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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
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.
University of Miami
Miami, Florida, United States
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
Time frame: Baseline, 3 months
Duration of hospitalization after the procedure
The duration of hospitalization associated with each procedure will be calculated in hours.
Time frame: up to 48 hours
Duration of urinary catheterization after the procedure
The duration of urinary catheterization associated with each procedure will be calculated in hours.
Time frame: up to 48 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
Time frame: Baseline, 12 months
Change in peak urine flow rate
The peak urine flow rate (Qmax) will be measured via uroflowmetry
Time frame: Baseline, 12 months
Change in post-void residual urinary volume (PVR)
PVR will be measured using an ultrasound bladder scanner
Time frame: Baseline, 12 months
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
Time frame: Baseline, 12 Months
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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
Time frame: Baseline, 12 Months
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.
Time frame: Baseline, 12 Months
Change in mean prostate volume
As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)
Time frame: Baseline, 12 months
Change in prostate specific antigen (PSA) levels
As measured by serum blood samples
Time frame: Baseline, 12 Months
Incidence of adverse events
As evaluated by treating physician
Time frame: Up to 12 Months
Incidence of procedure-related adverse events
As evaluated by treating physician
Time frame: Up to 12 Months
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
Time frame: Baseline, 12 Months