PUrE: percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones
| ISRCTN | ISRCTN98970319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98970319 |
| EudraCT/CTIS number | 2014-002751-25 |
| IRAS number | 188563 |
| Secondary identifying numbers | HTA 13/152/02, IRAS 188563 |
- Submission date
- 11/11/2015
- Registration date
- 11/11/2015
- Last edited
- 14/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Kidney stones are stone-like lumps that can develop in one or both of the kidneys. Although some stones do not cause pain or discomfort, patients can develop serious pain, infection, blood in urine, kidney problems or even kidney failure. Many stones occur in the lower part of the kidney (lower pole stones). These stones are more likely to require treatment because they are less likely to pass on their own. Currently within the NHS there are three treatment options for lower kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PNL), and flexible ureterorenoscopy with laser lithotripsy (FURS). We are uncertain which of these treatments is best at getting rid of stones and which is best value for patients and the NHS. They each have advantages and disadvantages (benefits and harms). The aim of this study is to determine the clinical effectiveness and cost effectiveness of these three treatment options for lower kidney stones.
Who can participate?
Patients aged 16 or over with lower pole kidney stones.
What does the study involve?
Patients with smaller stones are randomly allocated to be treated with either FURS or ESWL. Patients with larger stones are randomly allocated to be treated with either FURS or PCNL. In FURS, a small telescope is passed into the bladder through the urethra and up to the kidney, and a laser beam breaks the stone into pieces, which are then either retrieved or the passed spontaneously after the procedure. In ESWL, shockwaves from a machine outside the body target and break the stone into pieces, which are then passed spontaneously. In PCNL, a hole is made in the skin, a tube is inserted through it into the kidney, and a small telescope is inserted into the kidney via the tube to break the stone and remove all the pieces.
What are the possible benefits and risks of participating?
Patients undergoing FURS require an anaesthetic and sometimes a hospital stay, and there is a small risk of complications (e.g., infection, bleeding). ESWL does not need an anaesthetic nor hospital stay, but passing the pieces can take time, more than one treatment may be needed for larger stones, and some pieces may not pass at all. PCNL usually clears the stone completely in one go, but needs an anaesthetic, hospital stay, and may cause more serious problems (bleeding and infection). We think FURS may clear the stone more efficiently than ESWL, but less well than PNL.
Where is the study run from?
Aberdeen Royal Infirmary (UK) and 48 hospitals across the UK (as of 29/10/2018)
When is the study starting and how long is it expected to run for?
May 2015 to February 2023
Who is funding the study?
National Institute for Health Research Technology Assessment Programme (NIHR HTA) (UK).
Who is the main contact?
Dawn McRae, pure@abdn.ac.uk
Contact information
Scientific
NHS Grampian
Department of Urology
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
Public
PUrE Trial Office
Centre for Healthcare Randomised Trials (CHaRT)
3rd Floor Health Sciences Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| Phone | +44 1224 438112 |
|---|---|
| pure@abdn.ac.uk |
Study information
| Study design | Two separate pragmatic multicentre patient-randomised open-label superiority randomised controlled trials with an initial internal pilot phase |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) |
| Study acronym | PUrE |
| Study hypothesis | The null hypotheses being tested are: 1. The use of flexible urterorenoscopy with laser lithotripsy (FURS) to treat lower pole kidney stones less than 10 mm will not be superior to extracorporeal shockwave lithotripsy (ESWL) as assessed by a relative increase of at least 0.3 of a standard deviation (SD) on the EQ-5D AUC up to 12 weeks post treatment 2. The use of FURS to treat lower pole stones of the kidney 10 mm or greater and less than or equal to 25 mm will not be superior to percutaneous nephrolithotomy (PCNL) by an increase of 0.3SD on the EQ-5D AUC up to 12 weeks post treatment. Further information can be found at: http://www.nets.nihr.ac.uk/projects/hta/1315202 |
