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

Samsung Medical Center

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Doxazosin

Study type

Interventional

Funder types

Other

Identifiers

NCT00730418

2006-08-118

Details and patient eligibility

About

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)

Full description

To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as

Real-time RT-PCR
Radioligand receptor binding
Western blot
Immunohistochemistry

Enrollment

25 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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