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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290030

Enrollment

800

Registered

2006-02-10

Start date

2001-05-31

Completion date

2004-10-31

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Urinary Retention, Prostatic Hyperplasia

Keywords

acute urinary retention, International Prostate Symptom Score (IPSS)

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Interventions

DRUGAlfuzosin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the safety of alfuzosin in this population, and health care consumption	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026