Condition category
Urological and Genital Diseases
Date applied
11/11/2015
Date assigned
11/11/2015
Last edited
27/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 October 2021 (updated 03/07/2019, previously: December 2020).

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

Trial website

https://w3.abdn.ac.uk/hsru/PUrE/

Contact information

Type

Scientific

Primary contact

Prof Samuel McClinton

ORCID ID

Contact details

NHS Grampian
Department of Urology
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom

Type

Public

Additional contact

Ms Dawn McRae

ORCID ID

Contact details

PUrE Trial Office
Centre for Healthcare Randomised Trials (CHaRT)
3rd Floor Health Sciences Building
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
01224 438112
pure@abdn.ac.uk

Additional identifiers

EudraCT number

2014-002751-25

ClinicalTrials.gov number

Nil known

Protocol/serial number

HTA 13/152/02

Study information

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)

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

North of Scotland Research Ethics Committee, 10/11/2015, REC ref: 15/NS/0113

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

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 trial start date

01/12/2015

Overall trial end date

31/10/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

1044 (522 in each RCT)

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

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Department of Urology Ward 44 Foresterhill
Aberdeen
AB25 2ZB
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Broomfield Hospital
Court Road Broomfield
Chelmsford
CM1 7ET
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Southmead Hospital
Dorian Way Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Churchill Hospital
Old Road Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Trial participating centre

Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
United Kingdom

Trial participating centre

Arrowe Park Hospital
Arrowe Park Road Upton Birkenhead
Wirral
CH49 5PE
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Road
Middlesborough
TS4 3BW
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Royal Oldham Hospital
Rochdale Road
Manchester
OL1 2JH
United Kingdom

Trial participating centre

Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Grafton Street
Manchester
M13 9WL
United Kingdom

Trial participating centre

Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Royal Bournemouth Hospital
Castle Lane E
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Kingston Hospital
Galsworthy Road
Kingston upon Thames
KT2 7QB
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
Stepping Hill Hospital Poplar Grove Hazel Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Eastbourne District General Hospital
King's Drive
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Western General Hospital
Department of Urology Western General Hospital Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Southport & Formby District General Hospital
Town Lane
Southport
PR8 6PN
United Kingdom

Trial participating centre

Kent and Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Trial participating centre

St Helens and Knowsley Teaching Hospitals
Whiston Hospital Warrington Road Rainhill
Prescot
L35 5DR
United Kingdom

Trial participating centre

Broadgreen Hospital
Thomas Drive
Liverpool
L14 3LB
United Kingdom

Trial participating centre

Epsom General Hospital
Dorking Road
Epsom
KT18 7EG
United Kingdom

Trial participating centre

Dartford and Gravesham NHS Trust
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom

Trial participating centre

Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Barry Building Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

St George's, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Trial participating centre

Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Trial participating centre

Victoria Hospital
Pettits Lane
Romford
RM1 4HL
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Alexandra House Cheltenham General Hospital Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

University Hospitals Coventry & Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Western Sussex Hospitals
Western Sussex Hospitals NHS Foundation Trust Spitalfield Lane
Chichester
PO19 6SE
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Blackpool Teaching Hospitals NHS Foundation Trust
Trust Headquarters Blackpool Victoria Hospital Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

Ashford & St. Peter's Hospitals NHS Foundation Trust
Ashford Hospital London Road
Ashford
TW15 3AA
United Kingdom

Trial participating centre

Royal Devon & Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
London Road Craven Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Penventinnie Lane
Truro
TR1 3LJ
United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

Research and Innovation
King's College
Regent Walk
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 272 123
res-innov@abdn.ac.uk

Sponsor type

University/education

Website

https://www.abdn.ac.uk/business-info/research-innovation/

Organisation

Grampian Health Board (UK)

Sponsor details

Research and Development Office
Foresterhill Annexe
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553 846
grampian.randdpermissions@nhs.net

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research Technology Assessment Programme (NIHR HTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

31/10/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32498699/ (added 08/06/2020)

Publication citations

Additional files

Editorial Notes

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.