Status:
TERMINATED
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Terumo Medical Corporation
Conditions:
BPH
Enlarged Prostate (BPH)
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplas...
Detailed Description
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04398966
Start Date
September 23 2020
End Date
May 8 2023
Last Update
May 7 2024
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599