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

May 19, 2008 updated by: Franklin D. Gaylis, MD Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin D. Gaylis, MD Inc.

Investigators

  • Principal Investigator: Franklin D Gaylis, MD, Director/Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 19, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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