Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr T Shah

ORCID ID

Contact details

Urology Department
St. Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050072990

Study information

Scientific title

A randomised, placebo controlled study of alfuzosin in patients undergoing trial without catheter following admission with acute urinary retention

Acronym

Study hypothesis

To evaluate the role of an alpha-1 adrenoceptor antagonist in the treatment of acute urinary retention. To test the hypothesis that oral alfuzosin will increase the proportion of men in acute urinary retention who void after trial without catheter (AVR).

Ethics approval

Not provided at time of registration

Study design

Randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Signs and Symptoms: Acute urinary retention

Intervention

Randomised, placebo-controlled study at two centres. The aim of the study is to evaluate the effectiveness of alpha-adrergic blocker alfuzosin SR 5 mg given to patients in acute urinary retention prior to trial without catheter (TWOC). If successful it would reduce the number of operative treatments for patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH).

Intervention type

Drug

Phase

Not Applicable

Drug names

Alfuzosin

Primary outcome measures

Successful outcome will be measured in terms of spontaneous voiding

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

05/02/2050

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with acute urinary retention who meet inclusion criteria

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Added 18/03/2010: 81

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

05/02/2050

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. Luke's Hospital
Bradford
BD5 0NA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

Lorex Synthelabo Ltd (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

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12361896

Publication citations

  1. Results

    Shah T, Palit V, Biyani S, Elmasry Y, Puri R, Flannigan GM, Randomised, placebo controlled, double blind study of alfuzosin SR in patients undergoing trial without catheter following acute urinary retention., Eur. Urol., 2002, 42, 4, 329-32; discussion 332.

Additional files

Editorial Notes