Alfuzosin for Treating Acute Urinary Retention

Study Overview
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Brief Summary
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The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).

Official Title
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A Double-blind, Randomized,Placebo Controlled Study of Alfuzosin 10mg od in the Return to Successful Voiding in Patients With a First Episode of Acute Urinary Retention Due to Benign Prostatic Hyperplasia

Conditions
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Acute Urinary Retention

Intervention / Treatment
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* Drug: Alfuzosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First episode of painful AUR related to BPH requiring catheterization Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization Exclusion Criteria: Participated in another investigational study within 3 months before recruitment Suspect bladder neuro-dysfunction unrelated to etiology; Single Bladder neck disease; Acute/chronic prostatitis; Diagnosed prostate carcinoma; Suspected prostate carcinoma diagnosed by ultrasound wave; Surgical history of prostate and urethra; Diagnosed/suspected abnormality in urethra structure; Bladder stone; Blood urine retention caused by any reason; Residual volume less than 500 ml Residual volume more than 1500 ml AUR not due to BPH Parkinson's disease Insulin dependent diabetes Known/suspected multiple sclerosis; Stroke/MI within 6 months prior to enrolment; AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³; Unstable/severe heart failure; History of postural hypertension/hypotension; Known hypersensitivity to α-receptor blocker; Suspected/diagnosed expansible nerval disease; Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently; Treatment with α1-receptor blocker within 1 month prior to enrolment; Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease); Treatment with Disopyramide The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Alfuzosin 10mg | Drug: Alfuzosin<br>* Once daily<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with successful voiding after catheter removal |  | Day 3 and 4 | 
| Adverse events |  | From the beginning to the end of the study |