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21 March 2013
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| [ Print-friendly version ] |
| Therapeutic Interventions for Stones of the Ureter |
| ISRCTN | ISRCTN92289221 |
| DOI | 10.1186/ISRCTN92289221 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Therapeutic Interventions for Stones of the Ureter |
| Scientific title | A multicentre randomised controlled trial of extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones |
| Acronym | TISU |
| Serial number at source | HTA: 10/137/01 , 3/087/12 |
| Study hypothesis |
The hypothesis being tested is that outcome in patients receiving extracorporeal shockwave lithotripsy (ESWL) as their first treatment option is not inferior to outcome in patients receiving direct ureteroscopic retrieval.
More detailc can be found at http://www.hta.ac.uk/2938 |
| Lay summary |
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 smcclinton@nhs.net |
| Ethics approval | NRES Committees – North of Scotland, 15 February 2013, REC reference 13/NS/0002. |
| Study design | Multicentre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ureteric stone treatment |
| Participants - inclusion criteria |
1. Presence of stone confirmed by Computed Tomography Scan of the Kidneys, Ureters and Bladder (CTKUB)
2. Patients with a ureteric stone requiring removal 3. Adults ≥16 years of age 4. Single ureteric stone requiring treatment 5. Suitable for either ESWL or ureteroscopic treatment 6. Capable of giving written informed consent, which includes adherence with the requirements of the trial. |
| Participants - exclusion criteria |
1. Pregnancy
2. Stones not confirmed by CTKUB 3. Bilateral ureteric stone(s) 4. Patients with abnormal urinary tract anatomy (such as a horseshoe kidney or ileal conduit) 5. Patients unable to understand or complete trial documentation |
| Anticipated start date | 01/03/2013 |
| Anticipated end date | 28/02/2017 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1000 |
| Interventions |
Participants will be randomly allocated to either ESWL or ureteroscopy.
Extracorporeal shockwave lithotripsy (ESWL) involves generation of a shock-wave, external to the body, focused on the stone, causing it to fragment with the fragments subsequently passing spontaneously. A variety of systems (differing means of generating shock-waves, different focusing mechanisms) are available. It is routinely performed in an outpatient setting with pain relief or sedation as required. Recruitment will occur only in established centres with fixed-site lithotripters. This will allow some standardisation of protocols on times to treatment and ESWL delivery. Up to two sessions of ESWL will be considered as one intervention as per standard practice. Ureteroscopy is the use of small semi-rigid or flexible ureteroscopes, in conjunction with intracorporeal lithotripsy devices, such as the holmium laser, to directly visualise and fragment ureteric stones. Smaller stones, in the lower ureter, can often be removed intact using basketing devices. It is currently most often performed as a day-case procedure (but may require hospital admission depending on complexity) and usually requires general anaesthesia. Details of co-sponsor: NHS Grampain Aberdeen Royal Infirmary Foresterhill Aberdeen, AB25 2ZN United Kingdom |
| Primary outcome measure(s) |
The study has a primary clinical and a primary economic outcome reflecting the multidimensional nature of the possible effects the intervention may have.
Clinical: Clearance of ureteric stones operationally defined as “no further intervention required to facilitate stone clearance” up to 6 months from randomisation. Economic: Incremental cost per quality adjusted life years (QALYs) gained at 6 months from randomisation. QALYs are based on the responses to the EQ-5D. |
| Secondary outcome measure(s) |
Patient-reported (measured at pre and 1 week post intervention, 8 weeks and 6 months post randomisation):
1. Severity of pain as measured by the Numeric Rating scale (NRS) 2. Generic health profile as measured by the SF-12, (8 weeks and 6 months only) 3. Health status as measured by the EQ5D 4. Use of analgesia 5. Acceptability of received procedure (8 weeks and 6 months only) Clinical: Further interventions received, complications up to 6 months post randomisation Economic: NHS primary and secondary care use and costs up to 6 months, patient costs; incremental cost per surgical interventions averted. |
| Sources of funding | NIHR Health Technology Assessment - HTA (UK) (10/137/01) |
| Trial website | |
| Publications | |
| Contact name | Prof Sam McClinton |
| Address |
Department of Urology
Ward 44 Aberdeen Royal Infirmary Foresterhill |
| City/town | Aberdeen |
| Zip/Postcode | AB25 2ZB |
| Country | United Kingdom |
| smcclinton@nhs.net | |
| Sponsor | University of Aberdeen (UK) |
| Address |
Research and Innovation
University Office King’s College |
| City/town | Aberdeen |
| Zip/Postcode | AB24 3FX |
| Country | United Kingdom |
| Sponsor website: | http://www.abdn.ac.uk/ |
| Date applied | 07/02/2013 |
| Last edited | 21/02/2013 |
| Date ISRCTN assigned | 21/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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