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

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Official Title
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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)

Conditions
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Prostatic Hyperplasia, Acute Urinary Retention

Intervention / Treatment
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* Drug: Alfuzosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of alfuzosin in this population, and health care consumption |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute urinary retention, International Prostate Symptom Score (IPSS)