Therapeutic interventions for stones of the ureter
| ISRCTN | ISRCTN92289221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92289221 |
| Secondary identifying numbers | HTA 10/137/01, 3/087/12 |
- Submission date
- 07/02/2013
- Registration date
- 21/02/2013
- Last edited
- 21/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English 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?
Patients aged 16 or older who have a single ureteric stone in the ureter
What does the study involve?
Participants are randomly allocated to be treated with 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 painkillers at the time they join the study, directly before their treatment and again one week after the procedure. At about 8 weeks and 6 months after joining the trial participants complete further questionnaires. In addition, following their ureteric stone treatment, participants 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 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 (UK)
When is the study starting and how long is it expected to run for?
March 2013 to 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) (UK)
Who is the main contact?
Prof. S McClinton
smcclinton@nhs.net
Contact information
Scientific
Department of Urology
Ward 44
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| smcclinton@nhs.net |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | TISU |
| 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. |
| Ethics approval(s) | NRES Committees - North of Scotland, 15/02/2013, ref: 13/NS/0002 |
| Condition | Ureteric stone treatment |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | Patient-reported, measured at pre and 1 week post intervention, 8 weeks and 6 months post randomisation: 1. Severity of pain measured by the Numeric Rating scale (NRS) 2. Generic health profile measured by the SF-12 (8 weeks and 6 months only) 3. Health status 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. |
| Overall study start date | 01/03/2013 |
| Overall study end date | 28/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 613 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/03/2013 |
| Recruitment end date | 28/02/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZB
United Kingdom
Sponsor information
University/education
Research and Innovation
University Office
Kings College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Hospital/treatment centre
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
Scotland
United Kingdom
| Website | http://www.nhsgrampian.org/nhsgrampian/gra_display_home_2015.jsp?p_applic=CCC&p_service=Content.show&pContentID=9298& |
|---|---|
|
"ROR" |
https://ror.org/00ma0mg56 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | evaluation of recruitment processes | 11/08/2017 | Yes | No | |
| Protocol article | protocol | 22/05/2018 | Yes | No | |
| Results article | sub study results | 10/02/2021 | 22/02/2021 | Yes | No |
| Results article | 31/03/2021 | 21/02/2022 | Yes | No | |
| Results article | 01/03/2022 | 21/03/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/03/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
21/02/2022: Publication reference added.
22/02/2021: Publication reference added.
24/05/2018: Publication reference added.
15/08/2017: Publication reference added.
