NCT04236687

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Holmium laser enucleation of the prostate	Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
PROCEDURE	Artery embolization of 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

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-02-01
• Completion: 2022-02-01
• First posted: 2020-01-22
• Last updated: 2020-01-22

Locations

1 site across 1 country: Spain