Clinical trial NCT04236687: Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)
timeFrame: Baseline to 6 months after procedure
Secondary outcomes:
measure: Maximum urinary flow
timeFrame: Baseline to 6 months after procedure
measure: Post-void residual urinary volume
timeFrame: Baseline to 6 months after procedure
measure: Prostate specific antigen (PSA)
timeFrame: Baseline to 6 months after procedure
measure: Procedure related adverse events
timeFrame: Baseline to 6 months after procedure
measure: Procedure related effects on sexual function
timeFrame: Baseline to 6 months after procedure
measure: Procedure related effects on urinary continence
timeFrame: Baseline to 6 months after procedure
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Fernando Agreda, MD
role: PRINCIPAL_INVESTIGATOR
References: