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Alfuzosin for Treating Acute Urinary Retention

Primary Purpose

Acute Urinary Retention

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alfuzosin
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Urinary Retention

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Alfuzosin 10mg

Placebo

Outcomes

Primary Outcome Measures

Percentage of patients with successful voiding after catheter removal
Adverse events

Secondary Outcome Measures

Full Information

First Posted
June 14, 2006
Last Updated
September 14, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00336921
Brief Title
Alfuzosin for Treating Acute Urinary Retention
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Alfuzosin 10mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Percentage of patients with successful voiding after catheter removal
Time Frame
Day 3 and 4
Title
Adverse events
Time Frame
From the beginning to the end of the study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Jolain
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis
City
Beijing
Country
China

12. IPD Sharing Statement

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Alfuzosin for Treating Acute Urinary Retention

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