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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-02-01

Brief Summary

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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).

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Detailed Description

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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

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Holmium laser enucleation of the prostate

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

Group Type EXPERIMENTAL

Holmium laser enucleation of the prostate

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Artery embolization of the prostate

Intervention Type PROCEDURE

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

Interventions

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Holmium laser enucleation of the prostate

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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No