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

Objective: To evaluate the safety and efficacy of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Methods: A 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 (Q _max ) ≤ 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 Q _max at baseline 1, 3, and 12 months) after PAE. Baseline and 6-month total prostate (TV) and central gland (CG) volumes were obtained. Results: 45 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), Q _max (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 Q _max (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. Conclusion: This prospective clinical trial demonstrates that PAE is safe and efficacious for BPH, with significant improvement in LUTS and reduction in TV and CG volumes.