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临床试验/NCT02598245
NCT02598245Unknown不适用

Comparison of the Distance Between the Transobturator Tape (TOT) and the Urethra According to Two Different Placement Techniques of the Tape (TOT 8/4 vs TOT 6/3)

Klinikum der Universität Köln2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Distance between urethra and transobturator sling

研究概览

简要总结

Transobturator tapes (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

详细描述

Retrospective studies demonstrated that the distance between urethra and suburethral sling can vary considerably between 1 mm and 10 mm. In order to standardize the placement of the suburethral sling we choose two different distances between urethra and sling.

Transobturator tape (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final fixation of the sling and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

According to the used Hegar dilator sounds two different techniques are used:

TOT 8/4 or TOT 6/3.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • urinary incontinence

排除标准

  • previous TOT or TVT

结局指标

主要结局

Distance between urethra and transobturator sling

时间窗: 2 weeks

transvaginal ultrasound measurements

次要结局

  • Distance between urethra and transobturator sling(16 weeks)

研究者

发起方
Klinikum der Universität Köln
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Dr. Wolfram Jäger

Professor

Klinikum der Universität Köln

研究点 (2)

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