS) trusts: Ashford and St Peter's Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Betsi Cadwaladr University Health Board, Blackpool Teaching Hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Dartford & Gravesham NHS Trust, East Kent Hospitals University NHS Foundation Trust,, East Lancashire Hospitals NHS Trust, East Sussex Healthcare NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Kingston Hospital NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, Liverpool University Hospitals NHS Trust (formerly Royal Liverpool & Broadgreen University Hospitals NHS Trust), London North West University Healthcare NHS Trust, Manchester University NHS Foundation Trust (formerly Central Manchester University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust (formerly University Hospital of South Manchester NHS Foundation Trust), Mid and South Essex NHS Foundation Trust (formerly Mid Essex Hospital Services NHS Trust), Mid Yorkshire Hospitals Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust NHS Fife, NHS Grampian, NHS Lothian, Norfolk and Norwich University Hospitals NHS Foundation Trust, North Bristol NHS Trust, Northern Care Alliance NHS Foundation Trust (formerly Salford Royal NHS Foundation Trust and formerly Pennine Acute Hospitals NHS Trust), Oxford University Hospitals NHS Foundation Trust, Rotherham NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Royal Cornwall Hospital NHS Trust, Royal Devon University Healthcare NHS Foundation Trust (formerly Royal Devon and Exeter NHS Foundation Trust), Salisbury NHS Foundation Trust, Sheffield Teaching Hospitals Foundation Trust, South Tees Hospitals NHS Foundation Trust , South Tyneside and Sunderland NHS Foundation Trust (formerly City Hospitals Sunderland NHS Foundation Trust), Southport and Ormskirk Hospitals NHS Trust, St George's University Hospitals NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, Stockport NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals Plymouth NHS Trust (formerly Plymouth Hospitals NHS Trust), University Hospitals Sussex NHS Foundation Trust (formerly Western Sussex NHS Foundation Trust), University Hospitals Sussex NHS Foundation Trust (formerly Brighton and Sussex University Hospitals NHS Trust), Wirral University Teaching Hospital NHS Foundation Trust. We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. We thank all staff at the PUrE trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen. The trials managers and data coordinators who helped support the study: Katie Banister, Sarah Cameron, Karen Campbell, Tracey Davidson, Alison McDonald, Jess Wood (Trial Managers), Zoe Batham, Rebecca Bruce, Dianne Dejean and Sharon Wren (Data Co-ordinators) and the CHaRT programming team led by Mark Forrest and other staff within CHaRT/HSRU for their assistance with PUrE: Paul Manson, Information Scientist, Samantha Wileman, Quality Assurance Manager. We also thank the members of our Project Management Group, TSC and DMC for their expert support and guidance.

PY - 2025/2/5

Y1 - 2025/2/5

N2 - Background and ObjectivesEAU guidelines recommend that lithotripsy (ESWL) and flexible ureterorenoscopy (FURS) are equally appropriate first-line treatment options for lower pole renal stones (LPS). We report a pragmatic multicentre, open-label, superiority randomised controlled trial comparing FURS vs ESWL for quality of life, clinical- and costeffectiveness for LPS ≤10 mm, one of two RCTs which were part of PUrE, The Percutaneous nephrolithotomy, flexible Ureteroscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone study, with RCT2, investigating larger stones. Methods:231 and 230 patients were randomised to FURS and ESWL respectively. The primary outcome was health status Area Under the Curve (AUC), to 12 weeks post-intervention using the EQ-5D-5L. The primary economic outcome was the incremental cost perquality-adjusted-life-year (QALYs) gained at twelve months post-randomisation. Key finding and limitations: Mean health status AUC over twelve weeks was 0.807 (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% CI -0.004, 0.053), a small non-significant difference in favour of FURS adjusted for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). The incremental cost-effectiveness ratio (ICER) between FURS and ESWL was £65,163, meaning that at a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective.Conclusions and clinical implications:PUrE RCT1 found there was no evidence of a difference in health status between FURS and ESWL for LPS ≤10mm, with FURS leading to a higher stone-free rate. ESWL was more cost effective than FURS.

AB - Background and ObjectivesEAU guidelines recommend that lithotripsy (ESWL) and flexible ureterorenoscopy (FURS) are equally appropriate first-line treatment options for lower pole renal stones (LPS). We report a pragmatic multicentre, open-label, superiority randomised controlled trial comparing FURS vs ESWL for quality of life, clinical- and costeffectiveness for LPS ≤10 mm, one of two RCTs which were part of PUrE, The Percutaneous nephrolithotomy, flexible Ureteroscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stone study, with RCT2, investigating larger stones. Methods:231 and 230 patients were randomised to FURS and ESWL respectively. The primary outcome was health status Area Under the Curve (AUC), to 12 weeks post-intervention using the EQ-5D-5L. The primary economic outcome was the incremental cost perquality-adjusted-life-year (QALYs) gained at twelve months post-randomisation. Key finding and limitations: Mean health status AUC over twelve weeks was 0.807 (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% CI -0.004, 0.053), a small non-significant difference in favour of FURS adjusted for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). The incremental cost-effectiveness ratio (ICER) between FURS and ESWL was £65,163, meaning that at a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective.Conclusions and clinical implications:PUrE RCT1 found there was no evidence of a difference in health status between FURS and ESWL for LPS ≤10mm, with FURS leading to a higher stone-free rate. ESWL was more cost effective than FURS.

M3 - Article

SN - 0302-2838

JO - European Urology

JF - European Urology

ER -