A randomised controlled trial comparing spontaneous ureteric stone passage rates with tamsulosin versus placebo in the management of acute renal colic

ISRCTN	ISRCTN24675122
DOI	https://doi.org/10.1186/ISRCTN24675122
Secondary identifying numbers	N0234135766

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 28/03/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kim Davenport
Scientific

Urology Department
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Email	DrKimDav@aol.com

Study information

Study design	Randomised, double-blind, placebo-controlled, multi-centre trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Can tamsulosin, an alpha-1-adrenergic antagonist, be used in uncomplicated renal colic to improve spontaneous ureteric calculus passage rates.
Ethics approval(s)	1. Approval for the lead centre: Central and South Bristol Research Ethics Committee. Date of approval: 24/09/2004 (ref: 04/Q2006/88). All other centres obtained approval before recruitment of participants. 2. Medicines and Healthcare products Regulatory Agency (MHRA). Approval expected in May 2008.
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Acute renal colic
Intervention	As of 28/03/2013 the trial status was changed to 'stopped' as the trial was closed in January 2011 due to recruitment issues. Please note that, as of 11/04/2008, the anticipated start and end dates of this trial were updated from 01/06/2005 and 01/04/2007 to 01/05/2008 and 31/05/2010. This study is proposed to be a prospective, randomised double blind placebo controlled clinical trial. The patients will be randomly allocated to receive tamsulosin or placebo for a maximum of 6 weeks during conservative treatment of renal colic. Patients will be regularly monitored for side effects, stone passage and analgesic use during this time period.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tamsulosin
Primary outcome measure	Primary outcome measures amended as of 11/04/2008: 1. Spontaneous stone passage within 6 weeks 2. Early intervention due to complications Primary outcome measures provided at time of registration: 1. The percentage of calculi passed spontaneously within 6 weeks 2. The mean time to spontaneous passage 3. The mean use of analgesia in the form of diclofenac (recommended first line analgesic)
Secondary outcome measures	Added as of 11/04/2008: The following will be assessed at the end of the trial, i.e. time of stone passage or 6 weeks if stone not passed: 1. Percentage of calculi passed spontaneously within six weeks 2. Mean time to spontaneous passage 3. Mean use of analgesia in the form of diclofenac
Overall study start date	01/05/2008
Completion date	31/05/2010
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	206
Key inclusion criteria	The total sample size required to produce statistically significant results is 206 patients (103 to receive placebo). All patients with renal colic with a visible calculus on X-ray which has been confirmed to be present within the ureter on intravenous urogram (IVU) will be asked to participate.
Key exclusion criteria	Patients will be excluded if pregnant, symptoms present for >14 days, evidence of infection or if they are already receiving treatment with tamsulosin or other calcium channel blocker.
Date of first enrolment	01/05/2008
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Urology Department

Bristol
BS10 5NB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Bristol NHS Trust (UK)

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