Alfuzosin for Treating Acute Urinary Retention

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Acute Urinary Retention	Drug: Alfuzosin; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	156 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	February 2006
Actual Primary Completion Date :	April 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; Alfuzosin 10mg	Drug: Alfuzosin; Once daily
Placebo Comparator: 2; Placebo	Drug: Placebo; Once daily

Outcome Measures

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Primary Outcome Measures :

1. Percentage of patients with successful voiding after catheter removal [ Time Frame: Day 3 and 4 ]
2. Adverse events [ Time Frame: From the beginning to the end of the study ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
Sanofi-aventis
Beijing, China

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	Bruno Jolain	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00336921 History of Changes
Other Study ID Numbers:	L_9645
First Posted:	June 15, 2006
Last Update Posted:	September 15, 2009
Last Verified:	September 2009

Additional relevant MeSH terms:

Urinary Retention; 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