Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
The purpose of this observational study is to evaluate the prostatic arterial embolization
 (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the
 treatment of symptomatic benign prostatic hyperplasia (BPH).
EmboProstate is an observational study that collects data of patients with benign prostatic
 hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The
 study evaluates the efficacy and safety of the microspheres for prostatic arterial
 embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be
 enrolled in this study. If eligible patients are recruited, they will undergo the prostate
 artery embolization procedure in our radiology department. Once the catheter is placed in the
 prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected
 through the catheter into these small arteries which nourish the prostate. The injected
 embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused
 by BPH. Within one week after PAE as well as after one, three and six months post-procedure
 an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.
Inclusion Criteria:

 -  male

 -  adults > 40 years old

 -  severe symptomatic BPH with IPSS > 18 and/or QoL > 3 or maximum urinary flow rate
 (Qmax) ≤ 15 ml/sec or transurethral catheter for retention

 -  no improvement after or intolerance of medical treatment for at least six months

 -  prostatic volume > 30 cm³

 Exclusion Criteria:

 -  female

 -  less than 40 years old

 -  eGFR < 45 ml/min * m²

 -  suspicion of prostatic malignancy

 -  prostatic malignancy

 -  acute prostatitis or cystitis

 -  hydronephrosis

 -  bladder stone or bladder diverticulum

 -  urethral stenosis

 -  major surgery within 4 weeks prior to the screening visit

 -  active clinically serious infection

 -  progressive arteriosclerosis

 -  contraindications against angiography