Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia

Germans Trias i Pujol Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Benign Prostatic Hyperplasia

Interventions

Holmium laser enucleation of the prostateDEVICE

Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra

Artery embolization of the prostatePROCEDURE

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

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Outcomes

Primary Outcomes

Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)

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)