Alfuzosin Versus Placebo in Acute Urinary Retention

NCT00453908 | Terminated Phase 3

• 1 other identifier: L_9397
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.

Secondary Outcomes (3)

• 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.

Interventions

Alfuzosin DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with acute urinary retention and catheterized
• Benign hypertrophia of prostate
• Patient is diagnosed in Emergency room or at a acute hospitalization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Hoersholm, Denmark

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Henning Andersen, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: May 1, 2004
• Last Updated: August 20, 2007

Record last verified: 2007-08

Locations

DK (1)