Department of Urology, Ospedale Sant'Andrea, La Sapienza University, Rome, Italy.
Azienda Ospedaliero-Universitaria Mater Domini, Magna Graecia University of Catanzaro, Catanzaro, Italy.
World J Urol. 2021 Jun;39(6):2037-2042. doi: 10.1007/s00345-020-03418-2. Epub 2020 Aug 26.
To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Men with symptomatic BPH (IPSS ≥ 10, Q < 12 ml/s, and prostate volume (PV) < 120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5-7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM questionnaires. Post-operative IPSS, QoL, Q and PVR were also assessed at 1, 3, and 6 months post-operatively.
This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15-80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average post-operative VAS score was 3.24 ± 2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM and MSHQ-EjD questionnaires and significant improvements (p < 0.0001) from baseline levels were recorded in IPSS, QoL and peak flow.
iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.
评估暂时性植入钕钛诺装置（iTind；Medi-Tate Ltd，以色列）治疗良性前列腺增生（BPH）相关下尿路症状（LUTS）后与保留尿控和性功能相关的功能结果。
患有症状性 BPH（国际前列腺症状评分（IPSS）≥10、Q<12 ml/s 和前列腺体积（PV）<120 ml）的男性被邀请参加这项单臂、前瞻性多中心研究（MT06）。在进行该程序之前，患者未停止使用 BPH 药物。iTind 在静脉镇静下通过 22F 刚性膀胱镜植入，5-7 天后通过局部麻醉下的 22F Foley 导管取出。记录术后视觉模拟评分（VAS）和并发症（Clavien Dindo-Grading 系统）。根据国际尿控协会（ICS）、男性健康问卷（MSHQ-EjD）和勃起功能国际指数（SHIM）问卷评估尿控和勃起及射精功能的保留情况。术后 1、3 和 6 个月还评估了 IPSS、生活质量（QoL）、Q 和 PVR。
本中期报告包括研究中前 70 名入组患者的 6 个月随访数据。中位年龄为 62.31 岁，平均前列腺体积为 37.68 ml（15-80 ml）。表 1 报告了基线和随访数据。未观察到术中并发症，术后平均 VAS 评分为 3.24±2.56。平均而言，在取回程序后 4.3 天，患者即可恢复日常生活。根据 ICS、SHIM 和 MSHQ-EjD 问卷，所有受试者的性功能和尿控均得到保留，IPSS、QoL 和峰值流量均记录到显著改善（p<0.0001）。
iTind 是一种耐受良好的微创治疗 BPH 相关 LUTS 的方法，可保留性功能和尿控，快速恢复和回归日常生活，在 6 个月随访时显著改善症状和尿流。
