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

Germans Trias i Pujol Hospital

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Holmium laser enucleation of the prostate; Procedure: Artery embolization of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT04236687

HBP01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Holmium laser enucleation of the prostate

Experimental group

Description:

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

Treatment:

Device: Holmium laser enucleation of the prostate

Artery embolization of the prostate

Active Comparator group

Description:

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.

Treatment:

Procedure: Artery embolization of the prostate