前瞻性随机多中心研究评估钬激光与新型铥纤维激光用于前列腺剜除术。

Prospective randomized multicenter study to evaluate holmium vs. new thulium fiber laser for prostate enucleation.

机构信息

Department of Urology, HM Sanchinarro University Hospital, HM Hospitales, Instituto de Investigación Sanitaria HM Hospitales and ROC Clinic, Universidad Camilo José Cela, Villafranca del Castillo, Madrid, Spain -

出版信息

Minerva Urol Nephrol. 2024 Aug;76(4):491-498. doi: 10.23736/S2724-6051.24.05706-9.

DOI:10.23736/S2724-6051.24.05706-9

PMID:39051894

Abstract

BACKGROUND

Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes.

METHODS

A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications.

RESULTS

Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Qmax), and post-void residual volume (PVR; P<0.05). At 6 months, mean±SD IPSS, IPSS-QoL, Qmax, and PVR for HoLEP vs. ThuFLEP were 5.8±4.9 vs. 4.8±5.0 points (P=0.57), 1.6±1.4 vs. 0.7±1.1 points (P=0.09), 29.9±12.5 vs. 29.6±8.0 mL/s (P=0.8), and 16.3±17.7 vs. 15.5±13.4 mL (P=0.92), respectively. No intraoperative complication was recorded. No Clavien-Dindo ≥III complications occurred during hospitalization. After 6 months, 8 (8%) and 6 (6%) patients reported mild stress urinary incontinence in HoLEP and ThuFLEP groups, respectively (P=0.24). Urethral stenosis was observed in 3 men (3%) in the HoLEP group and 1 subject (1%) in the ThuFLEP group (P=0.72).

CONCLUSIONS

HoLEP and ThuFLEP are effective and safe for BPH treatment, with comparable functional outcomes and complication rates at 6 months. Further research is needed to confirm these findings.

摘要

背景

良性前列腺增生（BPH）常导致男性下尿路症状（LUTS）。钬激光前列腺剜除术（HoLEP）和铥激光前列腺剜除术（ThuLEP）是治疗 BPH 的成熟技术。铥光纤激光前列腺剜除术（ThuFLEP）显示出良好的效果。

方法

进行了一项前瞻性随机多中心研究。纳入对药物治疗无反应的 BPH 和 LUTS 患者。记录术前、手术、围手术期和术后数据，并在 3 个月和 6 个月时进行随访。主要结局为功能改善，次要结局为并发症方面的安全性。

结果

共纳入 200 例患者（HoLEP 组 100 例，ThuFLEP 组 100 例）。两组间无显著基线差异。在 3 个月和 6 个月时，我们发现 HoLEP 和 ThuFLEP 两组的疗效均有统计学意义的改善：国际前列腺症状评分（IPSS）、IPSS 生活质量评分（QoL）、最大尿流率（Qmax）和剩余尿量（PVR；P<0.05）。在 6 个月时，HoLEP 组和 ThuFLEP 组的平均±SD IPSS、IPSS-QoL、Qmax和 PVR 分别为 5.8±4.9 与 4.8±5.0 分（P=0.57）、1.6±1.4 与 0.7±1.1 分（P=0.09）、29.9±12.5 与 29.6±8.0 mL/s（P=0.8）和 16.3±17.7 与 15.5±13.4 mL（P=0.92）。术中未记录并发症。住院期间无 Clavien-Dindo≥III 级并发症。6 个月后，HoLEP 组和 ThuFLEP 组分别有 8 例（8%）和 6 例（6%）患者报告轻度压力性尿失禁（P=0.24）。HoLEP 组有 3 例（3%）男性和 ThuFLEP 组有 1 例（1%）患者发生尿道狭窄（P=0.72）。