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

Information source: Franklin D. Gaylis, MD Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Retention; Benign Prostatic Hyperplasia

Intervention: Dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: Franklin D. Gaylis, MD Inc.

Official(s) and/or principal investigator(s):
Franklin D Gaylis, MD, Principal Investigator, Affiliation: Director/Sponsor


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.

Clinical Details

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

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


Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Male.


Inclusion Criteria: 1. Males betewen the ages of 50 and 90 years of age. Written informed consent. 2. Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment. 3. PSA level equal to or greater than 1. 5ng/ml and equal to or less than 15 ng/ml. Exclusion Criteria: 1. Urinary retention attributed to a neurogenic or myogenic bladder dysfunction. 2. Use of psychotrophic medications. 3. Use of antichollinergic medications. 4. Prostate cancer. 5. Allery to five alpha reductase inhibitors. 6. Prior prostate surgery. 7. Urethral stricture. 8. Bladder calculi. 9. Invasive bladder cancer. 10. Inability to understand or agree with the requirements of the study. 11. Any investigational drug received within 30 days prior of study entry.

Locations and Contacts

Additional Information

Starting date: May 2004
Last updated: May 19, 2008

Page last updated: August 20, 2015

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