What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate (BPH) include medications like alpha blockers and 5-alpha-reductase inhibitors, minimally invasive procedures such as Prostate Artery Embolization (PAE) and Holmium Laser Enucleation of the Prostate (HoLEP), and surgical options like transurethral resection of the prostate (TURP). Side effects of these treatments can vary. Medications may cause dizziness, fatigue, and sexual dysfunction. PAE, which blocks blood supply to reduce prostate size, can lead to urinary tract infections, blood in urine, and temporary pain or discomfort. HoLEP and TURP may result in bleeding, infection, and retrograde ejaculation. Overall, while these treatments are effective, they come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for an enlarged prostate (BPH) primarily include medications such as alpha-blockers (e.g., tamsulosin, alfuzosin) and 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), which help to relax prostate muscles and shrink the prostate, respectively. Minimally invasive surgical options like transurethral resection of the prostate (TURP) and laser therapies (e.g., Holmium Laser Enucleation of the Prostate, HoLEP) are also approved. While Prostate Artery Embolization (PAE) is being studied for its efficacy in reducing prostate size by blocking blood supply, it is not yet a widely FDA-approved treatment for BPH.

What other types of research exist?

Promising, novel alternatives to Prostate Artery Embolization for treating an enlarged prostate include the Urolift system and bioabsorbable self-reinforced poly L-lactic acid urethral stents combined with finasteride. The Urolift system is a minimally invasive surgical option that has been reviewed positively for its effectiveness in managing benign prostatic hyperplasia (BPH). Additionally, the combination of bioabsorbable stents with finasteride has shown potential in pilot studies for treating acute urinary retention due to benign prostatic enlargement.

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Embolization Agent

Embolization vs HoLEP Procedure for Enlarged Prostate

N/A

Waitlist Available

Led By Shivank Bhataia, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be a candidate for HoLEP or PAE.

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).

Must not have

Patients with neurogenic bladder disorder

Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from PAE may include discomfort at the catheter insertion site or allergic reactions to materials used. HoLEP could cause irritation during urination, blood in urine temporarily after surgery or rare risks like loss of ejaculation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for prostate surgery or artery embolization.

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

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

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I am eligible for HoLEP or PAE surgery.

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I am 50 years old or older.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurogenic bladder disorder.

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I currently have an untreated infection.

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I have been diagnosed with or treated for chronic prostatitis or pelvic pain.

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My prostate or bladder cancer was confirmed by a biopsy.

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I cannot have procedures that block blood vessels due to a health condition.

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I haven't been hospitalized for heart failure, arrhythmia, severe diabetes, respiratory disease, or immunosuppression in the last 6 months.

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I do not have any urethral or bladder conditions affecting my urine flow, other than BPH.

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I have not had prostate surgery or treatments like TURP or Green Light laser in the last year.

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I have a bleeding disorder that cannot be corrected with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in BPH symptoms as measured by the IPSS

Secondary study objectives

Change in BPH symptoms as measured by IPSS

Change in erectile function as measured by the IIEF

Change in incontinence as measured by the ICIQ - UI SF

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Embosphere Microspheres groupExperimental Treatment1 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 GroupActive Control1 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).

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for an enlarged prostate (Benign Prostatic Hyperplasia, BPH) include alpha-adrenergic blockers, 5-alpha-reductase inhibitors, and minimally invasive surgical options like Prostate Artery Embolization (PAE). Alpha-adrenergic blockers, such as tamsulosin, work by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. 5-alpha-reductase inhibitors, like finasteride, reduce the size of the prostate by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to prostate growth. PAE, a newer treatment, involves blocking the blood supply to the prostate, causing it to shrink. These treatments are crucial for managing symptoms, improving quality of life, and reducing the risk of complications associated with BPH.