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Alfuzosin for Treating Acute Urinary Retention

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ClinicalTrials.gov Identifier: NCT00336921
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Sanofi

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

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Arms and Interventions
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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, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336921


Locations
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China
Sanofi-aventis
Beijing, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Bruno Jolain Sanofi
More Information
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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    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
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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