Extrait

Background and study aims Ureteric stones (kidney stone) are very common and painful; 2-3% of the general population (1.8 million in the UK) have suffered from this condition. Ureteric stones can pass in their own time and some patients only require initial treatment with pain killers and, if appropriate, anti-sickness medication and drugs which relax the muscle fibres of the ureter. In some cases the treatments described above do not work or patients are not suitable for such care and further routine intervention (stone removal) is required. This study is investigating two methods used to remove stones: • Extracorporeal Shockwave Lithotripsy (ESWL), which is a shockwave treatment applied from the outside of the body, and • Ureteroscopic stone treatment, a telescopic procedure to remove the stone. Who can participate? Adults male and female, aged 16 years or older who have a single ureteric stone in the ureter can take part. What does the study involve? Participants who agree to take part will be randomly allocated to either ESWL or ureteroscopy. All participants are followed up for a period of six months. Participants complete questionnaires about their general health, pain and use of pain killers at the time they join the study, directly before their treatment and again one week after the procedure. At approximately eight weeks and six months after joining the trial participants complete further questionnaires. In addition, following their ureteric stone treatment, participants will return to an outpatient clinic at their recruiting hospital to check how they are getting on. If their symptoms are still not adequately controlled they may receive further treatment as necessary. What are the possible benefits and risks of participating? There may be no direct benefit to patients who take part, but they will be helping with this research enabling doctors to assess which treatment is best and safest. Where is the study run from? The study is co-ordinated by the Centre for Healthcare Randomised Trials (CHaRT) and is co-sponsored by the University of Aberdeen and NHS Grampian. When is the study starting and how long is it expected to run for? The study will begin in March 2013 and run till February 2017. Who is funding the study? NHS National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Health Technology Assessment programme (NETSCC HTA). Who is the main contact? Prof S McClinton [email protected]

Critère d'inclusion

• Ureteric stone treatment

Liens

• isrctn
• ictrp