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一项为期3个月的临床前试验,旨在评估一种新型类似经阴道无张力尿道中段悬吊带术(TVT)的网片(TVTx)在绵羊模型中的性能。

A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model.

作者信息

Rezapour Masoumeh, Novara Giacomo, Meier Peter A, Holste Joerg, Landgrebe Susanne, Artibani Walter

机构信息

Department of Women's and Children's Health Obstetrics and Gynecology, Uppsala University, Uppsala, Sweden.

出版信息

Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):183-7. doi: 10.1007/s00192-006-0130-x. Epub 2006 Apr 21.

DOI:10.1007/s00192-006-0130-x
PMID:16628374
Abstract

The objective of this study was to evaluate in a sheep model the performance of a new polypropylene mesh (TVTx), which is intended as a less invasive treatment for female stress urinary incontinence. Eight female sheep were used in this study, each one being implanted with eight TVTx samples. At each time-point (weeks 1, 2, 4, and 12) seven TVTx were pulled out, while one TVTx was carefully dissected for histological investigations. One TVTx and one TVT, moreover, were inserted and immediately pulled out for obtaining the initial pullout forces in all sheep. The initial pullout values of TVT and TVTx were overlapping. The pullout forces of TVTx were >5 N (500 g) and increasing from weeks 1 to 12 (p<0.001). Histology revealed good tissue integration of TVTx in the tissue within 12 weeks after implantation. No abnormal histological findings were observed. This data could support the realization of a clinical trial with the TVTx mesh.

摘要

本研究的目的是在绵羊模型中评估一种新型聚丙烯网片(TVTx)的性能,该网片旨在作为女性压力性尿失禁的一种侵入性较小的治疗方法。本研究使用了8只雌性绵羊,每只绵羊植入8个TVTx样本。在每个时间点(第1、2、4和12周),取出7个TVTx,同时小心解剖1个TVTx用于组织学研究。此外,在所有绵羊中插入1个TVTx和1个TVT并立即取出,以获得初始拔出力。TVT和TVTx的初始拔出值重叠。TVTx的拔出力>5 N(500 g),且从第1周到第12周逐渐增加(p<0.001)。组织学显示TVTx在植入后12周内与组织有良好的组织整合。未观察到异常组织学发现。这些数据可为使用TVTx网片进行临床试验提供支持。

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TVT-S in the U position--anatomical study.U 形位置的经闭孔无张力尿道中段悬吊术——解剖学研究
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