2:02 PM Abstract No. 154 - Early findings from a prospective US trial: prostatic artery embolization (pae) in the treatment of benign prostatic hyperplasia (BPH)

Abstract

Purpose To present early findings from a prospective US trial: Prostatic Artery Embolization (PAE) in the Treatment of Benign Prostatic Hyperplasia (BPH). The purpose of this trial is to study the safety and efficacy of PAE over 2 years, using spherical embolic material, in the treatment of lower urinary tract symptoms (LUTS). Materials and Methods A prospective trial to perform PAE in 30 patients with moderate or severe grade LUTS has been approved by our Institutional Review Board. Inclusion criteria are: age ≥ 50, AUA score ≥ 8, maximum urinary flow rate 1.6, bladder or prostate carcinoma, or neurogenic bladder. AUA score, Prostate Volume, Peak Urine Flow and Post-void Residual Volume are assessed at baseline and at 6 months. Patients are evaluated at 1,3,12, and 24 months with AUA and sexual function scales (International Index of Erectile Function). Primary endpoints are clinical improvement as measured by AUA score at 12 and 24 months. Seven patients (mean age 70, range 63-80) who signed informed written consent, underwent angiographic. Mean baseline AUA score was 23.8 (range 22-28). Embolization was performed using spherical embolic material (Embozene, Celonova Biosciences San Antonio, TX). Mean prostate volume at baseline was 54.2 cc (range 29-92 cc). Results Embolization was technically successful in 6/7 patients (86%) and bilateral in 6/6 (100%) patients. One technically unsuccessful embolization was secondary to atherosclerotic occlusion of the prostatic arteries. Six patients were discharged on the same day as the procedure and one patient was observed overnight. No patients required bladder catheterization for the procedure or post-procedure. No patients experienced procedural pain, however all patients did experience transient increase in urinary frequency for 24 hours. Clinical improvement at 1 month was noted in all (100%) patients with a mean AUA score of 13 (range 7-17). No minor or major complications were encountered. Conclusion Early results of PAE are encouraging with symptomatic improvement and lack of complication. Continued enrollment with long term follow-up is ongoing.