Alfuzosin for Treating Acute Urinary Retention
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ClinicalTrials.gov Identifier: NCT00336921 |
Recruitment Status :
Completed
First Posted : June 15, 2006
Last Update Posted : September 15, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Urinary Retention | Drug: Alfuzosin Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 156 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Alfuzosin 10mg
|
Drug: Alfuzosin
Once daily |
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Once daily |
- Percentage of patients with successful voiding after catheter removal [ Time Frame: Day 3 and 4 ]
- Adverse events [ Time Frame: From the beginning to the end of the study ]

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336921
China | |
Sanofi-aventis | |
Beijing, China |
Study Director: | Bruno Jolain | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00336921 |
Other Study ID Numbers: |
L_9645 |
First Posted: | June 15, 2006 Key Record Dates |
Last Update Posted: | September 15, 2009 |
Last Verified: | September 2009 |
Urinary Retention Urination Disorders Urologic Diseases Alfuzosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |