CRediT contribution statement
Oliver Wiseman (https://orcid.org/0000-0001-8039-6903) (Consultant Urologist): Conceptualisation, Methodology, Funding acquisition, Investigation, Supervision, Writing – original draft (equal lead), Writing – reviewing and editing.
Daron Smith (https://orcid.org/0000-0001-8314-4795) (Endoluminal Endourologist): Conceptualisation, Methodology, Funding acquisition, Investigation, Supervision, Writing – original draft (equal lead), Writing – reviewing and editing.
Kath Starr (https://orcid.org/0000-0003-3356-7751) (Senior Trial Manager): Conceptualisation, Methodology, Funding acquisition, Investigation, Project administration, Supervision, Writing – reviewing and editing.
Lorna Aucott (https://orcid.org/0000-0001-6277-7972) (Senior Statistician): Methodology, Formal analysis, Visualisation, Writing – original draft (equal lead), Writing – reviewing and editing.
Rodolfo Hernández (https://orcid.org/0000-0003-2619-8230) (Health Economist): Conceptualisation, Methodology, Funding acquisition, Formal analysis, Visualisation, Writing – original draft (equal lead), Writing – reviewing and editing.
Ruth Thomas (https://orcid.org/0000-0002-8316-2616) (Triallist, Research Manager): Methodology, Funding acquisition, Project administration, Writing – original draft (lead), Writing – reviewing and editing.
Steven MacLennan (https://orcid.org/0000-0002-2691-8421) (Senior Research Fellow): Conceptualisation, Methodology, Funding acquisition, Investigation, Writing – original draft (equal lead), Writing – reviewing and editing.
Charles Terry Clark (https://orcid.org/0000-0003-1813-9767) (PPI): Methodology, Funding acquisition, Writing – reviewing and editing, PPI.
Graeme MacLennan (https://orcid.org/0000-0002-1039-5646) (Professor/CHaRT Director/Triallist): Conceptualisation, Methodology, Funding acquisition, Supervision, Validation, Writing – reviewing and editing.
Dawn McRae (https://orcid.org/0009-0009-0553-1453) (Trial Manager): Methodology, Investigation, Project administration, Supervision, Writing – reviewing and editing.
Victoria Bell (https://orcid.org/0000-0001-9518-9296) (Trial Manager): Project administration, Investigation, Writing – reviewing and editing.
Seonaidh Cotton (https://orcid.org/0000-0002-7883-0608) (Senior Trial Manager): Project administration, Supervision, Writing – reviewing and editing.
Zara Gall (https://orcid.org/0000-0002-8494-672X) (Consultant Urologist): Investigation, Supervision, Writing – reviewing and editing.
Ben Turney (https://orcid.org/0000-0003-0885-6404) (Consultant Urologist): Concept, Funding acquisition, Investigation, Writing – reviewing and editing.
Samuel McClinton (https://orcid.org/0000-0002-0539-9570) (Professor/Consultant Urologist): Concept, Methodology, Funding acquisition (lead), Investigation, Supervision, Writing – reviewing and editing.
Other contributions:
Charles Terry Clark in addition has been involved as a PPI team member since conception of the trial and oversaw the conduct of the trial and the interpretation of results and the writing/editing of the report.
Acknowledgements
The Health Services Research Unit (HSRU) and the Health Economics Research Unit (HERU) are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed by authors in this publication are those of the authors. The authors accept full responsibility for this publication.
The authors thank all the patients who participated in PUrE.
A special thanks goes to the trial 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).
We thank 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.
Thanks to Mr Rodolfo Agustín Hernández and Mr Andrés G. Hernández for retrieving HRG based unit costs for hospital interventions based on the PUrE data and following NHS costing algorithm (NHS Digital: Casemix Companion HRG+ 2020/21 and HRG+ Reference Costs Code to Group).
We thank the members of the PMG for their ongoing advice and support of the trial, plus the independent members of the TSC and DMC; and the staff at the recruitment sites who facilitated the recruitment, treatment and follow-up of trial participants (all listed below). Finally, we thank the National Institute for Health Research and the Health Technology Assessment Programme for funding the PUrE study.
Independent members of the Trial Steering Committee
Nigel Parr (Chair), Linda Harper, Jeff Hussey, Barbara Farrell, Tim Everitt (PPI).
Independent members of the Data Monitoring Committee
Steve Payne (Chair), Robert Hills, David Douglas.
Project Management Group
Grant Holders: Ken Anson, Terry Clark, Rodolfo Hernández, Thomas Lam, Graeme MacLennan, Steven MacLennan, Samuel McClinton, Robert Pickard, Daron Smith, Kath Starr, David Thomas, Ruth Thomas, Ben Turney, Oliver Wiseman, and the CHaRT Trial Office.
Clinical centres
Thanks to all staff at NHS sites responsible for recruitment in the clinical centres as follows:
Ashford and St Peter’s Hospitals NHS Foundation Trust (Ashford and St Peter’s):
Sachin Agrawal (PI), Nimalan Arumainayagam, Iain Burton, Maria Croft, Victoria Frost, Keshnie Govender, Catherine Gray, Stephanie Ivie, Megan McGee. Belfast Health and Social Care Trust (Belfast): David Connolly (PI), Jay Atkinson, Karen Johnston, Ajay Pahuja, Trevor Thompson, Christina Wilson, Siobhan Woolsey. Betsi Cadwaladr University Health Board (Wrexham): Iqbal Shergill (PI), Stacy Ackerley, Issah Ahmed, Mohamed Yehia Ahmed Abdallah, Annette Bolger, Sally Dolan, Emma Hall, Rachel Hughes, Tania Morgan, Mary Roberts, Jane Stockport, Heather Thomas, Lewis Waggett, Claire Watkins. Blackpool Teaching Hospitals NHS Foundation Trust (Blackpool): Chandrasekharan Badrakumar (PI), Jaginkere Chiran (PI), Denise Bennett, Paul Billington, Gemma Brown, Janet Brown, Shamina Hankinson, Carol Jeffs, Alex Maley, Praveen Rao, Ella Riedel, Emma Stoddard, Mohamed Youssef. Bradford Teaching Hospitals NHS Foundation Trust (Bradford): James Forster (PI), Richard Benton, Kay Cockroft, Hayley Inman, Charlotte Johnson-Smith, Anne Kay, Gail Opio-te, Helen Robertshaw, Jane Sewell, Kelvin Stewart, Sarah Tinker. Cambridge University Hospitals NHS Foundation Trust (Cambridge): Oliver Wiseman (PI), Kelly Leonard, Lorraine Starling. Dartford and Gravesham NHS Trust (Darent Valley): Seshadri Sriprasad (PI), Jayasimha Abbaraju, Faqar Anjum, Protip Bose, Ryan Coe, Tom D’Angelo, Tracy Edmunds, Anca Gherman, Musaad Hamdoon, Charlotte Kamundi, M Melhem, Subrabrata Muknerjee, Jospeh Nariculum, Naomi Oakley, Olumide Olufuwa, Eleanor Ray, Christine Scott, Carmel Stuart, Sherma Turner, Danielle Whitting. East Kent Hospitals University NHS Foundation Trust (Canterbury): Jemma Hale (PI), Nitin Shrotri (PI), Noor Gifford, Sashi Kommu, Angela Moon, Janine Musselwhite, Joshua O’Donnell, Pam Offord, Rachel Vernall. East Lancashire Hospitals NHS Trust (Blackburn): Shalom Srirangam (PI), Gaynor Bowen, Stephen Duberley, Jillian Fitchett, Karl Worrall. East Sussex Healthcare NHS Trust (Eastbourne): Simon Mackie (PI), Anne Cowley, Emma Edmunds, Jenny Law, Kelly Mintrim, Claire Rutherford. Epsom and St Helier University Hospitals NHS Trust (Epsom): Stephen Gordon (PI), Rosavic Chicano, Rachel Hayre, Ben Horsburgh, Lisheng Hou, Pareeta Patel, Neringa Vilimiene. Gloucestershire Hospitals NHS Foundation Trust (Cheltenham): Kim Davenport (PI), Adnan Ahmad, Susan Beames, John Henderson, Joseph Jelski, Bashir Mohamed (Associate PI), Jonathan Ord, Paula Townsend, Amanda Tyler. Imperial College Healthcare NHS Trust (Charing Cross): Ranan Dasgupta (PI), Zaynab Al-Saad, Sanela Andrijac, Tamer El-Husseiny, Lynsey Evison, Christine Gan, Milad Hanna, Marya Hussain, Stephanie Ivie, Ella Jameson, Angelina Karatziotou, Mitra Kondjin-Smith, Laura McLeavy, Rhea Strudwick, Thilipan Thaventhiran. Kingston Hospital NHS Foundation Trust (Kingston): Rashmi Singh (PI), Isabel Bradley, Jennifer Crooks, Rita Fernandes, Jefferson Lisboa Santos, Tracey O’Brien, Andrew Swain. Leeds Teaching Hospitals NHS Trust (Leeds): Michael Kimuli (PI), Irfan Jina, Lorraine Wiseman. Liverpool University Hospitals NHS Trust (formerly Royal Liverpool and Broadgreen University Hospitals NHS Trust) (Liverpool): Ciaran Lynch (PI), Patricia Kelly. London North West University Healthcare NHS Trust (Northwick Park): Erik Havranek (PI), Temi Adedoyin, Annamaria Harmathova, Asif Raza, Jeff Webster. Manchester University NHS Foundation Trust (formerly Central Manchester University Hospitals NHS Foundation Trust) (Central Manchester): Ben Grey (PI), Houda Chea, Ann Crump, Laura Derbyshire, Babra Hanif, Natasha Jones, Iain McIntyre, Richard Napier-Hemy, Mohammed Nazir, Anne Palmer, Laura Perry, Angelique Quistin, David Triggs, Ian Venebles. Manchester University NHS Foundation Trust (formerly University Hospital of South Manchester NHS Foundation Trust) (Wythenshawe): Graham Young (PI), Karyee Chow, Thiruendran Gunendran, Rebecca Ilyas. Mid and South Essex NHS Foundation Trust (formerly Mid Essex Hospital Services NHS Trust) (Broomfield): Daniel Swallow (PI), Mandy Austin, Tracey Camburn, Lauren Fergery, Fiona McNeela, Sue Smolen, Petros Tsafrakidis. Mid Yorkshire Hospitals Trust (Wakefield): Abed Ali (PI), Anthony Browning (PI), Stephanie Symons (PI), Jim Anderson, Hollie Brooke, Paul Hughes, Stephen Littler, Beverley Taylor. Newcastle Upon Tyne Hospitals NHS Foundation Trust (Newcastle): David Thomas (PI), Nicola Brown, Alexandra Hall, Paul Hindmarch, Ann Hudson, Bernadette Kilbane, Lynn Langhorne, Peter Murphy, Wendy Robson, Dianne Wake. NHS Fife (formerly Fife Health Board) (Kircaldy): Robyn Webber (PI), Laura Beveridge, Susan Pick. NHS Grampian (formerly Grampian Health Board) (Aberdeen): Ismail El-Mokadem (PI), Samuel McClinton (PI), Angela Allan, Kim Black, Maeve Dooher, Gayle Hutcheon, Sandra Mann, Deborah Price, Abdul Rauf, Lorna van Lierop, Lynne Walker, Nicholas Cohen, Thomas Lam. NHS Lothian (formerly Lothian Health Board) (Edinburgh): Mark Cutress (PI), Carol Ann Stephenson, Rachael Campbell, Kareen Darnley, Siatos Dimitrios, James Donaldson, Daniel Good, Sarah KcKim, Katherine Lawrence, Simon Phipps, Hazel Smith, Catherine Somerville, Ben Thomas, Maggie Wishart. Norfolk and Norwich University Hospitals NHS Foundation Trust (Norfolk and Norwich): Stuart Irving (PI), Neil Burgess, Karen Convery, Patricia Dickens, William Finch, Deirdre Fottrell-Gould, Janette Guymer, Lisa Hudig, Jocelyn Keshet-Price, Martyn Oliver, Gill Pout, Emily Tropman. North Bristol NHS Trust (Bristol Southmead): Francis Keeley (PI), Rebecca Cousins, Lyndsey Johnson, Leigh Morrison, Emily Perry, Joe Philip, Constance Shiridzinomwa, Sophie Short, Anthony Timoney. Northern Care Alliance NHS Foundation Trust (formerly Salford Royal NHS Foundation Trust) (Salford): David Ross (PI), Nicholas Boxall, Euan Green, Victoria Thomas. Northern Care Alliance NHS Foundation Trust (formerly Pennine Acute Hospitals NHS Trust) (Oldham): Andreas Bourdomis (PI), Dionne Adams, Mariya Barakova, Carolyn Corbett, Susan Dermody, Karen Hallett, Zahid Hussain, Joanne Johnson, Dann Johnstone, Simon Kaye, Susan Kernan, Louise Morby, Lyndsay Scarratt, Raveendra Surange, Sarah Winnard, Lynne Winstanley. Oxford University Hospitals NHS Foundation Trust (Oxford): Ben Turney (PI), Emily Grout. Rotherham NHS Foundation Trust (Rotherham): Bo Parys (PI), Dawn Collier, Katy Curtis, Kathryn Dixon, Victoria Murray, Rachel Walker. Royal Berkshire NHS Foundation Trust (Reading): Sunil Kumar (PI), Caroline Hayden, Johanna Thomas, Karen Wilmott. Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust (Bournemouth): Joshua Phillips (PI), Andrew Bates, Norbert Boker, Emma Bromwich, Maria Letts, Tina Stoycheva, Luke Vamplew, Steven Williams. Royal Cornwall Hospital NHS Trust (Royal Cornwall): Christopher Blake (PI), Benita Adams, Nicki Devooght-Johnson, Eve Fletcher, Fiona Hammonds, Emma Lamarti, Mark Mantle, Catherine Miller, Anna Old, Hannah Osborn, Jessica Summers, Sue Webber, Lucy Whitbread, Belinda Wroath, Gabby Young. Royal Devon University Healthcare NHS Foundation Trust (formerly Royal Devon and Exeter NHS Foundation Trust) (Exeter): Melanie Walton (PI), Angela Cottrell, Thomas Dutton, Melanie Hutchings, Joseph John, Sinead Kelly, Victoriano Mariano III, Evanna McEvoy, Rachelle Meyer, Madeline Moore, Linda Park, John Pascoe, Pauline Sibley, Michelle Walter. Salisbury NHS Foundation Trust (Salisbury): James Brewin (PI), Moyeen Bakar, Sa’id Dabah Aljamal, Sarah Diment, Victoria King, Holly Morgan, Mostafa Ragab, Abby Rand, Ben Wilson. Sheffield Teaching Hospitals Foundation Trust (Sheffield): Jake Patterson (PI), Anne Frost, James Hall, Susannah Hulton, Sanjay Rajpal. South Tees Hospitals NHS Foundation Trust (Middlesborough): Ashok Sakthivel (PI), Chandrasekharan Badrakumar (Associate PI), Basavaraj Gowda (Associate PI), Alaiyi West (Associate PI), Susan Walker. South Tyneside and Sunderland NHS Foundation Trust (formerly City Hospitals Sunderland NHS Foundation Trust) (Sunderland): David Bryant (PI), Sue Asterling, Eleanor Dungca, Deborah Kemp, Jenny Koo Ng, Gareth Lewis, Stuart McCracken, Ameet Patel. Southport and Ormskirk Hospitals NHS Trust (Southport): Rahul Mistry (PI), Anna Morris. St George’s University Hospitals NHS Foundation Trust (St. George’s): Kenneth Anson (PI), Christina Armoogum, Marco Bolgeri, Elizabeth Cruddas, Deirdre Daly, Cherrelle De Souza, Mark Lynch, Kristoffer Ohlin, Sarah Rounding, Agne Sekmokaite, Rashmi Singh. St Helens and Knowsley Teaching Hospitals NHS Trust (Whiston): John McCabe (PI), Karen Chadwick, Sharon Dealing, Susan Dowling, Sandra Greer, Clare Harrop. Stockport NHS Foundation Trust (Stockport): Zara Gall (PI), Adebanji Adeyoju, Louise Brown, Patricia Clitheroe, Sarah Connolly, Patricia Coughlan, Janette Curtis, Emma Goodwin, Helen Haydock, Rion Healy, Sheila Hodgkinson, Susan Hopkins, Alissa Kent, Magda Lucia Kujawa, Sean Rezvani, Sarah Smallwood, Lara Smith, Clare Tibke. University Hospital Southampton NHS Foundation Trust (Southampton): Bhaskar Somani (PI), Andrew Guy, Mark Harris, Kimberley Harris, Clare Hutchison, Shery Michael, Abbie Morley, McDonald Mupudzi, Amelia Pietropaolo, Winningtom Ruiz, Ana Salgueiro, Mariya Shaji, Sanchia Triggs, Hannah Wardall. University Hospitals Coventry and Warwickshire NHS Trust (Coventry): Anthony Blacker (PI), Dannielle Burgess, Davina Hewitt, Samantha Hyndman, Sarah O’Toole, Maria Truslove. University Hospitals Plymouth NHS Trust (formerly Plymouth Hospitals NHS Trust) (Plymouth): Andrew Dickinson (PI), Ivo Dukic (PI), Maria Brennan, Lyn Cogley, Sue Freemantle, Salvatore Natale. University Hospitals Sussex NHS Foundation Trust (formerly Western Sussex NHS Foundation Trust) (Western Sussex): Dan Magrill (PI), Isobel Amey, Yolanda Baird, Irvin Balagosa, Marian Flynn-Batham, Raquel Gomez, Susanna Greenslade, Sally Moore, Marian Nelmes, Matthew Smith, Tan Tsawayo, Paimaun Zakikhani.
