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OpenTrials
Completed

NCT Number: NCT00680680

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

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.

Completed

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Key information

Conditions

Urinary Retention Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urination Disorders Urogenital Diseases Urologic Diseases

Age range

50 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

dutasteride

Drug

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

Sponsors and collaborators

Lead sponsor

Franklin D. Gaylis, MD Inc.

Other

Registry information

Official study title

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

Acronym: AUR

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 20, 2008
Registry last updated
May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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