Fujihara Atsuko, Shiraishi Takumi, Miyashita Masatsugu, Inoue Yuta, Saito Yumiko, Taga Hideto, Naitoh Yasuyuki, Iwami Yayoi, Horiguchi Go, Ito-Ihara Toshiko, Ukimura Osamu
Department of Urology.
The Clinical and Translational Research Center, University Hospital.
Int J Surg Protoc. 2024 Oct 30;28(4):1-6. doi: 10.1097/SP9.0000000000000031. eCollection 2024 Oct 21.
After robot-assisted laparoscopic radical prostatectomy (RARP) for localized prostate cancer, post-operative stress urinary incontinence (SUI) impacts patient quality-of-life (QOL). A simple and less invasive treatment for SUI in these patients is urgently needed. Deflux is a viscous gel that consists of a mixture of sodium hyaluronate and dextranomer beads. It is administered by transurethral approach for the treatment of vesicoureteral reflux. In this study, we aim to establish a minimally invasive treatment for post-prostatectomy SUI through transurethral Deflux injection.
We will perform a single-center, exploratory clinical trial to evaluate the safety and efficacy of transurethral injection of Deflux for SUI after RARP. Inclusion criteria are patients with SUI, a urine leakage volume between 15 and 500 g in a 24-h pad test, and those who use more than two pads per day. Five patients are scheduled to be enrolled in this pilot study. Deflux is injected endoscopically at the 3 o'clock and 9 o'clock positions in the submucosa until coaptation of submucosal bulking is achieved from both intraurethral sides. The primary endpoint is safety following Deflux injection. The secondary endpoint is efficacy on both SUI volume and patients' QOL.
The importance of this clinical trial is to propose a new minimally invasive treatment option for male SUI patients after RARP.
对于局限性前列腺癌患者，在接受机器人辅助腹腔镜根治性前列腺切除术（RARP）后，术后压力性尿失禁（SUI）会影响患者的生活质量（QOL）。迫切需要一种针对这些患者SUI的简单且侵入性较小的治疗方法。Deflux是一种粘性凝胶，由透明质酸钠和葡聚糖微球混合而成。它通过经尿道途径给药用于治疗膀胱输尿管反流。在本研究中，我们旨在通过经尿道注射Deflux建立一种针对前列腺切除术后SUI的微创治疗方法。
我们将进行一项单中心探索性临床试验，以评估经尿道注射Deflux治疗RARP术后SUI的安全性和有效性。纳入标准为患有SUI、24小时尿垫试验漏尿量在15至500克之间且每天使用超过两片尿垫的患者。计划招募五名患者参与这项初步研究。在内镜下于黏膜下层3点和9点位置注射Deflux，直至从尿道两侧实现黏膜下填充的贴合。主要终点是Deflux注射后的安全性。次要终点是对SUI量和患者QOL的疗效。
这项临床试验的重要性在于为RARP术后男性SUI患者提出一种新的微创治疗选择。
