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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)

Primary Purpose

Urinary Retention, Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dutasteride
Sponsored by
Franklin D. Gaylis, MD Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Urinary retention secondary to benign prostatic hyperplasia

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2008
    Last Updated
    May 19, 2008
    Sponsor
    Franklin D. Gaylis, MD Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00680680
    Brief Title
    Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker
    Acronym
    AUR
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Franklin D. Gaylis, MD Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Retention, Benign Prostatic Hyperplasia
    Keywords
    Urinary retention secondary to benign prostatic hyperplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Dutasteride
    Intervention Description
    Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males betewen the ages of 50 and 90 years of age.Written informed consent. Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment. PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml. Exclusion Criteria: Urinary retention attributed to a neurogenic or myogenic bladder dysfunction. Use of psychotrophic medications. Use of antichollinergic medications. Prostate cancer. Allery to five alpha reductase inhibitors. Prior prostate surgery. Urethral stricture. Bladder calculi. Invasive bladder cancer. Inability to understand or agree with the requirements of the study. Any investigational drug received within 30 days prior of study entry.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franklin D Gaylis, MD
    Organizational Affiliation
    Director/Sponsor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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