Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate

NCT05155891 | Active Not Recruiting FDA Device

• 1 other identifier: 20210029
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change in BPH symptoms as measured by the IPSS

  The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms

  Baseline, 3 months

Secondary Outcomes (13)

• Duration of hospitalization after the procedure

  up to 48 hours

• Duration of urinary catheterization after the procedure

  up to 48 hours

• Change in BPH symptoms as measured by IPSS

  Baseline, 12 months

• Change in peak urine flow rate

  Baseline, 12 months

• Change in post-void residual urinary volume (PVR)

  Baseline, 12 months

Study Arms (2)

Embosphere Microspheres group

EXPERIMENTAL

Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.

Device: Embosphere Microspheres

HoLEP Group

ACTIVE COMPARATOR

Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).

Procedure: HoLEP Procedure

Interventions

Embosphere Microspheres DEVICE

The SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter.

Embosphere Microspheres group

HoLEP Procedure PROCEDURE

The SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser.

HoLEP Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is age 50 or older.
• Patient has signed informed consent and agrees to attend all follow-up study visits.
• Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
• Patient has a baseline IPSS Score \> 13 at baseline.
• Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).
• Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.
• Patient must be a candidate for HoLEP or PAE.

You may not qualify if:

• Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
• Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
• Patients with indwelling urinary catheters or those performing self-catheterization.
• Biopsy proven prostate or bladder cancer.
• \- Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.
• Patients with neurogenic bladder disorder.
• Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition.
• Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).
• Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
• Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months.
• Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.
• Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm
• History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
• History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.
• History of hypersensitivity to gelatin products will be excluded from PAE arm.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hemendra Shah, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Urology

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: June 17, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)