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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 (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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

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:
    Drug: Dutasteride
    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:

  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.
  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

No publications provided

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

Keywords provided by Franklin D. Gaylis, MD Inc.:
Urinary retention secondary to benign prostatic hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Urinary Retention
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urination Disorders
Urologic Diseases
Adrenergic alpha-Antagonists
 Dutasteride
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013