Randomized Clinical Trial of Balloon-Occlusion versus Conventional Microcatheter Prostatic Artery Embolization for Benign Prostatic Hyperplasia

Abstract Purpose To compare balloon-occlusion prostatic artery embolization (bPAE) with conventional microcatheter PAE (cPAE). Materials and Methods In this single-center trial, between November 2017 and November 2018, 89 patients with symptomatic benign prostatic hyperplasia were randomly assigned to cPAE (n = 43) or bPAE (n = 46). All patients received embolization with 300–500 μm Embosphere microspheres and were evaluated before and 1 and 6 months after PAE. Primary outcome measure was change from baseline in International Prostate Symptom Score (IPSS). Student t test was used for between-group comparisons of change from baseline, and paired t test was used for within-group comparisons. Results At baseline, groups were identical (P > .05). Unilateral PAE was performed in 4 patients receiving cPAE and 3 patients receiving bPAE (9.30% and 6.52%, P = .708). Procedural and fluoroscopy times, dose area product, air kerma, embolic volume, and mean prostate-specific antigen (PSA) 24 hours after PAE did not differ between groups (P > .05). Coils were used in 6 patients receiving cPAE and 4 patients receiving bPAE (14.0% and 8.70%, P = .51). Assessments at 6 months after PAE showed mean IPSS reduction was 7.58 ± 6.88 after cPAE and 8.30 ± 8.12 after bPAE (P = .65); mean prostate volume reduction was 21.9 cm3 ± 51.6 (18.2%) after cPAE and 6.15 cm3 ± 14.6 (7.3%) after bPAE (P = .05); mean PSA reduction was 0.9 ng/mL ± 2.22 after cPAE and 0.22 ng/mL ± 1.65 after bPAE (P = .10). Penile skin lesions (n = 3) and rectal bleeding (n = 2) were documented only in patients receiving cPAE (11.9%, P = .01). No major adverse events occurred. Conclusions bPAE is as effective as cPAE in treating benign prostatic hyperplasia with a potential to reduce nontarget embolization.