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
  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:


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 April 16, 2014