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

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.

Sponsored by:	Franklin D. Gaylis, MD Inc.
Information provided by:	Franklin D. Gaylis, MD Inc.
ClinicalTrials.gov Identifier:	NCT00680680

Purpose

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.

Condition	Intervention
Urinary Retention Benign Prostatic Hyperplasia	Drug: Dutasteride

Drug Information available for: Dutasteride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH

Further study details as provided by Franklin D. Gaylis, MD Inc.:

Estimated Enrollment:	20
Study Start Date:	May 2004
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680680

Sponsors and Collaborators

Franklin D. Gaylis, MD Inc.

Investigators

Principal Investigator:

Franklin D Gaylis, MD

Director/Sponsor

More Information

Responsible Party:	MEDRESEARCH ( Franklin D. Gaylis, M.D. )
Study ID Numbers:	AUR
Study First Received:	May 16, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00680680
Health Authority:	United States: Institutional Review Board

Keywords provided by Franklin D. Gaylis, MD Inc.:

Urinary retention secondary to benign prostatic hyperplasia

Study placed in the following topic categories:

Dutasteride
Hyperplasia
Prostatic Diseases
Urologic Diseases
Prostatic Hyperplasia

Urination Disorders
Neoplasm Metastasis
Genital Diseases, Male
Urinary Retention

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009