Overview

Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
Male
Summary
In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Adrenergic Agents
Doxazosin
Criteria
Inclusion Criteria:

- 50 yrs or greater

- International prostatic symptom score >= 8

- Maximal flow rate < 15mL/sec

- baseline PSA 2.5-10 ng/mL

- Pathologically proven BPH

- No medication history for BPH

- Able to give fully informed consent

Exclusion Criteria:

- Previous use of alpha-blocker, 5-alpha reductase inhibitor

- Previous surgery for BPH

- Urologic cancer history

- Urethral stricture

- baseline PSA > 10ng/mL

- BP < 90/70 mmHg

- Orthotopic hypotension with syncope

- Serum Cr > 2.0 mg/dl, alanine aminotransferase > 1.5 times of normal limit

- Bacterial prostatitis within 1 year

- Urinary tract infection(UTI) more than 2 times within 1 year

- Active UTI or prostate biopsy within 1 month

- Unable to void

- Ped use because of incontinence

- Hypersensitivity to alpha-blocker that include quinazoline

- Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months

- Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal
injury etc.)

- Psychiatric problem

- Alcohol abuse or other drug abuse history

- Severe comorbidities unable to perform long-term trial

- seems not to be appropriate to this study because of any other reasons