Alfuzosin Versus Placebo in Acute Urinary Retention

Urinary Retention Clinical Trial

— ALF-RIK  

Official title:

Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453908
• Other study ID #: L_9397
• Status: Terminated
• Phase: Phase 3
• First received: March 28, 2007
• Last updated: August 17, 2007
• Start date: May 2004

Study information

• Verified date: August 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Drug:
• Alfuzosin

Locations

Country	Name	City	State
Denmark	Sanofi-Aventis	Hoersholm

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Secondary	Number of days until termination of self catheterization
Secondary	Number of patients with urinary infection requiring treatment
Secondary	Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.