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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 uteroscopic treatment, for ureteric stones.

Urinary stone disease is very common with an estimated prevalence among the general population of 2–3% with males forming stones three times as often as females.  Urinary stones often recur and the lifetime recurrence rate is approximately 50%.  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.

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.

The research question that we will address is whether in adults with ureteric stones judged to require active intervention, extracorporeal shockwave lithotripsy (ESWL) is more effective and cost-effective compared to ureteroscopic treatment as the initial management option.  Recruitment will occur only in established centres with fixed-site lithotripters.

This study is funded by the NHS National Institute for Health Research Health Technology Assessment Programme (ref - 10/137/01)

General Data Protection Regulation (GDPR) - Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 10 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information

The Health Services Research Unit is funded by the Chief Scientists Office of the Scottish Government Health and Social Care Directorates