Urinary stone disease is very common with an estimated prevalence among the general population of 2–3% (1.8 million people in the UK) and is a major burden on the NHS. Urinary tract stones, and ureteric stones, in particular, are associated with severe pain as they pass through the urinary tract 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. 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
TISU is a multicentre randomised controlled trial, funded by the NIHR HTA Programme, of ESWL as first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones. The clinical and cost-effectiveness of ESWL, as the first treatment option compared with ureteroscopic treatment will be determined with respect to the primary outcomes of:
clinical stone clearance, defined as no further intervention required to facilitate stone passage
incremental cost per quality adjusted life years (QALYs) and
disease or treatment-related harms up to 6 months after randomisation.
TISU recruited 613 participants.
Adults (≥ 16 years old), presenting with a unilateral ureteric stone within any segment of the ureter, confirmed by computed tomography scan of the kidneys, ureters, and bladder (CTKUB), are recruited into the trial and participants were randomised to one of the treatment options.
The TISU trial is led by Professor Sam McClinton based at the University of Aberdeen.