Back to resultsAlfuzosin Versus Placebo in Acute Urinary Retention (ALF-RIK)
Primary Purpose
Urinary Retention
Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453908
Brief Title
Alfuzosin Versus Placebo in Acute Urinary Retention
Acronym
ALF-RIK
Official Title
Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
The study was early terminated due to slow and difficult recruitment
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Primary Outcome Measure Information:
Title
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Secondary Outcome Measure Information:
Title
Number of days until termination of self catheterization
Title
Number of patients with urinary infection requiring treatment
Title
Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Andersen, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Hoersholm
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Alfuzosin Versus Placebo in Acute Urinary Retention
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