Dasgupta R. et al., 2021: Shockwave Lithotripsy Versus Ureteroscopic Treatment as Therapeutic Interventions for Stones of the Ureter (TISU): A Multicentre Randomised Controlled Non-inferiority Trial
Dasgupta R, Cameron S, Aucott L, MacLennan G, Thomas RE, N'Dow J, Norrie J, Anson K, Keeley FX Jr, MacLennan SJ, Starr K, McClinton S.
Department of Urology, Imperial College Healthcare NHS Trust, London, W2 1NY, UK.
Centre for Healthcare Randomised Trials, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.
Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.
NHS Grampian, Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK.
Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.
Department of Urology, St Georges University Hospitals NHS Foundation Trust, London, UK.
Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.
Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.
Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, UK.
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
Eur Urol. 2021 Mar 30:S0302-2838(21)00171-8. doi: 10.1016/j.eururo.2021.02.044. Online ahead of print. PMID: 33810921.
Comments 1
Numerous studies comparing SWL, and URS have been published and in most of them the conclusion is that ureteroscopic stone removal is associated with superior stone-free rates and therefore should be the preferred treatment.
In this multicentre randomized comparison of the two procedures the authors concluded that although the need of additional stone clearing procedures was lower following URS (10.3%) than following SWL (22.1%), the difference between the two treatment modalities was marginal. For patients who passed the stones before intervention, the corresponding percentages were 26 and 12. To decide that SWL is inferior to URS required a difference of >20%! Accordingly, it was obvious that SWL was not inferior to URS for treatment of stones in the distal ureter.
There are some other notable observations in this large, randomized study:
1. The waiting time for treatment was longer for URS than for SWL.
2. URS had a marginally better treatment outcome but that was compensated for by lower health care cost.
3. The great advantage of SWL was that it was possible to complete the treatment without general anaesthesia, in an outpatient setting and without access to an operating theatre
During recent years different reports have applauded the superior results of URS compared with SWL. In view of that it is reassuring that in this exceptionally large multicentre comparison between the two methods the bottom-line is that SWL was non-inferior to URS. Accordingly, SWL is a useful and valuable option for removal of ureteral stones.
This article is recommended reading for all urologists who want to treat their patients in an effective, low-invasive and economic way.
Hans-Göran Tiselius