ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-10-31

Brief Summary

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To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH.

To assess the safety of alfuzosin in this population and health care consumption.

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Detailed Description

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Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.

Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Conditions

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Prostatic Hyperplasia Acute Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Alfuzosin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male aged over 50 years
* Having given his written consent
* Presenting with a first episode of painful acute urinary retention related to BPH
* With a catheterized urine volume between mL and mL at the time of retention

Exclusion Criteria

* Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
* Iatrogenic causes of urinary retention

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No