Alfuzosin for Treating Acute Urinary Retention

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

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.