Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT00730418
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00730418
Study Brief:
Protocol Section:
NCT00730418