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

May 16, 2008
May 19, 2008
May 2004
February 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00680680 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Urinary Retention
  • Benign Prostatic Hyperplasia
Drug: Dutasteride
Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Male
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00680680
AUR
No
Franklin D. Gaylis, M.D., MEDRESEARCH
Franklin D. Gaylis, MD Inc.
Not Provided
Principal Investigator: Franklin D Gaylis, MD Director/Sponsor
Franklin D. Gaylis, MD Inc.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP