Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate (NCT05155891) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate
United States45 participantsStarted 2022-06-17
Plain-language 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.
Who can participate
Age range50 Years
SexMALE
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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.
. 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.