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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02313233
Eligibility Criteria:
Inclusion Criteria:
* Males aged \>=40 years old
* Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
* Prostate volume \>= 20 cm3
* Has complained of voiding symptoms related to BPH
* Has an IPSS \>= 13 or an UFR measure of Qmax \<= 15 ml/sec together with a voided volume \>= 150 ml.
* Serum PSA \< 6.5 ng/ml
* Has been treated with medication for BPH
* Informed consent form signed.
Exclusion Criteria:
* Sensitivity to study product
* Had received prostatic surgery for BPH during the past 24 weeks
* Hard nodule found by DRE
* Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
* Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
* Participation of any clinical investigation during the last 30 days.
* Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT02313233
Study Brief:
Protocol Section:
NCT02313233