Spontaneous Urinary Stone Passage ENabled by Drugs
| ISRCTN | ISRCTN69423238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69423238 |
| EudraCT/CTIS number | 2010-019469-26 |
| Secondary identifying numbers | HTA 08/71/01 |
- Submission date
- 14/04/2010
- Registration date
- 18/11/2010
- Last edited
- 06/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
A kidney stone is a piece of solid material that forms in the kidney when minerals in the urine become very concentrated. If stones grow to sufficient size they can cause blockage of the ureter (the tube that carries urine from the kidney to the bladder) and can be very painful. They are a common cause of emergency hospital admission due to severe pain and requirement for pain relief, time off work and often repeated hospital admissions for treatment. Drugs that cause relaxation of the ureter can enhance the spontaneous passage of ureteric stones. The drugs Tamsulosin and Nifedipine can improve the passage of ureteric stones and the process is termed medical expulsive therapy (MET). This avoids the need for further treatment. The aim of this study is to determine the clinical effectiveness and cost-effectiveness of the use of Tamsulosin and Nifedipine in the management of ureteric stones.
Who can participate?
Patients aged 18-65 with a confirmed ureteric stone.
What does the study involve?
Participants will be randomly allocated to be treated with either Nifedipine, Tamsulosin or placebo (dummy) tablets. Participants will take one capsule orally per day for a maximum of 28 days and will be followed up by postal questionnaires sent from the trial office at 4 and 12 weeks after random allocation. In addition patients may be reviewed in clinic at 4 weeks after random allocation.
What are the possible benefits and risks of participating?
The potential benefits to participants are that the pain and discomfort caused by their ureteric stone will be relieved sooner and they may avoid additional treatment. There may be no personal benefit from taking part in the study as there is no guarantee that the MET therapy will be successful, but participants will be offered other treatments if symptoms get worse or do not improve. By taking part in the study participants will be directly helping in the treatment of future patients diagnosed with ureteric stones. The results of the study will help plan effective services offered by the NHS. Some patients may report side effects to the study medications but these are usually mild and disappear after a short while. The medications used are not new drugs and have been used in routine use for many years for other health problems.
Where is the study run from?
The study will be conducted in secondary care units across the UK. Co-ordination of the study will occur at the Centre for Healthcare Randomised Trials (CHaRT) in the Health Services Research Unit, University of Aberdeen.
When is the study starting and how long is it expected to run for?
From January 2011 to October 2013.
Who is funding the study?
The National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.
Who is the main contact?
Professor Sam McClinton
smclinton@nhs.net
SUSPEND trial office
suspend@abdn.ac.uk
Contact information
Scientific
NHS Grampian
Department of Urology
Ward 44
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| Phone | +44 (0)1224 550517 |
|---|---|
| smcclinton@nhs.net |
Study information
| Study design | Multicentre double-blind placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information sheet may be downloaded from http://www.charttrials.abdn.ac.uk/suspend |
| Scientific title | Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre placebo controlled randomised trial of a calcium channel blocker (nifedipine) and an α blocker (tamsulosin) |
| Study acronym | SUSPEND |
| Study hypothesis | What is the clinical and cost-effectiveness of the use of an α blocker (tamsulosin) and a calcium channel blocker (nifedipine) in the management of symptomatic urinary stones. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/087101 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/53064/PRO-08-71-01.pdf On 20/03/2013 the following changes were made to the trial record: 1. The overall trial end date was changed from 30/11/2012 to 31/10/2013. 2. The target number of participants was changed from 2000 to 1200. On 09/04/2013 the overall trial end date was changed from 31/10/2013 to 01/03/2014. |
| Ethics approval(s) | The Fife and Forth Valley Research Ethics Committee, 04/08/2010, ref: 10/S0501/31 |
| Condition | Symptomatic Ureteric Stones |
| Intervention | Participants will be randomised to one of the following treatment groups. 1. The calcium channel blocker nifedipine, 30 mg once per day 2. The α-blocker tamsulosin, 0.4 mg once per day 3. Placebo once per day Participants will take one capsule orally per day for a maximum of 28 days and will be followed-up by postal questionnaires sent from the trial office at four and 12 weeks after randomisation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Nifedipine, tamsulosin |
| Primary outcome measure | 1. Spontaneous passage of ureteric stones at four weeks (defined as no further intervention required to facilitate stone passage) 2. Incremental cost per quality adjusted life years (QALYs) gained at 12 weeks. QALYs are based on the responses to the EQ-5D. |
| Secondary outcome measures | 1. Patient-reported outcomes, at baseline, 4 and 12 weeks: 1.1. Severity of pain as measured by Verbal descriptor scale (VDS) and Numeric Rating scale (NRS) 1.2. Generic health profile as measured by the SF 36 and use of analgesia 2. Clinical outcomes: 2.1. Time to passage of stone 2.2. Further interventions received at 12 weeks 3. Safety: Patient reported discontinuation of trial medications 4. Cost effectiveness: 4.1. NHS primary and secondary care use and costs up to three months, incremental cost per surgical interventions averted 4.2. Modelled incremental cost per QALY beyond the 12 week trial follow-up |
| Overall study start date | 01/09/2010 |
| Overall study end date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1200 |
| Participant inclusion criteria | 1. Patients presenting acutely with ureteric colic 2. Adults ≥18 ≤ 65 years of age 3. Presence of stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB), or by intravenous urogram (IVU) with subsequent CTKUB confirmation within 12 hours 4. Stone within any segment of the ureter 5. Unilateral ureteric stone 6. Largest stone dimension ≤10 mm 7. Female subjects must be post menopausal (defined as 12 months with no menses without an alternative medical cause), permanently sterilised or willing to use two methods of contraception listed in the protocol prior to the start of dosing until at least 28 days after receiving the last dose of trial medication 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form |
| Participant exclusion criteria | 1. Women who have a known or suspected pregnancy 2. Women who are breastfeeding 3. Asymptomatic incidentally found ureteric stone 4. Stone not confirmed by CTKUB 5. Stone with any one dimension >10 mm 6. Kidney stone without the presence of ureteric stone 7. Multiple (i.e. ≥ 2) stones within ureter 8. Bilateral ureteric stones 9. Stone in a ureter draining a solitary kidney (either anatomically or functionally) 10. Patients with abnormal renal tract anatomy (such as a duplex system, horseshoe kidney or ileal conduit) 11. Presence of urinary sepsis 12. Chronic renal failure (estinated Glomerular Filtration Rate [eGFR] < 30ml/min) 13. Patients currently taking an α blocker 14. Patients currently taking a calcium channel blocker 15. Patients currently taking PDE5 inhibitors 16. Contraindication or allergy to tamsulosin or nifedipine 17. Patients who are unable to understand or complete trial documentation |
| Recruitment start date | 01/01/2011 |
| Recruitment end date | 31/10/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZB
United Kingdom
Sponsor information
University/education
Research and Innovation
Kings College
Regent Walk
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Phone | +44 (0)1224 272123 |
|---|---|
| res-innov@abdn.ac.uk | |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/06/2014 | Yes | No | |
| Results article | substudy results | 08/07/2015 | Yes | No | |
| Results article | results | 25/07/2015 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
