Cardiovascular and interventional radiology · 2025
Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis.
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Sédat Jacques, Fontas Eric, Arnoffi Paolo, Stranieri Giuseppe, Colomb Frederic, Chau Yves
Аннотация
PURPOSE: Our goal was to evaluate the feasibility, safety, and outcomes at 12 months of prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer in patients with benign prostatic hyperplasia-related lower urinary tract symptoms.
MATERIALS AND METHODS: This was a single-centre prospective study from November 2023 to November 2024 registered in clinical trials (IDRCB, 2021-AO29-56-35). Twelve consecutive patients were included. Inclusion criteria were an IPSS > 18 or a QoL score > 2, and prostate volume > 40 mL. Exclusion criteria were prostate cancer, advanced atherosclerosis. Outcomes were assessed at 12 months using the International Prostate Symptoms Score and associated quality-of-life score, prostate volume, and post-void residual volume. The overall evolution was analysed using a mixed-effects model with repeated measures.
RESULTS: Bilateral injection was performed in all patients. No patients experienced major adverse events. Compared to baseline, statistically significant improvements were observed at 12 months for the IPSS (9.3 ± 7.8 vs. 17.9 ± 5.8; P = 0.03), IPSS-QoL (2.1 ± 1.9 vs. 4.8 ± 1.1; P = 0.01). No statistically significant improvements were observed at 12 months for post-void residual volume (41.5 ± 54.96 vs. 57.3 ± 61.3; P = 0.9) and prostate volume (82.7 ± 46.6 mL vs. 89.2 ± 34.1 mL; P = 0.6).
CONCLUSIONS: Prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer is safe. This method provides good outcomes at 12 months, but no effect on the prostate volume and post-void residual volume. It deserves further evaluation in randomised trials with longer follow-up.
TRIAL REGISTRATION: This study was performed according to Good Clinical Practice requirements and the Helsinki Declaration and registered on Clinical Trials.gov (Trial registration: IDRCB, 2021-AO29-56-35. Registered 27 May 2022, http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 ).
MATERIALS AND METHODS: This was a single-centre prospective study from November 2023 to November 2024 registered in clinical trials (IDRCB, 2021-AO29-56-35). Twelve consecutive patients were included. Inclusion criteria were an IPSS > 18 or a QoL score > 2, and prostate volume > 40 mL. Exclusion criteria were prostate cancer, advanced atherosclerosis. Outcomes were assessed at 12 months using the International Prostate Symptoms Score and associated quality-of-life score, prostate volume, and post-void residual volume. The overall evolution was analysed using a mixed-effects model with repeated measures.
RESULTS: Bilateral injection was performed in all patients. No patients experienced major adverse events. Compared to baseline, statistically significant improvements were observed at 12 months for the IPSS (9.3 ± 7.8 vs. 17.9 ± 5.8; P = 0.03), IPSS-QoL (2.1 ± 1.9 vs. 4.8 ± 1.1; P = 0.01). No statistically significant improvements were observed at 12 months for post-void residual volume (41.5 ± 54.96 vs. 57.3 ± 61.3; P = 0.9) and prostate volume (82.7 ± 46.6 mL vs. 89.2 ± 34.1 mL; P = 0.6).
CONCLUSIONS: Prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer is safe. This method provides good outcomes at 12 months, but no effect on the prostate volume and post-void residual volume. It deserves further evaluation in randomised trials with longer follow-up.
TRIAL REGISTRATION: This study was performed according to Good Clinical Practice requirements and the Helsinki Declaration and registered on Clinical Trials.gov (Trial registration: IDRCB, 2021-AO29-56-35. Registered 27 May 2022, http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 ).