Clinical trial NCT05155891: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 45
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in BPH symptoms as measured by the IPSS
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Duration of hospitalization after the procedure
timeFrame: up to 48 hours
measure: Duration of urinary catheterization after the procedure
timeFrame: up to 48 hours
measure: Change in BPH symptoms as measured by IPSS
timeFrame: Baseline, 12 months
measure: Change in peak urine flow rate
timeFrame: Baseline, 12 months
measure: Change in post-void residual urinary volume (PVR)
timeFrame: Baseline, 12 months
measure: Change in erectile function as measured by the IIEF
timeFrame: Baseline, 12 Months
measure: Change in retrograde ejaculation as measured by the Ejaculatory questionnaire
timeFrame: Baseline, 12 Months
measure: Change in incontinence as measured by the ICIQ - UI SF
timeFrame: Baseline, 12 Months
measure: Change in mean prostate volume
timeFrame: Baseline, 12 months
measure: Change in prostate specific antigen (PSA) levels
timeFrame: Baseline, 12 Months
measure: Incidence of adverse events
timeFrame: Up to 12 Months
measure: Incidence of procedure-related adverse events
timeFrame: Up to 12 Months
measure: Change in medication use related to BPH-LUTS
timeFrame: Baseline, 12 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hemendra Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: