Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    30
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 20 June 2021
benign prostatic hypertrophy
alpha blocker
artery embolization
urinary symptoms
uroflowmetry
benign prostatic hyperplasia
hyperplasia

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 hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.

Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.

Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

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 prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.

Details
Condition Benign prostatic hypertrophy, Prostatic disorder, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), Enlarged Prostate, benign prostatic hyperplasia, benign prostatic hyperplasia (bph)
Treatment Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Clinical Study IdentifierNCT04398966
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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 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)
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