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

Phase 3

Completed

• Conditions: Prostatic Hyperplasia; Acute Urinary Retention

• Registration Number: NCT00290030
• Lead Sponsor: Sanofi

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.

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.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

• Study Start: 2001-05
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess the safety of alfuzosin in this population, and health care consumption