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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin

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.

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

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Henning Andersen, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on November 20, 2008

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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