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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Urinary Retention

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453908

L_9397

Details and patient eligibility

About

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.

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind