THERAPEUTIC INTERVENTIONS FOR STONES OF THE URETER (TISU): A PRAGMATIC MULTICENTRE RANDOMISED CONTROLLED TIRAL OF EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY (ESWL) AT FIRST TREATMENT OPTION COMPARED WITH IMMEDIATE URETEROSCOPIC RETRIEVAL OF URETERIC STONES.

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 retrieval, for ureteric stones.

"1.8 million adults in the UK are affected by urinary stones. In some patients the stone travels and becomes lodged in the tube (ureter) between the kidney and bladder. This leads to excruciating pain in the abdomen and back (ureteric colic) that requires strong painkillers and often leads to emergency hospital admission. In most people the stones will pass in the urine within a few days but in 25% the stones need to be physically removed using the standard treatment options of either ureteroscopy or extracorporeal shock wave lithotripsy (ESWL). Ureteroscopy involves putting a telescope into the ureter and using a laser to break up the stone. ESWL breaks the stone into smaller pieces using a machine that passes shock-waves through the body. Both treatments are effective at getting rid of stones but have advantages and disadvantages. We are uncertain which of these standard treatments is best at getting rid of the stone in the most efficient way for the patients and the NHS.

Our study involves giving either ESWL or ureteroscopy to 1000 people with stones in the ureter that need removal, who agree to take part. They will be randomly allocated to have either ESWL or ureteroscopy to remove their stones. The study will include a network of UK hospitals over 48 months with each participant being studied for 6 months. We will measure whether any additional treatments are needed and what they are, the impact of the treatments on the health of the participants and pain experienced, any complications arising and which treatment represents best value for money. This information will be collected by asking the participants to complete 5 questionnaires over the 6 months and by staff at the study hospital completing case report forms.

We will start the study in at least three hospitals to assess whether we can recruit the necessary number of participants and deliver the intervention as expected.

Our research team is made up of specialists (urologists) who perform the procedures, a lay expert and experts in the design, performance and analysis of clinical trials. The study will be managed by a Clinical Trials Unit which is very experienced at running large multicentre randomised controlled trials within the NHS. We also have the support of the national organisation of doctors who treat ureteric stones. We will convene a Trial Steering Committee and Data Monitoring Committee which will meet annually to oversee the trial progress.

The study will last 48 months. This includes 5 months to set up the study; 29 months to set up the centres, recruit participants and deliver the interventions, a further 8 months to complete the follow up on all participants and 6 months to analyse, write up and close down the study."