Alfuzosin Versus Placebo in Acute Urinary Retention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Alfuzosin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Henning Andersen, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Hoersholm, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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L_9397

Identifier Type: -

Identifier Source: org_study_id