Urinary Retention
Conditions
Brief summary
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization. Furthermore is investigated the safety of the medical treatment and self-catheterization.
Interventions
DRUGAlfuzosin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men with acute urinary retention and catheterized * Benign hypertrophia of prostate * Patient is diagnosed in Emergency room or at a acute hospitalization
Exclusion criteria
* Known prostate cancer * Prior urinary retention within 30 days * Urinary retention occurring in relation to surgery * Blood in urine * Difficult or impossible catheterization * Fever \> 38 degree Celsius * Decreased kidney function * Permanent catheter \> 14 days * Treatment with alfa 1 blocker within 30 days * Meeting contraindications to treatment with Alfuzosin * Treatment with other drugs for urinary problems The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days until termination of self catheterization | — |
| Number of patients with urinary infection requiring treatment | — |
| Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14. | — |
Countries
Denmark
Outcome results
None listed