Condition category
Urological and Genital Diseases
Date applied
14/04/2010
Date assigned
18/11/2010
Last edited
06/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

http://www.charttrials.abdn.ac.uk/suspend

Contact information

Type

Scientific

Primary contact

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 number

2010-019469-26

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

Hospitals

Trial 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

Phase

Phase III

Drug names

Nifedipine, tamsulosin

Primary outcome measures

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 trial start date

01/09/2010

Overall trial end date

01/03/2014

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
+44 (0)1224 272123
res-innov@abdn.ac.uk

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24947817
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25998582
2015 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/26152519
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26244520

Publication citations

  1. Protocol

    McClinton S, Starr K, Thomas R, McLennan G, McPherson G, McDonald A, Lam T, N'Dow J, Kilonzo M, Pickard R, Anson K, Burr J, , Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial., Trials, 2014, 15, 238, doi: 10.1186/1745-6215-15-238.

  2. Results

    Pickard R, Starr K, MacLennan G, Lam T, Thomas R, Burr J, McPherson G, McDonald A, Anson K, N'Dow J, Burgess N, Clark T, Kilonzo M, Gillies K, Shearer K, Boachie C, Cameron S, Norrie J, McClinton S, Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial, Lancet, 2015 , doi: 10.1016/S0140-6736(15)60933-3.

  3. Results

    Starr K, McPherson G, Forrest M, Cotton SC, SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial, Trials, 2015, 16, 295, doi: 10.1186/s13063-015-0808-9.

  4. Results

    Pickard R, Starr K, MacLennan G, Kilonzo M, Lam T, Thomas R, Burr J, Norrie J, McPherson G, McDonald A, Shearer K, Gillies K, Anson K, Boachie C, N'Dow J, Burgess N, Clark T, Cameron S, McClinton S, Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-controlled, randomised controlled trial and cost-effectiveness analysis of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the SUSPEND trial)., Health Technol Assess, 2015 , 19, 63, 1-172.

Additional files

Editorial Notes