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

Not Applicable

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: Holmium laser enucleation of the prostate; Procedure: Artery embolization of the prostate

• Registration Number: NCT04236687
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-21
• Last Update Submitted: 2020-01-21
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22
• Study Start: 2020-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holmium laser enucleation of the prostate	Holmium laser enucleation of the prostate	Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
Artery embolization of the prostate	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. The injected microspheres will slow the blood flow to the prostate.

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)	Baseline to 6 months after procedure	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain