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

NCT00680680 | Completed

• 1 other identifier: AUR
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Retention; Benign Prostatic Hyperplasia

Keywords

Urinary retention secondary to benign prostatic hyperplasia

Interventions

Dutasteride DRUG

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franklin D. Gaylis, MD Inc.: lead

MeSH Terms

Conditions

Urinary Retention; Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Franklin D Gaylis, MD

  Director/Sponsor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: May 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05