Status:
COMPLETED
Alfuzosin for Treating Acute Urinary Retention
Lead Sponsor:
Sanofi
Conditions:
Acute Urinary Retention
Eligibility:
MALE
50-80 years
Phase:
PHASE2
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 retent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00336921
Start Date
February 1 2006
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi-aventis
Beijing, China