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Alfuzosin for Treating Acute Urinary Retention

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00336921
Collaborator
(none)
156
Enrollment
1
Location
2
Arms

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2006
Actual Primary Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Alfuzosin 10mg

Drug: Alfuzosin
Once daily
Placebo Comparator: 2

Placebo

Drug: Placebo
Once daily

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with successful voiding after catheter removal [Day 3 and 4]

  2. Adverse events [From the beginning to the end of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanofi-aventis Beijing China

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Bruno Jolain, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00336921
Other Study ID Numbers:
  • L_9645
First Posted:
Jun 15, 2006
Last Update Posted:
Sep 15, 2009
Last Verified:
Sep 1, 2009
Additional relevant MeSH terms:
Urinary Retention
Alfuzosin

Study Results

No Results Posted as of Sep 15, 2009