van Kollenburg Rob A A, van Riel Luigi A M J G, Bloemen Paul R, Oddens Jorg R, de Reijke Theo M, Beerlage Harrie P, de Bruin Daniel Martijn
Department of Urology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
Department of Biomedical Engineering & Physics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.
JMIR Res Protoc. 2020 Jan 21;9(1):e15687. doi: 10.2196/15687.
Standard surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) use a transurethral approach. Drawbacks are the need for general or spinal anesthesia and complications such as hematuria, strictures, and cloth retention. Therefore, a minimal invasive technique under local anesthesia is desired to improve patient safety. Recently, SoracteLite transperineal laser ablation (TPLA) has been introduced as a novel minimal invasive treatment for BPO. The system used is unique because 4 laser sources are independently available. This 1064-nm diode laser induces coagulative necrosis. Moreover, TPLA is unique because it has a transperineal approach and can be performed under local anesthesia in an outpatient setting.
The primary objective of this study is to determine the safety and feasibility of TPLA treatment for men, who are fit for standard surgery, with LUTS due to BPO. The secondary objectives are to determine functional outcomes by flowmetry and patient-reported outcome measures (PROMs), side effects, and tissue changes observed on imaging.
This study is a prospective, single center, interventional pilot study IDEAL framework stage 2a and will include 20 patients. Eligible patients are men ≥40 years of age, with a prostate volume of 30 to 120 cc, have urodynamically proven bladder outlet obstruction, and have a peak urinary flow of 5 to 15 mL per second. All patients will undergo TPLA of their prostate under local anesthesia by using the EchoLaser system. Depending on the prostate volume, 2 to 4 laser fibers will be placed bilaterally into the prostate. Patient follow-up consists of uroflowmetry, PROMs, and imaging by using contrast-enhanced ultrasound. Total follow-up is 12 months following treatment.
Presently, recruitment of patients is ongoing. Publication of first results is expected by early 2020.
TPLA offers the potential to be a novel minimal invasive technique for treatment of LUTS due to BPO in men fit for standard desobstruction. This study will evaluate the safety and feasibility of TPLA and report on functional outcomes and tissue changes observed on imaging following TPLA treatment.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15687.
因良性前列腺梗阻（BPO）导致的下尿路症状（LUTS）的标准外科治疗采用经尿道入路。缺点是需要全身麻醉或脊髓麻醉以及诸如血尿、尿道狭窄和膀胱结石残留等并发症。因此，需要一种局部麻醉下的微创技术来提高患者安全性。最近，SoracteLite经会阴激光消融术（TPLA）已被引入作为一种新型的BPO微创治疗方法。所使用的系统很独特，因为有4个激光源可独立使用。这种1064纳米二极管激光会引发凝固性坏死。此外，TPLA很独特，因为它采用经会阴入路，并且可以在门诊环境下局部麻醉下进行。
本研究的主要目的是确定TPLA治疗适合标准手术、因BPO导致LUTS的男性患者的安全性和可行性。次要目的是通过尿流率测定和患者报告结局指标（PROMs）确定功能结局、副作用以及影像学观察到的组织变化。
本研究是一项前瞻性、单中心、干预性试点研究，处于IDEAL框架的2a阶段，将纳入20名患者。符合条件的患者为年龄≥40岁、前列腺体积为30至120立方厘米、经尿动力学证实有膀胱出口梗阻且最大尿流率为每秒5至15毫升的男性。所有患者将使用EchoLaser系统在局部麻醉下接受前列腺TPLA治疗。根据前列腺体积，双侧将2至4根激光光纤置入前列腺。患者随访包括尿流率测定、PROMs以及使用对比增强超声进行影像学检查。治疗后总随访时间为12个月。
目前，患者招募正在进行中。预计2020年初公布首批结果。
TPLA有可能成为一种新型微创技术，用于治疗适合标准解除梗阻治疗的男性因BPO导致的LUTS。本研究将评估TPLA的安全性和可行性，并报告TPLA治疗后功能结局和影像学观察到的组织变化。
国际注册报告识别码（IRRID）：DERR1-10.2196/15687。
