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

Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic 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.

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.

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

Change in prostatic symptoms using the International Prostate Symptom Score (IPSS). IPSS score goes from 0 to 35. Higher values mean worse outcome (prostate symptons)

Evaluation of Procedure related adverse events assessed by Clavien-Dindo modified score. Clavien Dindo modified score: the score goes from 1 to 5. Higher values mean worse outcome (surgical complications)

Changes in sexual function assessed by International Index of Erectile Function (IIEF) score. IIEF: the score goes from 6 to 75. Lower values mean worse outcome (overall male sexual function).

Changes in urinary continence assessed by the International Consultation on Continence Questionnaire Short Form (ICIQ-SF). ICIQ-SF: score goes from 0 to 21. Higher values mean worse outcome (urinary continence)

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.