{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T17:24:25Z","timestamp":1755797065235,"version":"3.44.0"},"reference-count":98,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["13\/152\/02"],"award-info":[{"award-number":["13\/152\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>Renal tract stone disease is common. The three intervention options are shockwave lithotripsy, flexible ureteroscopic stone treatment and keyhole surgery.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title>\n<jats:p>To determine which of shockwave lithotripsy, flexible ureteroscopic stone treatment and keyhole surgery offer the best outcomes in terms of health and\u00a0quality of life, clinical effectiveness and cost-effectiveness for people with lower pole kidney stones.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title>\n<jats:p>The PUrE study comprised two pragmatic multicentre, open-label, superiority randomised controlled trials: RCT1 for lower pole stones \u2264\u200510\u00a0mm and RCT2 for lower pole stones &gt;\u200510 and \u2264\u200525\u00a0mm.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title>\n<jats:p>National Health Service Urology departments.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title>\n<jats:p>Adults presenting with lower pole renal stones, able to undergo any of the treatments and complete trial procedures.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Intervention<\/jats:title>\n<jats:p>Eligible participants were randomised in RCT1\u00a0to flexible ureteroscopic stone treatment or shockwave lithotripsy; and in RCT2 to flexible ureteroscopic stone treatment or keyhole surgery.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title>\n<jats:p>The primary outcome measure was health status \u2018area under the curve\u2019, measured weekly to 12 weeks post intervention with the EuroQol-5 Dimensions, five-level version. The primary economic outcome was the incremental cost per quality-adjusted life-year gained at 12 months from randomisation.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title>\n<jats:p><jats:italic>RCT1:<\/jats:italic> A total of 461 participants were randomised: 231 to flexible ureteroscopic stone treatment; and 230 to shockwave lithotripsy. <jats:italic>RCT2:<\/jats:italic> A total of 159 participants were randomised: 73 to flexible ureteroscopic stone treatment; and 86 to keyhole surgery.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Primary outcome<\/jats:title>\n<jats:p><jats:italic>RCT1:<\/jats:italic> The mean health status area under the curve was 0.807 (standard deviation 0.205) in the flexible ureteroscopic stone treatment group (<jats:italic>n<\/jats:italic>\u00a0=\u00a0164) and 0.826 (standard deviation 0.207) in the shockwave lithotripsy group (<jats:italic>n<\/jats:italic>\u00a0=\u00a0188). The between-group difference, 0.024 (95% confidence interval \u22120.004 to 0.053), was a small difference in favour of flexible ureteroscopic stone treatment after correcting for a baseline imbalance. Complete stone clearance was higher with flexible ureteroscopic stone treatment (72%) than shockwave lithotripsy (36%).<\/jats:p>\n<jats:p><jats:italic>RCT2<\/jats:italic>: The mean health status area under the curve was 0.794 (standard deviation 0.198) in the flexible ureteroscopic stone treatment group (<jats:italic>n<\/jats:italic>\u00a0=\u00a057) and 0.818 (standard deviation 0.217) in the keyhole surgery group (<jats:italic>n<\/jats:italic>\u00a0=\u00a063). The between-group difference, \u22120.07 (95% confidence interval \u22120.11 to \u22120.02), was a borderline meaningful difference favouring keyhole surgery. Complete stone clearance was higher with keyhole surgery (71%) than flexible ureteroscopic stone treatment (48%).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Economic evaluation<\/jats:title>\n<jats:p><jats:italic>RCT1<\/jats:italic>: Flexible ureteroscopic stone treatment is more costly (\u00a31138; 95% confidence interval \u00a3646 to \u00a31631) and produces 0.017 (95% confidence interval \u22120.008 to 0.043) additional quality-adjusted life-years; with an incremental cost-effectiveness ratio of \u00a365,163 per quality-adjusted life-year gained. Shockwave lithotripsy has a 99.9% chance of being cost-effective at a \u00a320,000 threshold value.<\/jats:p>\n<jats:p><jats:italic>RCT2<\/jats:italic>: Flexible ureteroscopic stone treatment is more costly (\u00a3733; 95% confidence interval \u2212\u00a3508 to \u00a31973) and produces fewer quality-adjusted life-years (\u22120.001; 95% confidence interval \u22120.044 to 0.042). Keyhole surgery has an 87% chance of being cost-effective at a \u00a320,000 threshold value.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Limitations<\/jats:title>\n<jats:p>Blinding of participants and healthcare providers was not possible. There were differential waiting times between interventions in RCT1; however, adjusting for this gave similar treatment effect estimates.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Conclusions<\/jats:title>\n<jats:p>The PUrE study found in RCT1 that shockwave lithotripsy was more cost-effective than flexible ureteroscopic stone treatment, with no meaningful difference in patient health status even though complete stone-free rates were higher with flexible ureteroscopic stone treatment. In RCT2, keyhole surgery was more cost-effective than flexible ureteroscopic stone treatment on a micro-costing basis, which better reflects treatment cost differences to the NHS. Keyhole surgery was marginally beneficial for health status with higher complete stone-free rates.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Future work<\/jats:title>\n<jats:p>What effect will suction devices, improvements in laser technology, and intraoperative pressure monitoring have on postoperative pain, quality of life, stone-free rates, complications, and costs of flexible ureteroscopic stone treatment?<\/jats:p>\n<jats:p>What effect does miniaturisation of keyhole surgery have on postoperative pain, length of stay, complications, stone-free rates and costs?<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-14\"><jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered as ISRCTN98970319.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-15\"><jats:title>Funding<\/jats:title>\n<jats:p>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13\/152\/02) and is published in full in <jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 29, No. 40. See the NIHR Funding and Awards website for further award information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/wfre6844","type":"journal-article","created":{"date-parts":[[2024,3,7]],"date-time":"2024-03-07T05:44:03Z","timestamp":1709790243000},"page":"1-186","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical and cost-effectiveness of percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole stones: the PUrE RCTs"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8039-6903","authenticated-orcid":true,"given":"Oliver","family":"Wiseman","sequence":"first","affiliation":[{"name":"Department of Urology, Addenbrooke\u2019s Hospital, Cambridge University Hospitals NHS Trust, Cambridge, 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