イハラ　トシコ   Toshiko Ito-Ihara   猪原　登志子    所属   川崎医科大学  医学部 応用医学　先端医療開発学    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Exploratory trial of urethral submucosa injection therapy of deflux for stress urinary incontinence after radical prostatectomy.
掲載誌名	正式名：International journal of surgery protocols 略　 称：Int J Surg Protoc ISSNコード：24683574/24683574
掲載区分	国外
巻・号・頁	28(4),pp.1-6
著者・共著者	Atsuko Fujihara, Takumi Shiraishi, Masatsugu Miyashita, Yuta Inoue, Yumiko Saito, Hideto Taga, Yasuyuki Naitoh, Yayoi Iwami, Go Horiguchi, Toshiko Ito-Ihara, Osamu Ukimura
発行年月	2024/10
概要	BACKGROUND: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.METHODS: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.DISCUSSION:The importance of this clinical trial is to propose a new minimally invasive treatment option for male SUI patients after RARP.
DOI	10.1097/SP9.0000000000000031
PMID	40453464