Alfuzosin Versus Placebo in Acute Urinary Retention
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...
Brief Summary
Official Title: “Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Alfuzosin
Outcome Measures for this Clinical Trial
Primary Measures
- Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Secondary Measures
- 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.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Henning Andersen, MD Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00453908
Study ID Number: L_9397
ClinicalTrials.gov Identifier: NCT00453908
Health Authority: Denmark: Danish Medicines Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00453908
