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Alfuzosin for Treating Acute Urinary Retention

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00336921
First received: June 14, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Acute Urinary Retention
 Drug: Alfuzosin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of patients with successful voiding after catheter removal [ Time Frame: Day 3 and 4 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: February 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Alfuzosin 10mg
 Drug: Alfuzosin
Once daily
Placebo Comparator: 2
Placebo
 Drug: Placebo
Once daily

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336921

Locations
China
Sanofi-aventis
Beijing, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Bruno Jolain Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00336921     History of Changes
Other Study ID Numbers: L_9645
Study First Received: June 14, 2006
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Urinary Retention
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013