PURPOSE To investigate the effectiveness and safety of SoracteLite™-transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. METHODS Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLiteTM TPLA treatment. Secondary end-point was the assessment of complications. RESULTS Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P < 0.001), PVR from 89.5 ± 84.6 to 27.2 ± 44.5 ml (P < 0.001), Qmax from 8.0 ± 3.8 to 14.3 ± 3.9 ml/s (P < 0.001), QoL from 4.5 ± 1.1 to 1.8 ± 1.0 (P < 0.001), volume from 75.0 ± 32.4 to 60.3 ± 24.5 ml (P < 0.001). At 12 months, IPSS improved from 22.5 ± 4.5 to 7.0 ± 2.9 (P < 0.001), PVR from 71.7 ± 93.9 to 17.8 ± 51.0 ml (P < 0.001), Qmax from 8.6 ± 5.2 to 15.0 ± 4.0 ml/s (P < 0.001), QoL from 4.2 ± 0.6 to 1.6 ± 0.9 (P < 0.001), volume from 87.9 ± 31.6 to 58.8 ± 22.9 ml (P < 0.001). 7/160 (4.3%) grade I and 1/160 (0.6%) grade III complication occurred. CONCLUSIONS SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months.

中文翻译：

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经会阴激光消融用于经皮治疗良性前列腺增生：可行性研究。一项回顾性多中心研究在6和12个月时得出的结果。

目的研究随访6个月和12个月时SoracteLite™-经会阴经皮激光消融术（TPLA）在有症状的良性前列腺增生症（BPH）患者中的有效性和安全性。方法在四个中心的局麻下对伴有BPH继发性泌尿症状的患者进行TPLA。在美国的指导下，在前列腺组织中最多插入了四个21G涂药器。每种治疗均使用工作在1064 nm的二极管激光器进行，根据前列腺大小改变照明时间。这项研究的主要终点是SoracteLiteTM TPLA治疗后6个月和12个月时IPSS，PVR，Qmax，QoL和前列腺体积的变化。次要终点是并发症的评估。结果对数据160例患者进行了分析（平均年龄69.8±9）。随访至少6个月的患者为6年，随访83例，平均随访时间为12个月的83例患者（平均年龄67.9±8.7岁）。在6个月时，IPSS从22.5±5.1升至7.7±3.3（P <0.001），PVR从89.5±84.6升至27.2±44.5 ml（P <0.001），Qmax从8.0±3.8增至14.3±3.9 ml / s（P <0.001），QoL从4.5±1.1到1.8±1.0（P <0.001），体积从75.0±32.4到60.3±24.5 ml（P <0.001）。在12个月时，IPSS从22.5±4.5改善至7.0±2.9（P <0.001），PVR从71.7±93.9改善至17.8±51.0 ml（P <0.001），Qmax从8.6±5.2改善至15.0±4.0 ml / s（P <0.001），QoL从4.2±0.6到1.6±0.9（P <0.001），体积从87.9±31.6到58.8±22.9 ml（P <0.001）。发生了7/160（4.3％）的I级和1/160（0.6％）的III级并发症。结论SoracteLite™TPLA可以显着改善IPSS，Qol，Qmax，PVR，