Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
- Registration Number
- NCT00730418
- Lead Sponsor
- Samsung Medical Center
- Brief 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)
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description doxazosin 4mg Doxazosin doxazosin 4mg group doxazosin 8mg Doxazosin doxazosin 8mg group
- Primary Outcome Measures
Name Time Method Expression of alpha-1 adrenoceptor before treatment and 12mos and 24 mos after treatment
- Secondary Outcome Measures
Name Time Method International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events before treatment and 3mos, 12mos, and 24mos after treatment
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷SEoul, Korea, Republic of