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
Study website
Contact information
Type
Scientific
Contact name
Dr Samuel McClinton
ORCID ID
Contact details
NHS Grampian
Department of Urology
Ward 44
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
+44 (0)1224 550517
smcclinton@nhs.net
Additional identifiers
EudraCT/CTIS number
2010-019469-26
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
HTA 08/71/01
Study information
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)
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
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
Patient information sheet
Patient information sheet may be downloaded from http://www.charttrials.abdn.ac.uk/suspend
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1200
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
NHS Grampian
Aberdeen
AB25 2ZB
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research and Innovation
Kings College
Regent Walk
Aberdeen
AB24 3FX
Scotland
United Kingdom
+44 (0)1224 272123
res-innov@abdn.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |