Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    50
  • sponsor
    University of Virginia
Updated on 22 January 2021
digital rectal exam
transrectal ultrasound
hypertrophy
benign prostatic hypertrophy
lower urinary tract symptoms
artery embolization
uroflowmetry
benign prostatic hyperplasia
hyperplasia

Summary

The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Description

This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

Details
Condition Benign prostatic hypertrophy, Prostatism, Hyperplasia, Prostatic disorder, Male genital organ disease NOS, Male Urogenital Diseases, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), Lower Urinary Tract Symptoms, benign prostatic hyperplasia, benign prostatic hyperplasia (bph)
Treatment Embozene Microspheres
Clinical Study IdentifierNCT02592473
SponsorUniversity of Virginia
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients between ages 45-80 years
Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second)
All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging

Exclusion Criteria

Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
Cases of biopsy proven prostate cancer or urethral cancer
Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study
Patients who are classified as New York Heart Association Class III (Moderate), or higher
Patients with history of prior pelvic irradiation
Hypersensitivity reactions to contrast material not manageable with prophylaxis
Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50
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