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Completed

NCT Number: NCT00290030

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

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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Key information

Conditions

Prostatic Hyperplasia Acute Urinary Retention Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfuzosin

Drug

Primary outcomes

  1. Successful voiding in initial period (using an active voiding trial)

  2. No relapse during the 6 month treatment period

  3. No need / indication for surgery during the initial or 6 month treatment periods

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Feb 10, 2006
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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