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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embosphere Microspheres
HoLEP Procedure
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is age 50 or older.
  2. Patient has signed informed consent and agrees to attend all follow-up study visits.
  3. Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
  4. Patient has a baseline IPSS Score > 13 at baseline.
  5. 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).
  6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.
  7. Patient must be a candidate for HoLEP or PAE.

Exclusion Criteria:

  1. Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
  2. Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
  3. Patients with indwelling urinary catheters or those performing self-catheterization.
  4. 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.

  5. Patients with neurogenic bladder disorder.
  6. 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.
  7. Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).
  8. 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.
  9. 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.
  10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.
  11. Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm
  12. 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.
  13. History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.
  14. History of hypersensitivity to gelatin products will be excluded from PAE arm.
  15. Subject has a life expectancy of less than 2 yrs.
  16. Post void residual more than 500 ml at baseline.
  17. Participation in any other BPH trials during the time of study.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Embosphere Microspheres group

HoLEP Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of hospitalization after the procedure
The duration of hospitalization associated with each procedure will be calculated in hours.
Duration of urinary catheterization after the procedure
The duration of urinary catheterization associated with each procedure will be calculated in hours.
Change in BPH symptoms as measured by IPSS
International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
Change in peak urine flow rate
The peak urine flow rate (Qmax) will be measured via uroflowmetry
Change in post-void residual urinary volume (PVR)
PVR will be measured using an ultrasound bladder scanner
Change in erectile function as measured by the IIEF
The International Index of Erectile Function (IIEF) has a total score ranging from 0-25 with higher score indicating better erectile function
Change in retrograde ejaculation as measured by the Ejaculatory questionnaire
The Ejaculatory Questionnaire has a total score ranging from 0-20 with the higher score indicating better outcomes
Change in incontinence as measured by the ICIQ - UI SF
The International Consultation on Incontinence Questionnaire (ICIQ) -Urinary Incontinence (UI) Short Form (SF) is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Change in mean prostate volume
As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)
Change in prostate specific antigen (PSA) levels
As measured by serum blood samples
Incidence of adverse events
As evaluated by treating physician
Incidence of procedure-related adverse events
As evaluated by treating physician
Change in medication use related to BPH-LUTS
Change in BPH lower urinary tract symptoms (LUTS) medication use (including alpha blockers, 5-alpha reductase inhibitors and phosphodiesterase type 5 (PDE5) inhibitors) will be reported

Full Information

First Posted
November 30, 2021
Last Updated
August 23, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05155891
Brief Title
Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate
Official Title
Prospective, Non-Randomized, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Prostate Glands Larger Than 80 Grams
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embosphere Microspheres group
Arm Type
Experimental
Arm Description
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.
Arm Title
HoLEP Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Embosphere Microspheres
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
HoLEP Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BPH symptoms as measured by the IPSS
Description
The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Duration of hospitalization after the procedure
Description
The duration of hospitalization associated with each procedure will be calculated in hours.
Time Frame
up to 48 hours
Title
Duration of urinary catheterization after the procedure
Description
The duration of urinary catheterization associated with each procedure will be calculated in hours.
Time Frame
up to 48 hours
Title
Change in BPH symptoms as measured by IPSS
Description
International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
Time Frame
Baseline, 12 months
Title
Change in peak urine flow rate
Description
The peak urine flow rate (Qmax) will be measured via uroflowmetry
Time Frame
Baseline, 12 months
Title
Change in post-void residual urinary volume (PVR)
Description
PVR will be measured using an ultrasound bladder scanner
Time Frame
Baseline, 12 months
Title
Change in erectile function as measured by the IIEF
Description
The International Index of Erectile Function (IIEF) has a total score ranging from 0-25 with higher score indicating better erectile function
Time Frame
Baseline, 12 Months
Title
Change in retrograde ejaculation as measured by the Ejaculatory questionnaire
Description
The Ejaculatory Questionnaire has a total score ranging from 0-20 with the higher score indicating better outcomes
Time Frame
Baseline, 12 Months
Title
Change in incontinence as measured by the ICIQ - UI SF
Description
The International Consultation on Incontinence Questionnaire (ICIQ) -Urinary Incontinence (UI) Short Form (SF) is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Time Frame
Baseline, 12 Months
Title
Change in mean prostate volume
Description
As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)
Time Frame
Baseline, 12 months
Title
Change in prostate specific antigen (PSA) levels
Description
As measured by serum blood samples
Time Frame
Baseline, 12 Months
Title
Incidence of adverse events
Description
As evaluated by treating physician
Time Frame
Up to 12 Months
Title
Incidence of procedure-related adverse events
Description
As evaluated by treating physician
Time Frame
Up to 12 Months
Title
Change in medication use related to BPH-LUTS
Description
Change in BPH lower urinary tract symptoms (LUTS) medication use (including alpha blockers, 5-alpha reductase inhibitors and phosphodiesterase type 5 (PDE5) inhibitors) will be reported
Time Frame
Baseline, 12 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Subject has a life expectancy of less than 2 yrs. Post void residual more than 500 ml at baseline. Participation in any other BPH trials during the time of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivank Bhataia, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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