Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
estimated completion

Description

Summary

Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Official Title

A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres

Details

This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months, 24 months and 36 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.

Keywords

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Prostatic Artery Embolization PAE BPH LUTS Embolization Embolic Embosphere Microsphere Prostatic Hyperplasia Hyperplasia Prostate artery embolization

Eligibility

You can join if…

Open to males ages 18 years and up

  • Patient has signed informed consent
  • Patient age is 18 years or older at time of informed consent
  • Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

You CAN'T join if...

  • Patient is unable or unwilling to provide follow-up information
  • Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
  • Any other reason the investigator deems cause for exclusion

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • University of California Los Angeles
    Los Angeles California 90095 United States
  • UC Irvine Health
    Orange California 92868 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merit Medical Systems, Inc.
ID
NCT03527589
Study Type
Observational [Patient Registry]
Last Updated