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:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00759135
Eligibility Criteria:
Inclusion Criteria:
1. Documented history of BPH for at least 1 year
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec
Exclusion Criteria:
1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Surgery or MIST in the previous 12 months for treatment of BPH
5. Post-void residual urine volume \> 350 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT00759135
Study Brief:
Protocol Section:
NCT00759135