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

• ClinicalTrials.gov Identifier: NCT00290030
• Recruitment Status: Completed
• First Posted: February 10, 2006
• Last Update Posted: March 12, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.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 (Clinical Trial)
• 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 2001
• Actual Primary Completion Date: October 2004
• Actual Study Completion Date: October 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: ICD CSD; Sanofi

More Information

Additional Information:

Related Info 

• Responsible Party: ICD Study Director, sanofi-aventis
• ClinicalTrials.gov Identifier: NCT00290030
• Other Study ID Numbers: EFC4428; SL 770499-10
• First Posted: February 10, 2006
• Last Update Posted: March 12, 2009
• Last Verified: March 2009

Keywords provided by Sanofi:

acute urinary retention; International Prostate Symptom Score (IPSS)

Additional relevant MeSH terms:

Prostatic Hyperplasia; Urinary Retention; Hyperplasia; Pathologic Processes; Prostatic Diseases; Urination Disorders; Urologic Diseases; Alfuzosin; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents