Alfuzosin for Treating Acute Urinary Retention

NCT ID: NCT00336921

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

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).

Conditions

Acute Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Alfuzosin 10mg

Group Type: ACTIVE_COMPARATOR

Alfuzosin

Intervention Type: DRUG

Once daily

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily

Interventions

Alfuzosin

Once daily

Intervention Type: DRUG

Placebo

Once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Bruno Jolain

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis

Beijing, , China

Countries

China

Other Identifiers

L_9645

Identifier Type: -

Identifier Source: org_study_id