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

Not Applicable

Active, not recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: Embosphere Microspheres; Procedure: HoLEP Procedure

• Registration Number: NCT05155891
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2022-06-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embosphere Microspheres group	Embosphere Microspheres	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.
HoLEP Group	HoLEP Procedure	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).

Primary Outcome Measures

Name	Time	Method
Change in BPH symptoms as measured by the IPSS	Baseline, 3 months	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

Name	Time	Method
Change in post-void residual urinary volume (PVR)	Baseline, 12 months	PVR will be measured using an ultrasound bladder scanner
Change in BPH symptoms as measured by IPSS	Baseline, 12 months	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	Baseline, 12 months	The peak urine flow rate (Qmax) will be measured via uroflowmetry
Change in erectile function as measured by the IIEF	Baseline, 12 Months	The International Index of Erectile Function (IIEF) has a total score ranging from 0-25 with higher score indicating better erectile function
Change in incontinence as measured by the ICIQ - UI SF	Baseline, 12 Months	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.
Incidence of adverse events	Up to 12 Months	As evaluated by treating physician
Incidence of procedure-related adverse events	Up to 12 Months	As evaluated by treating physician
Duration of hospitalization after the procedure	up to 48 hours	The duration of hospitalization associated with each procedure will be calculated in hours.
Change in retrograde ejaculation as measured by the Ejaculatory questionnaire	Baseline, 12 Months	The Ejaculatory Questionnaire has a total score ranging from 0-20 with the higher score indicating better outcomes
Change in prostate specific antigen (PSA) levels	Baseline, 12 Months	As measured by serum blood samples
Duration of urinary catheterization after the procedure	up to 48 hours	The duration of urinary catheterization associated with each procedure will be calculated in hours.
Change in mean prostate volume	Baseline, 12 months	As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)
Change in medication use related to BPH-LUTS	Baseline, 12 Months	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States