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Alfuzosin Versus Placebo in Acute Urinary Retention (ALF-RIK)

This study has been terminated.
(The study was early terminated due to slow and difficult recruitment)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00453908
First received: March 28, 2007
Last updated: August 17, 2007
Last verified: August 2007
History of Changes

March 28, 2007
August 17, 2007
May 2004
Not Provided
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Same as current
Complete list of historical versions of study NCT00453908 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Alfuzosin Versus Placebo in Acute Urinary Retention
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Retention
Drug: Alfuzosin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
Not Provided
Not Provided

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.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00453908
L_9397
No
Not Provided
Sanofi
Not Provided
Study Director: Henning Andersen, MD Sanofi
Sanofi
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP