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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT04398966
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age ≥ 40
* Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound
* Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
* Capable of giving informed consent
* Life expectancy greater than 1 year
Exclusion Criteria:
* Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
* Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C \>8%
* Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
* A smoking history of 20 pack-year or greater obtained by patient report
* Prior myocardial infarction
* A stroke within the last 6 months
* Unstable angina
* Immunosuppression
* Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
* Complete urinary retention
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria
* Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
* Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained.
* Previous pelvic radiation or radical pelvic surgery
* Confirmed malignancy of the prostate or a history of prostate cancer
* Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT04398966
Study Brief:
Protocol Section:
NCT04398966