Pd47-01 Pure RCT 1: Clinical and Cost-Effectiveness of Flexible Ureterorenoscopy and Extracorporeal Shockwave Lithotripsy for Lower Pole Stones ≤10 Mm

You have accessJournal of UrologyStone Disease: Surgical Therapy (Including ESWL) IV (PD47)1 May 2024PD47-01 PURE RCT 1: CLINICAL AND COST-EFFECTIVENESS OF FLEXIBLE URETERORENOSCOPY AND EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY FOR LOWER POLE STONES ≤10 MM Oliver Wiseman, Daron Smith, Kathryn Starr, Lorna Aucott, Rodolfo Hernández, Ruth Thomas, Steven MacLennan, Charles Clark, Graeme MacLennan, Dawn McRae, Victoria Bell, Seonaidh Cotton, Zara Gall, Ben Turney, and Sam McClinton Oliver WisemanOliver Wiseman , Daron SmithDaron Smith , Kathryn StarrKathryn Starr , Lorna AucottLorna Aucott , Rodolfo HernándezRodolfo Hernández , Ruth ThomasRuth Thomas , Steven MacLennanSteven MacLennan , Charles ClarkCharles Clark , Graeme MacLennanGraeme MacLennan , Dawn McRaeDawn McRae , Victoria BellVictoria Bell , Seonaidh CottonSeonaidh Cotton , Zara GallZara Gall , Ben TurneyBen Turney , and Sam McClintonSam McClinton View All Author Informationhttps://doi.org/10.1097/01.JU.0001008652.62443.0a.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Renal tract stone disease is common. The EAU guidelines recommend that lithotripsy (ESWL) and flexible ureteroscopic stone treatment (FURS) are equally appropriate first line treatment options including stones in the lower pole. A pragmatic multicentre, open-label, superiority randomised controlled trial was undertaken to determine which of ESWL or FURS offer the best outcomes in terms of quality of life, clinical effectiveness and cost-effectiveness for people with lower pole kidney stones ≤10 mm. This RCT received ethical approval from the North of Scotland National Health Service (NHS) Research Ethics Committee. METHODS: Eligible adults with stones ≤10 mm were randomised to ESWL or FURS across participating National Health Service (NHS) Urology departments. 461 patients were randomised; 231 to FURS; 230 to ESWL. The primary outcome measure was health status Area Under the Curve (AUC), measured weekly until 12 weeks post-intervention with EQ-5D-5L. The primary economic outcome was the incremental cost per quality-adjusted life year (ICER; QALYs) gained at twelve months from randomisation. RESULTS: Mean health status during these twelve weeks was 0.807 (SD 0.205) in the FURS group (n=164) and 0.826 (0.207) in the ESWL group (n=188), the between-group difference was 0.024 (95% CI -0.004, 0.053), a small difference in favour FURS after correcting for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). ICER was £65,163 per QALY gained by FURS. At a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective. Limitations of the study were that blinding of participants and health care providers was not possible. There were differential waiting times between interventions, however, adjusting for this gave similar treatment effect estimates. CONCLUSIONS: The PUrE study found that ESWL was more cost-effective than FURS for lower pole stones ≤10 mm, with no meaningful difference in patient health status despite the higher complete stone free rates with FURS. Source of Funding: The PUrE RCT was funded by the UK National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (project number 13/152/02). This abstract presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this abstract are those of the authors and do not necessarily reflect those of the NHS, the NIHR, Evaluation Trials and Studies Coordination Centre, the Health Technology Assessment programme or the UK Department of Health. The Health Services Research Unit (HSRU) and the Health Economics Research Unit (HERU), University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed by authors in this abstract are those of the authors.*Oliver Wiseman and Daron Smith are joint first authors © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e980 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Oliver Wiseman More articles by this author Daron Smith More articles by this author Kathryn Starr More articles by this author Lorna Aucott More articles by this author Rodolfo Hernández More articles by this author Ruth Thomas More articles by this author Steven MacLennan More articles by this author Charles Clark More articles by this author Graeme MacLennan More articles by this author Dawn McRae More articles by this author Victoria Bell More articles by this author Seonaidh Cotton More articles by this author Zara Gall More articles by this author Ben Turney More articles by this author Sam McClinton More articles by this author Expand All Advertisement PDF downloadLoading ...