Embosphere® PROstate Post Market Study
Embosphere® PROstate Post Market Study
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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