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
  Purpose

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 Intervention Phase
Urinary Retention
Drug: Alfuzosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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?

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome 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.

Estimated Enrollment: 160
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453908

Locations
Denmark
Sanofi-Aventis
Hoersholm, Denmark
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Henning Andersen, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00453908     History of Changes
Other Study ID Numbers: L_9397
Study First Received: March 28, 2007
Last Updated: August 17, 2007
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014