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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin
  • Once daily
• Drug: Placebo
  • Once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Alfuzosin 10mg
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Percentage of patients with successful voiding after catheter removal
  • Time Frame: Day 3 and 4
    Safety Issue?: No
• Adverse events
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Bruno Jolain Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00336921

Study ID Number: L_9645

ClinicalTrials.gov Identifier: NCT00336921

Health Authority: China: State Food and Drug Administration