Embolization vs HoLEP Procedure for Enlarged Prostate

Recruiting in Palo Alto (17 mi)

Overseen by Shivank Bhataia, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is evaluating two methods for addressing prostate issues to determine which one better improves symptoms in patients.

Eligibility Criteria

Men over 50 with enlarged prostates (80-250 grams) and moderate to severe symptoms not improved by medication can join this study. They must have an IPSS Score >13, indicating significant urinary issues, and be eligible for PAE or HoLEP procedures. Those who've had certain prostate treatments in the last year, have serious bleeding disorders, allergies to specific medical substances, untreated infections, cancer diagnoses, or other major health conditions cannot participate.

Inclusion Criteria

I am eligible for prostate surgery or artery embolization.

Patient has signed informed consent and agrees to attend all follow-up study visits

My prostate is between 80 and 250 grams as measured by MRI or ultrasound.

Exclusion Criteria

History of hypersensitivity to gelatin products will be excluded from PAE arm

History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm

I have a neurogenic bladder disorder.

Participant Groups

The trial is comparing two different procedures for treating an enlarged prostate: Prostate Artery Embolization (PAE), which blocks blood flow to reduce size; and Holmium Laser Enucleation of Prostate (HoLEP), a laser treatment that removes excess tissue. The goal is to see which method better improves symptoms.

Group I: Embosphere Microspheres group Experimental Treatment 1 Intervention

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.

Group II: HoLEP Group Active Control 1 Intervention

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).

Embosphere Microspheres is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Embosphere Microspheres for:

• Uterine fibroid embolization

🇪🇺 Approved in European Union as Embosphere Microspheres for:

• Uterine fibroid embolization

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Who Is Running the Clinical Trial?

University of Miami Lead Sponsor

References