| Ethics approval(s) | North of Scotland Research Ethics Committee, 10/11/2015, REC ref: 15/NS/0113 |
| Condition | Lower pole kidney stones |
| Intervention | RCT 1: FURS versus ESWL for stone sizes <=10 mm RCT 2: FURS versus PCNL for stone sizes >10mm <=25 mm FURS A flexible ureteroscope is passed into the kidney and a holmium laser fibre used to fragment stones. Stone fragments are then either retrieved or the patient passes them spontaneously after the procedure. PCNL A small incision is made in the skin through which a tube is inserted into the kidney. A nephroscope is inserted via this tube to retrieve the stone, or fragment it before retrieval. The intention is to remove all stone fragments. ESWL An external acoustic pulse (shockwave), from outside the body is focused onto the kidney stone, causing it to fragment. Stone fragments are then passed spontaneously by the patient in the days following the treatment. It may be delivered by fixed (static, on-site) or mobile (external) machines. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Patient-reported: Health status (EQ-5D-5L) area under the curve (AUC) to 12 weeks post intervention, based upon EQ-5D completion at fixed time points; at baseline (recruitment), just prior to initial intervention (FURS, PCNL or first session of ESWL), at 1, 2, 4, 8, and 12 weeks after initial intervention, and at variable time points; just prior and 1 week after any additional intervention (including planned additional ESWL sessions and removal of stent) and once during hospitalisation for adverse events related to treatment (e.g. pain and infection). 2. Economic: Incremental cost per quality adjusted life year (QALYs) gained at 12 months post-randomisation based on the estimated NHS costs and participant responses to the EQ-5D (including additional time point at 12 months). |
| Secondary outcome measures | 1. Patient reported: 1.1. Severity of pain as measured by the Numeric Rating scale (NRS; completed with EQ-5D-5L) 1.2. Generic health profile as measured by the SF-12 (completed at baseline and 12 months) 1.3. Use of analgesia (completed with NRS and EQ-5D) 2. Clinical: 2.1. Stone clearance measured at between 8 and 12 weeks post initial intervention using renal imaging (CTKUB preferred but plain x-ray and ultrasound acceptable). Measured by local trial staff and categorized as complete, acceptable, or unacceptable. Also maximum dimension of the largest fragment of the treated stone in mm 2.2. Need for additional treatment (carried out or planned) at 12 weeks post-initial treatment and 12 months post randomisation 2.3. Complications during initial intervention. Intervention-related complications at 12 weeks (categorised by Clavien-Dindo classification) post treatment and up to 12 months post randomisation. All measured by site staff and entered on CRF. 3. Economic: 3.1. NHS primary and secondary care resources used and their costs 3.2. Patient costs (out of pocket), time off work up to 12 months post randomisation Data gathered from completion of CRFs by site staff and participant questionnaire at 12 weeks post initial treatment and 12 months post randomisation. |
| Overall study start date | 01/12/2015 |
| Overall study end date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1044 (522 in each RCT) |
| Total final enrolment | 625 |
| Participant inclusion criteria | 1. Adults ≥16 years of age 2. Lower pole stone ≤25 mm in maximum dimension with decision to treat that stone 3. Presence of stone confirmed by CTKUB 4. Able and willing to undergo either treatment for specified stone size 5. Capacity to give informed consent to participate in trial which includes adherence to trial requirements |
| Participant exclusion criteria | 1. Pregnancy 2. Patients with co-existing stone that takes precedence in deciding treatment modality (such as obstructing ureteric stone or large upper pole stone) 3. Patients with health or other factors that are absolute contraindications to an intervention that they may be allocated 4. Patients unable to understand or complete trial documentation |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 31/03/2021 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Ward 44
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
Norwich
NR4 7UY
United Kingdom
Wakefield
WF1 4DG
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Southampton
SO16 6YD
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
London
W6 8RF
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Upton
Birkenhead
Wirral
CH49 5PE
United Kingdom
Middlesborough
TS4 3BW
United Kingdom
Sheffield
S10 2JF
United Kingdom
Manchester
OL1 2JH
United Kingdom
Belfast
BT9 7AB
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Leeds
LS9 7TF
United Kingdom
Manchester
M13 9WL
United Kingdom
Salford
M6 8HD
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
Southport
PR8 6PN
United Kingdom
Canterbury
CT1 3NG
United Kingdom
Warrington Road
Rainhill
Prescot
L35 5DR
United Kingdom
Liverpool
L14 3LB
United Kingdom
Epsom
KT18 7EG
United Kingdom
Dartford
DA2 8DA
United Kingdom
Rotherham
S60 2UD
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
London
SW17 0RE
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Romford
RM1 4HL
United Kingdom
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Coventry
CV2 2DX
United Kingdom
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
London Road
Ashford
TW15 3AA
United Kingdom
Exeter
EX2 5DW
United Kingdom
Craven Road
Reading
RG1 5AN
United Kingdom
Truro
TR1 3LJ
United Kingdom
Leicester
LE5 4PW
United Kingdom
Sponsor information
University/education
Research and Innovation
King's College
Regent Walk
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Phone | +44 (0)1224 272 123 |
|---|---|
| res-innov@abdn.ac.uk | |
| Website | https://www.abdn.ac.uk/business-info/research-innovation/ |
Hospital/treatment centre
Research and Development Office
Foresterhill Annexe
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
| Phone | +44 (0)1224 553 846 |
|---|---|
| grampian.randdpermissions@nhs.net |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/06/2020 | 08/06/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/11/2022: The following changes have been made:
1. The overall trial end date was changed from 31/10/2021 to 28/02/2023.
2. The intention to publish date was changed from 31/10/2022 to 31/07/2023.
3. Total final enrolment and IRAS number added.
27/11/2020: The following changes have been made:
1. The public contact has been changed and the plain English summary updated accordingly.
2. The recruitment end date has been changed from 30/09/2020 to 31/03/2021.
3. Recruitment has resumed.
08/06/2020: Publication reference added.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused as of 16/03/2020.
12/12/2019: The EudraCT number was added.
03/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/06/2019 to 30/09/2020.
2. The overall end date was changed from 01/12/2020 to 31/10/2021.
3. The intention to publish date was changed from 01/06/2021 to 31/10/2022.
4. The plain English summary was updated to reflect these changes.
08/04/2019: The recruitment end date was changed from 01/03/2019 to 28/06/2019.
29/10/2018: The following changes have been made to the trial record:
1. Kath Starr was added as a study contact.
2. Western Sussex Hospitals, Bradford Teaching Hospitals NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Ashford & St. Peter's Hospitals NHS Foundation Trust, Royal Devon & Exeter NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, Royal Cornwall Hospitals NHS Trust and University Hospitals of Leicester NHS Trust have been added as trial participating centres.
3. The plain English summary has been updated to reflect the 48 new trial participating centres.
25/10/2018: Norfolk and Norwich University Hospital, Pinderfields Hospital, Freeman Hospital, Addenbrooke's Hospital, Broomfield Hospital, Royal Blackburn Hospital, Southampton General Hospital, Southmead Hospital, Churchill Hospital, Charing Cross Hospital, Raigmore Hospital, Arrowe Park Hospital, James Cook University Hospital, Royal Hallamshire Hospital, Royal Oldham Hospital, Belfast City Hospital, Wrexham Maelor Hospital, Derriford Hospital, St James's University Hospital, Manchester Royal Infirmary, Salford Royal Hospital, Royal Bournemouth Hospital, Sunderland Royal Hospital, Kingston Hospital, Wythenshawe Hospital, Stockport NHS Foundation Trust, Eastbourne District General Hospital, Western General Hospital, Southport & Formby District General Hospital, Kent and Canterbury Hospital, St Helens and Knowsley Teaching Hospitals, Broadgreen Hospital, Epsom General Hospital, Dartford and Gravesham NHS Trust, Rotherham NHS Foundation Trust, Royal Sussex County Hospital, St George's University of London, Northwick Park Hospital, Victoria Hospital, Gloucestershire Hospitals NHS Foundation Trust and University Hospitals Coventry & Warwickshire were added as trial participating centres.
