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Purpose <p>Our goal was to evaluate the feasibility, safety, and outcomes at 12&#xa0;months of prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer in patients with benign prostatic hyperplasia-related lower urinary tract symptoms.</p> Materials and Methods <p>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 &gt; 18 or a QoL score &gt; 2, and prostate volume &gt; 40&#xa0;mL. Exclusion criteria were prostate cancer, advanced atherosclerosis. Outcomes were assessed at 12&#xa0;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.</p> Results <p>Bilateral injection was performed in all patients. No patients experienced major adverse events. Compared to baseline, statistically significant improvements were observed at 12&#xa0;months for the IPSS (9.3 ± 7.8 vs. 17.9 ± 5.8; <i>P</i> = 0.03), IPSS-QoL (2.1 ± 1.9 vs. 4.8 ± 1.1; <i>P</i> = 0.01). No statistically significant improvements were observed at 12&#xa0;months for post-void residual volume (41.5 ± 54.96 vs. 57.3 ± 61.3; <i>P</i> = 0.9) and prostate volume (82.7 ± 46.6&#xa0;mL vs. 89.2 ± 34.1&#xa0;mL; <i>P</i> = 0.6).</p> Conclusions <p>Prostatic artery embolization with Ethylene Vinyl Alcohol Copolymer is safe. This method provides good outcomes at 12&#xa0;months, but no effect on the prostate volume and post-void residual volume. It deserves further evaluation in randomised trials with longer follow-up.</p> Trial Registration <p>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, <a href="http://clinicaltrials.gov/study/NCT05395299?cond=embolization&amp;term&amp;rank=1">http://clinicaltrials.gov/study/NCT05395299?cond=embolization&amp;term&amp;rank=1</a>).</p> Graphical Abstract <p></p>

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Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis

  • 期刊论文

  • 发表日期：

    2025年8月13日

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  • Jacques Sédat,
  • Eric Fontas,
  • Paolo Arnoffi,
  • Giuseppe Stranieri,
  • Frederic Colomb,
  • Yves Chau

摘要

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).

Graphical Abstract