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

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.