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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04236687
• Other study ID #: HBP01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2020
• Source: Germans Trias i Pujol Hospital
• Contact: Fernando Agreda, MD
• Phone: +34934893000
• Email: fagreda.germanstrias[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum urinary flow	Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s).	Baseline to 6 months after procedure
Secondary	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
Secondary	Prostate specific antigen (PSA)	Determination in plasma of the prostate specific antigen (PSA)	Baseline to 6 months after procedure
Secondary	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
Secondary	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
Secondary	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