Department of Vascular and Oncological Interventional Radiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20 Rue Leblanc, 75015, Paris, France.
Department of Interventional Radiology, Miller School of Medicine, University of Miami, Miami, FL, USA.
Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4.
To describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).
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.
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.
PAE is a safe and effective treatment for symptomatic BPH and LUTS. Level of Evidence Level 3 Trial registration ClinicalTrials.gov NCT03527589.
描述前列腺动脉栓塞术（PAE）治疗后 24 个月良性前列腺增生（BPH）患者的临床结局。
这是一项针对具有下尿路症状（LUTS）或急性尿潴留（AUR）的 BPH 男性的国际、多中心、前瞻性试验，采用 PAE 治疗。主要结局是有症状 LUTS 患者的国际前列腺症状评分（IPSS）在 12 个月时的变化，或 AUR 患者的导尿管独立性。次要结局指标包括 IPSS 在 3 个月和 24 个月时的变化、生活质量（QoL）的变化、男性性健康问卷（SHIM）问卷的变化、技术成功率和不良事件（AEs）。数据使用描述性统计进行总结。
478 例连续患者接受了 PAE（有症状 LUTS：N=405；AUR：N=73），平均年龄为 70 岁。对于因有症状 LUTS 而接受治疗的患者，基线时的总 IPSS 平均为 21.8，分别在 PAE 后 3、12 和 24 个月时降至 9.3、10.6 和 11.2（均 P<0.001）；基线时的 QoL 为 4.7，分别在 3、12 和 24 个月时降至 2.0、2.1 和 2.3（均 P<0.001）。PAE 后 12 个月时的平均 SHIM 评分为 13.8。73 例因 AUR 而接受治疗的患者中，48 例（65.8%）在 PAE 后 3 个月内取出留置导尿管，24 个月时仍无需导尿管。55 例（11.5%）发生≥1 例 AE，10 例（2.1%）发生严重 AE。
PAE 是治疗有症状 BPH 和 LUTS 的安全有效方法。
3 级试验。
ClinicalTrials.gov NCT03527589。
