TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones

study protocol for a randomised controlled trial

Samuel McClinton, Sarah Cameron, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Alison McDonald, Thomas Lam, James N’Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Neil Burgess, Charles Terry Clark, Sara MacLennan, John Norrie, the TISU Study Group

Research output: Contribution to journalArticle

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6 Downloads (Pure)

Abstract

Background
Urinary stone disease is very common with an estimated prevalence among the general population of 2–3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients’ quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention.

The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden).

The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option.

Methods
The TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones.

Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation.

Discussion
Determining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally.

Trial registration
ISRCTN registry, ISRCTN92289221. Registered on 21 February 2013.
Original languageEnglish
Article number286
Pages (from-to)1-11
Number of pages11
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 22 May 2018

Fingerprint

Lithotripsy
Randomized Controlled Trials
Costs and Cost Analysis
Ureteroscopy
Random Allocation
Therapeutics
Economics
Pain
Aptitude
Quality-Adjusted Life Years
Ureter
Urinary Tract
Health Personnel
Uncertainty
Registries
Anesthetics
Urinary Bladder
Hospitalization
Tomography
Quality of Life

Keywords

  • Ureteric stone
  • ESWL
  • Ureteroscopy

Cite this

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones : study protocol for a randomised controlled trial. / McClinton, Samuel; Cameron, Sarah; Starr, Kathryn; Thomas, Ruth; MacLennan, Graeme; McDonald, Alison; Lam, Thomas; N’Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Burgess, Neil; Clark, Charles Terry; MacLennan, Sara; Norrie, John; the TISU Study Group.

In: Trials, Vol. 19, No. 1, 286, 22.05.2018, p. 1-11.

Research output: Contribution to journalArticle

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abstract = "BackgroundUrinary stone disease is very common with an estimated prevalence among the general population of 2–3{\%}. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients’ quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention.The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden).The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option.MethodsThe TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones.Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation.DiscussionDetermining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally.Trial registrationISRCTN registry, ISRCTN92289221. Registered on 21 February 2013.",
keywords = "Ureteric stone, ESWL, Ureteroscopy",
author = "Samuel McClinton and Sarah Cameron and Kathryn Starr and Ruth Thomas and Graeme MacLennan and Alison McDonald and Thomas Lam and James N’Dow and Mary Kilonzo and Robert Pickard and Ken Anson and Frank Keeley and Neil Burgess and Clark, {Charles Terry} and Sara MacLennan and John Norrie and {the TISU Study Group}",
note = "This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 10/137/01) and will be published in full in Health Technology Assessment. The Health Services Research Unit of the University of Aberdeen iscore funded by the Chief Scientist Office (CSO) of the Scottish Government Health and Social Care Directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the CSO, HTA programme, NIHR, NHS or the Department of Health.",
year = "2018",
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T1 - TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones

T2 - study protocol for a randomised controlled trial

AU - McClinton, Samuel

AU - Cameron, Sarah

AU - Starr, Kathryn

AU - Thomas, Ruth

AU - MacLennan, Graeme

AU - McDonald, Alison

AU - Lam, Thomas

AU - N’Dow, James

AU - Kilonzo, Mary

AU - Pickard, Robert

AU - Anson, Ken

AU - Keeley, Frank

AU - Burgess, Neil

AU - Clark, Charles Terry

AU - MacLennan, Sara

AU - Norrie, John

AU - the TISU Study Group

N1 - This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 10/137/01) and will be published in full in Health Technology Assessment. The Health Services Research Unit of the University of Aberdeen iscore funded by the Chief Scientist Office (CSO) of the Scottish Government Health and Social Care Directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the CSO, HTA programme, NIHR, NHS or the Department of Health.

PY - 2018/5/22

Y1 - 2018/5/22

N2 - BackgroundUrinary stone disease is very common with an estimated prevalence among the general population of 2–3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients’ quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention.The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden).The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option.MethodsThe TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones.Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation.DiscussionDetermining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally.Trial registrationISRCTN registry, ISRCTN92289221. Registered on 21 February 2013.

AB - BackgroundUrinary stone disease is very common with an estimated prevalence among the general population of 2–3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients’ quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention.The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden).The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option.MethodsThe TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones.Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation.DiscussionDetermining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally.Trial registrationISRCTN registry, ISRCTN92289221. Registered on 21 February 2013.

KW - Ureteric stone

KW - ESWL

KW - Ureteroscopy

U2 - 10.1186/s13063-018-2652-1

DO - 10.1186/s13063-018-2652-1

M3 - Article

VL - 19

SP - 1

EP - 11

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 286

ER -