Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker (AUR)

This study has been completed.

Sponsor:

Information provided by:

Franklin D. Gaylis, MD Inc.

ClinicalTrials.gov Identifier:

NCT00680680

First received: May 16, 2008

Last updated: May 19, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

May 19, 2008

Start Date ^ICMJE

May 2004

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00680680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker

Official Title ^ICMJE

Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH

Brief Summary

To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Urinary Retention
Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: Dutasteride

Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males betewen the ages of 50 and 90 years of age.Written informed consent.
Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment.
PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml.

Exclusion Criteria:

Urinary retention attributed to a neurogenic or myogenic bladder dysfunction.
Use of psychotrophic medications.
Use of antichollinergic medications.
Prostate cancer.
Allery to five alpha reductase inhibitors.
Prior prostate surgery.
Urethral stricture.
Bladder calculi.
Invasive bladder cancer.
Inability to understand or agree with the requirements of the study.
Any investigational drug received within 30 days prior of study entry.

Gender

Male

Ages

50 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00680680

Other Study ID Numbers ^ICMJE

AUR

Has Data Monitoring Committee

Responsible Party

Franklin D. Gaylis, M.D., MEDRESEARCH

Study Sponsor ^ICMJE

Franklin D. Gaylis, MD Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Franklin D Gaylis, MD

Director/Sponsor

Information Provided By

Franklin D. Gaylis, MD Inc.

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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