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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00290030

Collaborator

(none)

800

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia Acute Urinary Retention	Drug: Alfuzosin	Phase 3

Detailed Description

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Successful voiding in initial period (using an active voiding trial) []
No relapse during the 6 month treatment period []
No need / indication for surgery during the initial or 6 month treatment periods []

Secondary Outcome Measures

To assess the safety of alfuzosin in this population, and health care consumption []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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