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.
Information provided by:
Franklin D. Gaylis, MD Inc.
First received: May 16, 2008
Last updated: May 19, 2008
Last verified: May 2008
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.
Benign Prostatic Hyperplasia
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2008 (Final data collection date for primary outcome measure)
Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months
|Ages Eligible for Study:
||50 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680680
Franklin D. Gaylis, MD Inc.
||Franklin D Gaylis, MD
No publications provided
||Franklin D. Gaylis, M.D., MEDRESEARCH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 16, 2008
||May 19, 2008
||United States: Institutional Review Board
Keywords provided by Franklin D. Gaylis, MD Inc.:
Urinary retention secondary to benign prostatic hyperplasia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Genital Diseases, Male
5-alpha Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action