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

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680680
• Other study ID #: AUR
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: May 19, 2008
• Start date: May 2004
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: Franklin D. Gaylis, MD Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Franklin D. Gaylis, MD Inc.