Alfuzosin for Treating Acute Urinary Retention

Acute Urinary Retention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336921
• Other study ID #: L_9645
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2006
• Last updated: September 14, 2009
• Start date: February 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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 a-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 a1-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 ß 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Urinary Retention
• Urinary Retention

Intervention

Drug:
• Alfuzosin
Once daily
• Placebo
Once daily

Locations

Country	Name	City	State
China	Sanofi-aventis	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with successful voiding after catheter removal		Day 3 and 4	No
Primary	Adverse events		From the beginning to the end of the study	Yes