Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study

Abstract

Purpose: To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).

Materials and methods: This was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.

Results: Four hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.

Conclusion: PAE is a safe and effective treatment for symptomatic BPH and LUTS. Level of Evidence Level 3 Trial registration ClinicalTrials.gov NCT03527589.

Keywords: Acute urinary retention; Benign prostatic hyperplasia; Embosphere® Microspheres; International Prostate Symptom Score (IPSS); Lower urinary tract symptoms; Prostatic artery embolization; Quality of life; Sexual Health Inventory for Men (SHIM).

Fig. 1

Patient flow diagram AUR, acute urinary retention; LUTS,  lower urinary tract symptoms; PAE, prostatic artery embolization

Fig. 2

Changes in IPSS, QoL^a, and clinical characteristics of patients with bothersome LUTS. IPSS,  International Prostate Symptom Score; LUTS, lower urinary tract symptoms; PVR, post-void residual; Qmax, maximum urinary flow rate; QoL, quality of life; SHIM, Sexual Health Inventory for Men ^aQoL score is based on a single question within the IPSS assessment that asks patients “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”, scores are graded based on the following 0 (delighted), 1 (pleased), 2 (mostly satisfied), 3 (mixed about equally satisfied and dissatisfied), 5 (mostly dissatisfied), and 6 (terrible)