ALF-RIK: Alfuzosin Versus Placebo in Acute Urinary Retention

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00453908
• Collaborator: (none)
• Enrollment: 160
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Drug: Alfuzosin	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
• Study Start Date: May 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Number of days until termination of self catheterization []

2. Number of patients with urinary infection requiring treatment []

3. Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Hoersholm		Denmark

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Henning Andersen, MD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00453908
• Other Study ID Numbers: L_9397
• First Posted: Mar 29, 2007
• Last Update Posted: Aug 20, 2007
• Last Verified: Aug 1, 2007

• Additional relevant MeSH terms: Urinary Retention; Alfuzosin

Study Results

No Results Posted as of Aug 20, 2007