OBJECTIVES Assessing medium-term functional results of a novel minimally-invasive treatment for lower urinary tract symptoms due to BPO with the second generation of the temporary implantable nitinol device (iTind; Medi-Tate Ltd®, Israel): 2-year follow-up of a single-arm, prospective, international multicenter study. Further, we aimed to identify preoperative baseline parameters predicting response to iTind treatment. METHODS Following local ethical committee approval in every participating centre, 81 men with symptomatic BPO (IPSS ≥ 10, peak urinary flow < 12 ml/s, and prostate volume < 75 ml) were enrolled in this study. Patients with PVR > 250 ml, obstructive median lobe, previous prostatic surgery, confounding bladder or sphincter dysfunction based on medical history, active urinary infection and unable to interrupt antithrombotic or antiplatelet treatment were exclusion criteria. A wash-out period of 1 month for alpha-blockers and 6 months for 5-ARIs was mandatory to avoid confounders. The procedure was performed as previously described: implantation under light sedation and removal 5-7 days later with topical sedation. Patients were assessed for perioperative results including OR-time, pain (VAS) and complications (Clavien-Dindo-Grading System); and for functional results (PVR, Qmax, IPSS) and quality of life (QoL) including sexual and ejaculatory function using two yes/no questions. Follow-up assessments were done at 1, 3, and 6 months, and 1 and 2 years. RESULTS Of the 81 patients initially enrolled in this study, follow-up included 67 men at 1 year and 51 men at 2 years. For the 51 men included in the present analysis, the median age was 65 years, median prostate volume 37 ml (range 16-65 ml). Baseline values for IPSS and QoL were 20.51 ± 4.58, 3.96 ± 0.87. Qmax and PVR were 7.62 ± 2.25 ml/s and 65.84 ± 38.46, respectively. No intraoperative complications were observed and the average pain level recorded on the visual analogue scale (VAS) was 3.2 ± 1.6. A significant reduction in symptoms and improvement in urinary flow was observed (p < 0.0001) at all assessment points: IPSS-score and QoL improved to 8.51 ± 5.51 and 1.76 ± 1.32, respectively; and Qmax increased to 16.00 ± 7.43 ml/s. None of the patients who were previously sexually active reported a deterioration in sexual or ejaculatory functions according to two yes/no questions over the follow-up period. Excluding the patients lost at follow-up, five patients underwent surgery between 12 and 24 months. Upon investigation, it was discovered that four of the five patients requiring surgery had median lobes and were protocol deviators. A failure analysis was carried out for all 81 patients in order to identify baseline parameters that could predict treatment failure. 58.33% of patients in the failure group (7 out of 12) had median lobes which was found to be statistically significant (p < 0.0001). None of the other preoperative variables (age, prostate volume, IPSS scores, Qmax, PVR, and PSA) were found to predict response to iTind treatment. CONCLUSION iTind treatment for BPO-related LUTS showed marked and durable reduction in symptoms and improvement of functional parameters and quality of life at 24 months of follow-up. It was found that median lobe may predict failure of iTind treatment. According to the yes/no questions, ejaculatory and sexual functions do not seem to be effected following treatment, however, this finding must be supported with further studies using the accepted tools.

中文翻译：

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患有LUTS的男性的第二代临时植入式镍钛合金装置（iTind）：MT-02研究的2年结果。

目的使用第二代临时植入式镍钛诺装置（iTind； Medi-TateLtd®，以色列）评估新型的微创治疗BPO引起的下尿路症状的中期功能结果：2年随访单臂，前瞻性国际多中心研究。此外，我们旨在确定术前基线参数，以预测对iTind治疗的反应。方法在每个参与中心的地方伦理委员会批准后，本研究纳入了81名有症状BPO（IPSS≥10，尿流峰值<12 ml / s，前列腺体积<75 ml）的男性。PVR> 250 ml，正中叶阻塞，先前进行过前列腺手术，根据病史混淆了膀胱或括约肌功能障碍的患者，活动性尿路感染和不能中断抗血栓或抗血小板治疗是排除标准。为避免混杂因素，α-受体阻滞剂的清洗期为1个月，5-ARIs的清洗期为6个月。该过程如前所述进行：在轻度镇静下植入，并在5-7天后局部镇静取出。对患者的围手术期结果进行了评估，包括手术时间，疼痛（VAS）和并发症（Clavien-Dindo评分系统）；对于功能结果（PVR，Qmax，IPSS）和生活质量（QoL），包括性和射精功能，使用两个是/否问题。在1、3和6个月以及1和2年进行随访评估。结果最初纳入该研究的81名患者中，随访包括1岁时67例男性和2岁时51例男性。对于本分析中包括的51名男性，中位年龄为65岁，中位前列腺体积为37毫升（范围为16-65毫升）。IPSS和QoL的基线值为20.51±4.58、3.96±0.87。Qmax和PVR分别为7.62±2.25 ml / s和65.84±38.46。没有观察到术中并发症，在视觉模拟量表（VAS）上记录的平均疼痛水平为3.2±1.6。在所有评估点均观察到症状显着减轻和尿流改善（p <0.0001）：IPSS评分和QoL分别改善至8.51±5.51和1.76±1.32；和Qmax增加到16.00±7.43 ml / s。在随访期内，根据两个是/否的问题，以前没有性活动的患者均未报告性或射精功能恶化。排除随访中丢失的患者，五名患者在12到24个月内接受了手术。经调查，发现需要手术的五位患者中有四位具有正中叶并且是方案偏离者。对所有81例患者进行了失败分析，以确定可以预测治疗失败的基线参数。衰竭组中58.33％的患者（12个中有7个）的中叶呈统计学意义（p <0.0001）。没有发现其他术前变量（年龄，前列腺体积，IPSS评分，Qmax，PVR和PSA）可预测对iTind治疗的反应。结论iTind治疗BPO相关性LUTS在随访24个月时显示出明显且持久的症状减轻，功能参数和生活质量的改善。发现中叶可能预示iTind治疗失败。根据是/否的问题，射精和性功能似乎在治疗后不会受到影响，但是，必须使用接受的工具进行进一步的研究来支持这一发现。