Abstract
INTRODUCTION: Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones.
METHODS: The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation.
DISCUSSION: The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.
TRIAL REGISTRATION: ISRCTN: ISRCTN98970319. Registered on 11 November 2015.
| Original language | English |
|---|---|
| Article number | 479 |
| Number of pages | 15 |
| Journal | Trials |
| Volume | 21 |
| DOIs | |
| Publication status | Published - 4 Jun 2020 |
Bibliographical note
PUrE is a UK Collaborative Trial funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project no. 13/152/02). The Health Services Research Unit is funded by the Chief Scientists Office of the Scottish Government Health Directorates. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, the National Institute of Health Research, the National Health Service or the Department of Health. The funder (through their peer-review and funding board review process) approved the study proposal but had no role in the collection, analysis or interpretation of data or writing of the report.Keywords
- renal stone
- lower pole stone
- percutaneous nephrolithotomy
- flexible ureterorenoscopy
- extracorporeal shock wave lithotripsy
- Renal stone
- Percutaneous nephrolithotomy
- Flexible ureterorenoscopy
- Lower pole stone
- Extracorporeal shockwave lithotripsy
- NATURAL-HISTORY
- RETROGRADE INTRARENAL SURGERY
- FRAGMENTS
- URETEROSCOPIC MANAGEMENT
- DISEASE
- RENAL-CALCULI
- WAVE LITHOTRIPSY
- NEPHROSTOLITHOTOMY
Access to Document
- McClinton_etal_Trials_Clinical_and_cost_VOR
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