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

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: Holmium laser enucleation of the prostate
* Procedure: Artery embolization of the prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holmium laser enucleation of the prostate<br>Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra | Device: Holmium laser enucleation of the prostate<br>* Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra<br>|
| Active Comparator: Artery embolization of the prostate<br>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. | Procedure: Artery embolization of the prostate<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to 6 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum urinary flow | Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s). | Baseline to 6 months after procedure | 
| Post-void residual urinary volume | Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL) | Baseline to 6 months after procedure | 
| Prostate specific antigen (PSA) | Determination in plasma of the prostate specific antigen (PSA) | Baseline to 6 months after procedure | 
| Procedure related adverse events | 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) | Baseline to 6 months after procedure | 
| Procedure related effects on sexual function | 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). | Baseline to 6 months after procedure | 
| Procedure related effects on urinary continence | 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) | Baseline to 6 months after procedure |