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. 2018 May 22;19(1):286.
doi: 10.1186/s13063-018-2652-1.

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  1   2 , Sarah Cameron  3   4 , Kathryn Starr  2   5 , Ruth Thomas  5 , Graeme MacLennan  5 , Alison McDonald  5 , Thomas Lam  1   2 , James N'Dow  1   2 , Mary Kilonzo  6 , Robert Pickard  7 , Ken Anson  8 , Frank Keeley  9 , Neil Burgess  10 , Charles Terry Clark  11 , Sara MacLennan  2 , John Norrie  12 ; TISU Study Group
Affiliations

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 et al. Trials. .

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.

Keywords: ESWL; Ureteric stone; Ureteroscopy.

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Conflict of interest statement

Ethics approval and consent to participate

The North of Scotland Research Ethics Committee 2 has reviewed and approved this study for all the UK centres involved (ref- 13/NS/0002). The study has been conducted according to the Principles of Good Practice provided by Research Governance Guidelines. We believe this study does not pose any specific risks to individual participants beyond those of any ureteric stone treatment, nor does it raise any extraordinary ethical issues. Annual progress reports and a final report at the conclusion of the trial will be submitted to North of Scotland REC within the timelines defined in the regulations. Written informed consent was obtained from all participants in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram. Randomised controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with ureteroscopic retrieval as first treatment options for urinary stones
Fig. 2
Fig. 2
PRECIS-2 wheel for the TISU trial
Fig. 3
Fig. 3
Schedule of enrolment, interventions and assessments
See this image and copyright information in PMC

References

    1. Menon M, Parulkar BG, Drach GW. Urinary lithiasis: etiology, diagnosis and medical management. In: Walsh PC, Retnik AB, Vaughan ED, Wein AJ, editors. Campbell's Urology. 7th ed. Philadelphia: WB Saunders Company; 1998. p. 2659–2752.
    1. Bihl G, Meyers A. Recurrent renal stone disease-advances in pathogenesis and clinical management. Lancet. 2001;358:651–656. doi: 10.1016/S0140-6736(01)05782-8. - DOI - PubMed
    1. Wilkinson H. Clinical investigation and management of patients with renal stones. Ann Clin Biochem. 2001;38:3–7. doi: 10.1258/0004563011900623. - DOI - PubMed
    1. Stamatelou KK, Francis ME, Jones CA, Nyberg LM, Jr, Curhan GC. Time trends in reported prevalence of kidney stones in the United States: 1976-1994. Kidney Int. 2003;63:1817–1823. doi: 10.1046/j.1523-1755.2003.00917.x. - DOI - PubMed
    1. Hospital Episode Statistics, Admitted Patient Care - England, 2011–12: Primary Diagnosis 3 characters table. NHS 2012. https://digital.nhs.uk/data-and-information/publications/statistical/hos.... Accessed Nov 2016.

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