NCT00336921

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

June 14, 2006

Last Update Submit

September 14, 2009

Conditions

Acute Urinary Retention

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients with successful voiding after catheter removal

    Day 3 and 4

  • Adverse events

    From the beginning to the end of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Alfuzosin 10mg

Drug: Alfuzosin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AlfuzosinDRUG

Once daily

1
PlaceboDRUG

Once daily

2

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

Beijing, China

Location

MeSH Terms

Interventions

alfuzosin

Study Officials

  • Bruno Jolain

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 15, 2006

Study Start

February 1, 2006

Primary Completion

April 1, 2007

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

CN(1)