Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
The purpose of this study is to evaluate improvement of symptoms from benign prostatic
 hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate
 artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional
 Holmium laser enucleation of the prostate (HoLEP).
This is a prospective randomized controlled study that collects data of patients with benign
 prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with
 Holmium laser enucleation of the prostate (HoLEP). For PAE a 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
 microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used
 to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include
 clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be
 recorded. The patients fill in the questionnaires for urologic disease. Urodynamic
 examination will record functional outcome.
Inclusion Criteria:

 -  Patients evaluated in the urology department and candidates to surgical treatment

 -  Age > 45 years

 -  IPSS ≥ 10

 -  Maximum urinary flow < 12 milliliters (mL)/second (s)

 -  Post-void residual urinary volume < 300mL

 -  Prostatic volume between 20mL and 250mL assessed by ultrasound

 -  Signed informed consent

 Exclusion Criteria:

 -  PSA > 10 (if not negative prostate biopsy)

 -  Life expectancy below 1 year

 -  Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2

 -  Known severe reactions to iodine-based contrast or gadolinium-based contrast

 -  CT examination reveals no access to the prostate arteries.