A randomised, placebo controlled study of alfuzosin in patients undergoing trial without catheter following admission with acute urinary retention
| ISRCTN | ISRCTN36163730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36163730 |
| Protocol serial number | N0050072990 |
| Sponsor | Department of Health (UK) |
| Funder | Lorex Synthelabo Ltd (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr T Shah
Scientific
Scientific
Urology Department
St. Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, placebo controlled study of alfuzosin in patients undergoing trial without catheter following admission with acute urinary retention |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Alfuzosin |
| Primary outcome measure(s) |
Successful outcome will be measured in terms of spontaneous voiding |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 81 |
| Key inclusion criteria | Patients with acute urinary retention who meet inclusion criteria |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St. Luke's Hospital
Bradford
BD5 0NA
United Kingdom
BD5 0NA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/02/2020: Internal review.
01/08/2017: internal correction on recruitment end date.
