Shockwave Lithotripsy Versus Ureteroscopic Treatment as Therapeutic Interventions for Stones of the Ureter (TISU): A Multicentre Randomised Controlled Non-inferiority Trial

Ranan Dasgupta* (Corresponding Author), Sarah Cameron, Lorna Aucott, Graeme MacLennan, Ruth Thomas, James N'Dow, John Norrie, Ken Anson, Francis X. Keeley Jr, Sara MacLennan, Kathryn Starr, Sam McClinton, Mary Kilonzo, Thomas Lam

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

19 Citations (Scopus)

Abstract

Background
Renal stone disease is common and can cause emergency presentation with acute pain due to ureteric colic. International guidelines have stated the need for a multicentre randomised controlled trial (RCT) to determine whether a non-invasive outpatient (shockwave lithotripsy [SWL]) or surgical (ureteroscopy [URS]) intervention should be the first-line treatment for those needing active intervention. This has implications for shaping clinical pathways.

Objective
To report a pragmatic multicentre non-inferiority RCT comparing SWL with URS.

Design, setting, and participants
This trial tested for non-inferiority of up to two sessions of SWL compared with URS as initial treatment for ureteric stones requiring intervention.

Outcome measurements and statistical analysis
The primary outcome was whether further intervention was required to clear the stone, and secondary outcomes included quality of life assessment, severity of pain, and serious complications; these were based on questionnaires at baseline, 8 wk, and 6 mo. We included patients over 16 yr with a single ureteric stone clinically deemed to require intervention. Intention-to-treat and per-protocol analyses were planned.

Results and limitations
The study recruited between July 1, 2013 and June 30, 2017. We recruited 613 participants from a total of 1291 eligible patients, randomising 306 to SWL and 307 to URS. Sixty-seven patients (22.1%) in the SWL arm needed further treatment compared with 31 patients (10.3%) in the URS arm. The absolute risk difference was 11.7% (95% confidence interval 5.6%, 17.8%) in favour of URS, which was inside the 20% threshold we set for demonstrating noninferiority of SWL.

Conclusions
This RCT was designed to test whether SWL is non-inferior to URS and confirmed this; although SWL is an outpatient noninvasive treatment with potential advantages both for patients and for reducing the use of inpatient health care resources, the trial showed a benefit in overall clinical outcomes with URS compared with SWL, reflecting contemporary practice. The Therapeutic Interventions for Stones of the Ureter (TISU) study provides new evidence to help guide the choice of modality for this common health condition.

Patient summary
We present the largest trial comparing ureteroscopy versus extracorporeal shockwave lithotripsy for ureteric stones. While ureteroscopy had marginally improved outcome in terms of stone clearance, as expected, shockwave lithotripsy had better results in terms of health care costs. These results should enable patients and health care providers to optimise treatment pathways for this common urological condition.
Original languageEnglish
Pages (from-to)46-54
Number of pages9
JournalEuropean Urology
Volume80
Issue number1
Early online date31 Mar 2021
DOIs
Publication statusPublished - 1 Jul 2021

Bibliographical note

Funding/Support and role of the sponsor: This paper presents independent research funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme, Project Number 10/137/01. The views and opinions expressed in this report are those of the authors and do not necessarily reflect those of the HTA Programme, the NIHR, the NHS, or the Department of Health. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates; however, the opinions expressed in this publication are those of the authors and might not be shared by the Chief Scientist Office.

Acknowledgements: Special thanks must go to all of the TISU trial participants and staff at each of our recruiting centres for taking part in this trial. We thank our collaborators at the TISU sites, and participating National Health Service (NHS) trusts and boards (the Newcastle upon Tyne Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, City Hospitals Sunderland NHS Foundation Trust, the Leeds Teaching Hospitals NHS Trust, University Hospitals Bristol NHS Trust, NHS Lothian, Guy’s and St Thomas’ NHS Foundation Trust, St George’s Healthcare NHS Trust, Mid Yorkshire Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Central Manchester University Hospitals NHS Foundation Trust, Betsi Cadwaladr University Health Board, Dartford and Gravesham NHS Trust, St Helens & Knowsley Teaching Hospital NHS Trust, Ashford & St Peters Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Northwest London Hospital NHS Trust, Mid-Essex Hospital NHS Trust, Salford Royal NHS Foundation Trust, Oxford University Hospitals Trust, East Kent Hospitals University NHS Foundation Trust, Hull and East Yorkshire Hospitals NHS Trust, Derby Hospital NHS Foundation trust, Bradford Teaching Hospitals NHS Foundation Trust, and the University Hospital of South Manchester NHS Foundation Trust). We thank the staff at the TISU trial office based in the Centre for Healthcare Randomised Trials (CHaRT) within the Health Services Research Unit, University of Aberdeen.

Data Availability Statement

Supplementary material related to this article can be
found, in the online version, at doi:https://doi.org/10.1016/j.
eururo.2021.02.044.

Keywords

  • Therapeutic interventions for symptomatic ureteric stones
  • Ureteric stones
  • Ureteroscopy
  • Extracorporeal shockwave lithotripsy
  • Trial
  • Randomised controlled trial

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