Who should be considered for prostate artery embolization: revisiting the urologic guidelines based on results from over 300 patients with benign prostatic hyperplasia.

Abstract

Background: Prostate artery embolization (PAE) has emerged as a minimally invasive therapy which affords improvement in benign prostatic hyperplasia (BPH) symptoms and objective urinary parameters with a favorable adverse event (AE) profile. While PAE was recently included in the American Urological Association (AUA) Guidelines, guidance on its specific use-cases is limited. This study sought to answer remaining questions surrounding the safety and efficacy of PAE across different patient subpopulations where formal guidance for PAE is limited.

Methods: Three hundred two patients with BPH underwent PAE. Key baseline characteristics were gathered. Patients were compared from baseline to follow-ups with regards to (1) objective parameters, including maximum urinary flow rate (Q_max), post-void residual (PVR), and prostate specific antigen (PSA); (2) prostate volume; (3) BPH symptoms, including International Prostate Symptom Score (IPSS), IPSS Quality-of-Life (IPSS-QoL), and BPH Impact Index (BPH-II); (4) sexual symptoms, including the International Index of Erectile function (IIEF) and Male Sexual Health Questionnaire for Ejaculatory Function Short Form (MSHQ-EjD-SF); and (5) AEs. Additional sub-analyses were performed comparing the safety/efficacy of PAE across key sub-groups.

Results: PAE afforded significant improvement (p < 0.05) in each subjective/objective BPH parameter and sexual function score at nearly all follow-up points. Specifically, IPSS improved by 12.3-13.8 points (52.8-59.2%); IPSS-QoL by 2.3-2.8 points (47.9-58.3%); IIEF by 3.2-5.7 points (15.6-27.8%); PSA by 1.5-2.0 ng/mL (15.6-28.5%); and prostate volume by 16.9%. Twelve (4.0%) AEs were reported; no sexual/severe AEs were observed. PAE was safe and afforded significant improvement in subjective/objective BPH parameters in patients with: prostate volumes ≥ 80 mL; prior BPH surgery/intervention; higher medical comorbidity; pre-procedural catheter-dependent urinary retention; pre-procedural renal insufficiency; and pre-procedural hematuria.

Conclusions: PAE improved subjective/objective BPH parameters and sexual function. Further, it safely afforded significant improvement in subjective/objective BPH parameters in specific contexts/scenarios where current guidance for PAE is limited, including patients with larger prostates, prior BPH intervention, higher medical comorbidity, urinary retention, renal insufficiency, and hematuria. Altogether, PAE can be performed safely and effectively in several real-world contexts in which formal guidance for PAE is limited, and where it may offer unique advantages compared to surgical therapies.

Trial registration: Clinicaltrials.gov, NCT03052049. Registered 6 September 2017, https://clinicaltrials.gov/study/NCT03052049 ; Clinicaltrials.gov, NCT02026908. Registered 10 June 2019, https://cdn.

Clinicaltrials: gov/large-docs/08/NCT02026908/Prot_SAP_000.pdf .