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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00680680
Acronym
AUR
Enrollment
20
Registered
2008-05-20
Start date
2004-05-31
Completion date
2008-02-29
Last updated
2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Urinary Retention

Keywords

Urinary retention secondary to benign prostatic hyperplasia

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.

Interventions

DRUGDutasteride

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

Sponsors

Franklin D. Gaylis, MD Inc.
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026