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.
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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.
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: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Eligibility
Minimum age: 50 Years.
Maximum age: 90 Years.
Gender(s): Male.
Criteria:
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
Ending date: February 2008
Last updated: May 19, 2008
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