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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)

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ClinicalTrials.gov Identifier: NCT00680680
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Urinary Retention Benign Prostatic Hyperplasia Drug: Dutasteride

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2004
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680680


Sponsors and Collaborators
Franklin D. Gaylis, MD Inc.
Investigators
Principal Investigator: Franklin D Gaylis, MD Director/Sponsor
More Information

Responsible Party: Franklin D. Gaylis, M.D., MEDRESEARCH
ClinicalTrials.gov Identifier: NCT00680680     History of Changes
Other Study ID Numbers: AUR
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urination Disorders
Urologic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs