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Abstract：
OBJECTIVE: The solid-state Thulium laser (Tm: YAG) is a novel alternative to the widely used Holmium laser for endoscopic enucleation of the prostate (EEP) due to its relatively high peak power. The aim of this study was to examine the efficacy and safety of a new pulsed Tm: YAG laser in its first application in humans.
METHODS: Data were retrospectively collected for the first 103 patients who underwent EEP with a new pulsed solid-state Tm: YAG laser (Thulio®, Dornier MedTech Systems GmbH, Weßling, Germany). Peri- and postoperative data were assessed. Procedure-specific complications were graded using Clavien-Dindo Classifications (CDC). Patients were interviewed 15 months after the surgery to evaluate functional and long-term outcomes. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS®).
RESULTS: The mean preoperative prostate volume was 105.6 ± 55.0 ml. Median enucleation speed was 4.1 g per minute (range 1.1-9.7). Short-term postoperative complications occurred in 21 patients (20.4%), but no high-grade complications (CDC ≥ IV) were observed. Five patients suffered gross haematuria and required reintervention (CDC IIIb; 4.9%). After 15 months, 76 patients (73.8%) participated in the follow-up interview, where seven patients (9.2%) reported complications, including two reinterventions for urethral strictures (CDC IIIb; 2.6%). Most patients reported an improvement in continence (54.0%) and urine stream (93.4%), but no difference in erectile function (81.6%). No persistent dysuria was reported. Patient satisfaction with the surgery results was very high (96.1%).
CONCLUSIONS: Endoscopic enucleation of the prostate with the new pulsed solid-state Tm: YAG laser is a safe and effective option for surgical BPH treatment.
BACKGROUND: German Clinical Trials Register number: DRKS00031676. Registration date: 10 May 2023, retrospectively registered.
METHODS: Data were retrospectively collected for the first 103 patients who underwent EEP with a new pulsed solid-state Tm: YAG laser (Thulio®, Dornier MedTech Systems GmbH, Weßling, Germany). Peri- and postoperative data were assessed. Procedure-specific complications were graded using Clavien-Dindo Classifications (CDC). Patients were interviewed 15 months after the surgery to evaluate functional and long-term outcomes. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS®).
RESULTS: The mean preoperative prostate volume was 105.6 ± 55.0 ml. Median enucleation speed was 4.1 g per minute (range 1.1-9.7). Short-term postoperative complications occurred in 21 patients (20.4%), but no high-grade complications (CDC ≥ IV) were observed. Five patients suffered gross haematuria and required reintervention (CDC IIIb; 4.9%). After 15 months, 76 patients (73.8%) participated in the follow-up interview, where seven patients (9.2%) reported complications, including two reinterventions for urethral strictures (CDC IIIb; 2.6%). Most patients reported an improvement in continence (54.0%) and urine stream (93.4%), but no difference in erectile function (81.6%). No persistent dysuria was reported. Patient satisfaction with the surgery results was very high (96.1%).
CONCLUSIONS: Endoscopic enucleation of the prostate with the new pulsed solid-state Tm: YAG laser is a safe and effective option for surgical BPH treatment.
BACKGROUND: German Clinical Trials Register number: DRKS00031676. Registration date: 10 May 2023, retrospectively registered.
摘要：
目的：由于其相对较高的峰值功率，固态Thulium激光（Tm：YAG）是广泛用于内窥镜前列腺摘除术（EEP）的新型替代品。这项研究的目的是检查新型脉冲Tm：YAG激光在人类中的首次应用的有效性和安全性。
方法：回顾性收集了使用新的脉冲固态Tm：YAG激光（Thulio®，DornierMedTechSystemsGmbH,韦斯林,德国)。评估围手术期和术后数据。使用Clavien-Dindo分类（CDC）对手术特异性并发症进行分级。手术后15个月对患者进行访谈，以评估功能和长期结果。用社会科学统计软件包(SPSS®)进行统计分析。
结果：术前平均前列腺体积为105.6±55.0ml。中值去核速度为4.1g/分钟(范围1.1-9.7)。术后发生短期并发症21例(20.4%),但未观察到高级别并发症(CDC≥IV).五名患者患有严重血尿，需要再次干预（CDCIIIb；4.9％）。15个月后,76例（73.8%）患者参加了随访访谈，其中7名患者(9.2%)报告有并发症，包括两次尿道狭窄的再干预(CDCIIIb;2.6%)。大多数患者报告尿失禁(54.0%)和尿流(93.4%)有所改善，但勃起功能无差异(81.6%)。无持续性排尿困难报告。患者对手术结果的满意度很高（96.1%）。
结论：新型脉冲固体Tm:YAG激光内镜下前列腺摘除术是一种安全有效的前列腺增生症手术治疗方法。
背景：德国临床试验登记号：DRKS00031676。注册日期：2023年5月10日，追溯注册。
方法：回顾性收集了使用新的脉冲固态Tm：YAG激光（Thulio®，DornierMedTechSystemsGmbH,韦斯林,德国)。评估围手术期和术后数据。使用Clavien-Dindo分类（CDC）对手术特异性并发症进行分级。手术后15个月对患者进行访谈，以评估功能和长期结果。用社会科学统计软件包(SPSS®)进行统计分析。
结果：术前平均前列腺体积为105.6±55.0ml。中值去核速度为4.1g/分钟(范围1.1-9.7)。术后发生短期并发症21例(20.4%),但未观察到高级别并发症(CDC≥IV).五名患者患有严重血尿，需要再次干预（CDCIIIb；4.9％）。15个月后,76例（73.8%）患者参加了随访访谈，其中7名患者(9.2%)报告有并发症，包括两次尿道狭窄的再干预(CDCIIIb;2.6%)。大多数患者报告尿失禁(54.0%)和尿流(93.4%)有所改善，但勃起功能无差异(81.6%)。无持续性排尿困难报告。患者对手术结果的满意度很高（96.1%）。
结论：新型脉冲固体Tm:YAG激光内镜下前列腺摘除术是一种安全有效的前列腺增生症手术治疗方法。
背景：德国临床试验登记号：DRKS00031676。注册日期：2023年5月10日，追溯注册。
