The PUrE RCT: The clinical and cost-effectiveness of surgical interventions for stones in the lower pole calyces of the kidney
Kidney stone disease is very common and, although stones in the kidney do not always cause problems, most need treatment. They can cause serious problems, such as pain, infection and kidney failure, with burden to patients, the NHS and society. There are three treatment options in the NHS for stones in the lower part of the kidney: (1) flexible ureterorenoscopy with laser lithotripsy (FURS); (2) percutaneous nephrolithotomy (PNL); and (3) extracorporeal shockwave lithotripsy (ESWL). Each treatment has advantages and disadvantages (benefits and harms) and there is uncertainty about which of these treatments is best to free people from kidney stones and which is best value for patients and the NHS.
This study will randomly allocate 522 patients with smaller stones (diameter ≤ 10 mm) to be treated with either FURS or ESWL and 522 patients with larger stones (10 mm < diameter ≤ 25 mm ) to be treated with either FURS or PNL, with each participant followed up for one year.
The primary outcome is generic health status (EQ-5D-5L) area under the curve (AUC) to 12 weeks post-intervention. This study includes a full economic evaluation. A within trial analysis as well as a simple model to extend the analysis beyond the clinical study follow-up period will be considered. For further details please see: http://www.nets.nihr.ac.uk/projects/hta/1315202.
HERU researchers involved in this research project: Rodolfo Hernández
External collaborators: S McClinton (NHS Grampian & University of Aberdeen); T Lam (University of Aberdeen); O Wiseman (Addenbrooke's NHS Trust); D Smith (University College London Hospital); B Turney (John Radcliffe Hospital NHS Trust); R Pickard (The Freeman Hospital & University of Newcastle); R Thomas, G MacLennan, J Norrie, S MacLennan, K Starr, CT Clark (HSRU, University of Aberdeen) and K Anson (St George's Healthcare NHS Trust)
McClinton, S., Starr, K., Thomas, R., MacLennan, G., Lam, T., Hernández, R., Pickard, R., Anson, K., Clark, T., MacLennan, S., Thomas, D., Smith, D., Turney, B., McDonald, A., Cameron, S. and Wiseman, O. (2020) 'The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol', Trials, 21(1), 479.