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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is comparing two treatments for enlarged prostates in terms of symptoms and side effects.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in BPH symptoms as measured by the IPSS
Secondary outcome measures
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

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).

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,650 Total Patients Enrolled
1 Trials studying Enlarged Prostate
50 Patients Enrolled for Enlarged Prostate
Shivank Bhataia, MDPrincipal InvestigatorUniversity of Miami

Media Library

Embosphere Microspheres (Embolization Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05155891 — N/A
Enlarged Prostate Research Study Groups: Embosphere Microspheres group, HoLEP Group
Enlarged Prostate Clinical Trial 2023: Embosphere Microspheres Highlights & Side Effects. Trial Name: NCT05155891 — N/A
Embosphere Microspheres (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155891 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria currently satisfied for participation in this trial?

"Clinicaltrials.gov states that this trial is not currently enrolling patients, even though the it was posted back in June 17th of 2022 and updated on September 9th. However, there are 137 other studies seeking participants at present."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate
Shivank Bhatia 2022. "Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155891.
All > Benign Prostatic Hyperplasia > Bph
~49 spots leftby Jan 2027
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