Alfuzosin Versus Placebo in Acute Urinary Retention

Phase 3TerminatedNCT00453908

Sanofi160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Urinary Retention

Interventions

AlfuzosinDRUG

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Hoersholm, Denmark

Outcomes

Primary Outcomes

Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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