Therapeutic Interventions for Stones of the Ureter
Research type
Research Study
Full title
Therapeutic Interventions for Stones of the Ureter (TISU): a multicentre randomised controlled trial of extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones.
IRAS ID
119835
Contact name
Samuel McClinton
Contact email
Sponsor organisation
University of Aberdeen
Research summary
Research Summary\n\nUrinary stones are a major health burden resulting in nearly 90,000 finished consultant episodes and 109,000 bed-days in NHS England. Between a fifth and a third of cases require an active intervention (stone removal). The two standard options are extracorporeal shockwave lithotropsy (ESWL) or ureteroscopic stone removal. A Cochrane review highlighted uncertainty regarding which is most clinically effective and the true cost to the NHS and society. This multi-centre non-inferiority RCT (with internal feasibility) will compare ESWL as a first treatment option, with direct progression to ureteroscopic treatment, with respect to i) stone clearance (no further intervention required to facilitate stone passage, ii) incremental cost per quality adjustment life years (QALYs), iii) patient reported outcomes, and iv) complications up to 6 months. The trial results will guide clinical practice and appropriate provision of NHS services.\n\nLay summary of study results\nAbout one in twenty people suffer from kidney stones that pass down the urine drainage tube (ureter) into the urinary bladder and cause episodes of severe pain (ureteric colic). People with ureteric colic attend hospital for pain relief and diagnosis. Most stones smaller than 10mm eventually reach the bladder and are passed during urination. However some get stuck and have to be removed using telescopic surgery (called ’Ureteroscopy’) or shockwave therapy (called ’Shockwave Lithotripsy’).\n\nUreteroscopy uses a thin telescope, through which instruments can be used. The telescope is passed through the bladder and into the ureter, to break up and/or remove the stone. This is usually performed as a day case, under general anaesthetic. For Shockwave Lithotripsy the patient lies flat on a couch and the machine underneath them generates shockwaves. These shockwaves pass through the skin to the ureter and break the stones into smaller pieces which can be passed naturally in the urine. Shockwave Lithotripsy involves an x-ray or ultrasound to find the stone. It can be done without a general anaesthetic as an outpatient. Telescopic surgery is known to be more successful at removing stones after just one treatment but requires more time in hospital and has a higher risk of complications than Shockwave Lithotripsy. Shockwave Lithotripsy may require more than one session of treatment.\n\nThe TISU study was designed to find out if treatment for ureteric colic should start with telescopic surgery or shockwave therapy. Over 600 NHS patients took part and they were split into two groups, each patient had an equal chance of their treatment starting with either telescopic surgery or Shockwave Lithotripsy, decided by a computer program (random allocation). We counted how many patients in each group had further procedures to remove their stone. We found that telescopic surgery was 12% more effective overall with an associated slightly better quality of life (10 more healthy days over the six month period) but more expensive in an NHS setting. There was no significant additional clinical benefit of telescopic surgery. We concluded that the most cost-effective treatment pathway is Shockwave Lithotripsy first with only those that fail going on to have telescopic surgery
REC name
North of Scotland Research Ethics Committee 2
REC reference
13/NS/0002
Date of REC Opinion
11 Jan 2013
REC opinion
Favourable Opinion