TISU: Therapeutic Interventions for Stones of the Ureter: a multicentre randomised controlled trial of extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic retrieval, for ureteric stones
Urinary stone disease is very common with an estimated prevalence among the general population of 2–3% (1.8 million people in the UK) with males forming stones three times as often as females. All symptomatic urinary tract stones, and ureteric stones in particular, are associated with severe pain and can have a significant impact on patients’ quality of life due to the detrimental effect on their ability to work and the need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care (painkillers and fluids) possibly aided by drugs such as alpha blockers or calcium channel blockers (conservative management). However, between a fifth and a third of cases require an active intervention (stone removal) because of failure to pass the stone, continuing pain, infection or obstruction to urine drainage.
The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. Whilst both ESWL and ureteroscopy appear to be effective in terms of stone clearance they differ in terms of invasiveness, anaesthetic requirement, treatment setting, potentially the number of procedures required to clear the stone, complications, patient reported outcomes (such as severity and duration of pain after intervention, time off work and bothersome urinary symptoms), 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).
Outcome and Translation
The findings of this project will inform the decision makers on the most clinical and cost- effective surgical intervention to use in the treatment of ureteric stones. The project will also inform the national guidance on the treatment of patients that present with ureteric stones.
ISRCTN registry: ISRCTN92289221
TISU Project website (Centre for Healthcare Randomised Trials)
HERU researchers involved in this research project: Mary Kilonzo
External collaborators: S McClinton, L Kurban (NHS Grampian); J N’Dow, S MacLennan, T Lam (Academic Urology Unit, University of Aberdeen); G MacLennan, J Norrie, R Thomas, K Starr (HSRU, University of Aberdeen); F Keely (Southmead Hospital); K Anson (St Georges NHS Trust); C Clark (Service User); R Pickard (Newcastle University) and N Burgess (Norfolk and Norwich University Hospital)
McClinton, S., Cameron, S., Starr, K., Thomas, R., MacLennan, G., McDonald, A., Lam, T., N'Dow, J., Kilonzo, M., Pickard, R., Anson, K., Keeley, F., Burgess, N., Clark, C.T., MacLennan, S. and Norrie, J. (2018) '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' [Protocol], Trials, 19(1), 286.
Dasgupta, R., Cameron, S., Aucott, L., MacLennan, G., Kilonzo, M., Lam, T., Thomas, R., Norrie, J., McDonald, A., Anson, K., N'Dow, J., Burgess, N., Clark, C., Keeley, F., MacLennan, S., Starr, K. and McClinton, S. (2019) A multicentre randomised controlled trial of shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones (TISU trial). Final project report to National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project Number 10/137/01).