University Hospitals Sussex NHS Foundation Trust (formerly Brighton and Sussex University Hospitals NHS Trust) (Brighton): Andrew Symes (PI), Paul Frattaroli, Allison Leslie, Lorraine Shah-Goodwin, Mel Smith, Kate Trivedi. Wirral University Teaching Hospital NHS Foundation Trust (Wirral): Snehal Patel (PI), Mandy Edwards, Richard Glendinning, Keith Morris, Andrea Young.
Sites opened but never recruited
NHS Highland (formerly Highland Health Board) (Inverness): Sara Ramsey (PI), Fiona Barrett, Kathleen MacLeod, Debbie McDonald. University Hospitals of Leicester NHS Trust (Leicester): Masood Khan (PI), Jane Douglas-Moore, Mandy Le-Butt, Shumikazi Mzazi.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Ethics statement
The PUrE study received favourable ethics opinion from North of Scotland Research Ethics Committee on the 12 November 2015 (REC reference number 15/NS/0113).
Information governance statement
The University of Aberdeen is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, the University of Aberdeen is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here www.abdn.ac.uk/privacy.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/WFRE6844.
Primary conflicts of interest: Daron Smith, Kath Starr, Lorna Aucott, Rodolfo Hernández, Ruth Thomas, Steven MacLennan, Graeme MacLennan, Seonaidh Cotton and Samuel McClinton report: NIHR HTA funding award for the PUrE trial 13/152/02 during the conduct of the study. Oliver Wiseman reports: grants from the EMS and Coloplast institutions; consulting fees from Boston Scientific, EMS, Coloplast and Ambu organisations; and payments from Boston Scientific, EMS, Coloplast and Devicare, during the conduct of the study. Daron Smith reports: grant for stent design, Award ID: NIHR202935 (CASSETTE), invoices in progress for Olympus KeyMed for lecture/course delivery for SpR Education and for plenary lecture at BAUS during 2022; payments received for Webinar support from Cook and Coloplast organisations; honorary board membership of the Endourology Academy; and honorary committee membership for World of Endourology Society, during the conduct of this study. Lorna Aucott reports: membership of PHR Research Funding Board between 13 June 2017 and 12 June 2023 and COVID-19 Reviewing between 1 June 2020 and 30 September 2020 during the conduct of this study. Zara Gall reports: payments from Boston Scientific for speaking at Symposium on Ureteroscopy at BAUS in June 2022 and for organisation and delivery of PCNL course in April 2023; and committee membership of BAUS Endourology February 2000–February 2023. Ben Turney reports: multiple research grants to support PhD students and research projects from Boston Scientific, research grant to investigate the genetics of BPH from the Urology foundation and joint industry/ESPRC funding to support mathematics and engineering students. BT also reports consulting fees from Boston Scientific; payments or honoraria from Boston Scientific and from Devicare; participation on International Advisory Board for Boston Scientific; leadership/advisory role for Wellbeck Oxford; stock with Ambulatory Surgery International; and receipt of research project equipment from Boston Scientific. Patents reported by Ben Turney are: New Invention Disclosure #21-D0431(Multi-class segmentation in ureteroscopy and laser lithotripsy) (filed September 2022), New Invention Disclosure: #22-D0371 (Automated Estimation of Stone Size in Laser Lithotripsy) (filed September 2022), and New Invention Disclosure: #17-D0422 (Visualization through Non–Circular Sheath Via Optimized Fluid Dynamic in Channel Flow) during the conduct of this study.
Publications
Wiseman O, Smith D, Starr K, Aucott L, Hernández R, Thomas R, et al. The PUrE randomised controlled trial 1: Clinical and cost effectiveness of flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole stones of ≤10 mm. Eur Urol 2025;88(2):179–89. https://doi.org/10.1016/j.eururo.2025.02.002
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.