Alfuzosin Versus Placebo in Acute Urinary Retention
Phase 3
Terminated
- Conditions
- Urinary Retention
- Registration Number
- NCT00453908
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 160
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇩🇰Hoersholm, Denmark