Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study

Abstract

ObjectiveTo evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). MethodsA prospective, single-center, open-label FDA-approved study was conducted to evaluate the safety and efficacy of PAE for LUTS secondary to BPH. We enrolled men ≥ 45, prostate volume > 40 g, International prostate symptom score (IPSS) > 13, peak flow rate (Qmax) ≤ 12 mL/s, and voided volume ≥ 125 mL. Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL], International index of erectile function, and male sexual health questionnaire for ejaculatory dysfunction) and clinical measures (postvoid residual volume and Qmax at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results45 patients (mean volume: 99 cc, range: 30-214 g) were treated over the course of the 3-year study. At 1 month, there were improvements in IPSS (23.6 ± 6.1 to 12.0 ± 5.9, P < .0001), QoL (4.8 ± 0.9 to 2.6 ± 1.6, P < .0001), Qmax (5.8 ± 1.0 to 12.4 ± 6.8,P < .0001). At 3 months, there were improvements in IPSS (10.2 ± 6.0, P < .0001), QoL (2.4 ± 1.6, P < .0001) and Qmax (15.3 ± 12.3, P < .0001). At 6 months, there were improvements in IPSS (11.0 ± 7.6, P < .0001) and QoL (2.3 ± 1.7, P < .0001). At 1 year, there were improvements in IPSS (12.4 ± 8.4,P < .0001) and QoL (2.6 ± 1.6, P < .0001). There were reductions in postvoid volume residues: baseline 157 ± 45, 1 month 123 ± 47, P = .057, 3 months 127 ± 114, P = .34, 6 months 112±116, P = .002 and 1 year 109±116 P = .025. Median decreases in TV and CG were 18% (CI: 13-27) (P = 0.0001) and 27% (CI: 20-36)(P = 0.0001), respectively. Self-limited adverse events included dysuria (n = 13), hematuria (n = 6), hematospermia (n = 2), urinary frequency (n = 3) and retention (n = 2). No severe adverse events, nontarget embolization, or adverse effects on erectile function or sexual health. ConclusionThis prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.