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临床试验/NCT00642109
NCT00642109终止不适用

A Prospective Randomized Clinical Trial: Comparison of the Retropubic (TVT) With the Transobturator (outside-in T.O.T. Monarc or Inside-out TVT-O) Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

David Scheiner1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2006年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
160
试验地点
1
主要终点
Urodynamic stress urinary incontinence measurement

研究概览

简要总结

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

  • Trial with surgical intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
  • •With or without concomitant surgery for pelvic organ prolapse
  • •With or without hysterectomy

排除标准

  • •No informed consent
  • •No preoperative urodynamic investigation
  • •Mixed urinary incontinence with predominant overactive bladder
  • •Recurrent stress urinary incontinence after sling procedure
  • •Begin of treatment of overactive bladder less then a month ago or non stable condition
  • •Pregnancy
  • •Desires future childbearing
  • •Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
  • •Preoperative postvoid residual urinary volume exceeding 100cc
  • •Coagulopathies

研究组 & 干预措施

TVT

Other

Tension-free Vaginal Tape (TVT)

干预措施: midurethral sling procedure (Procedure)

TOT

Other

Transobturator Tape outside-in (TOT Monarc)

干预措施: midurethral sling procedure (Procedure)

TVT-O

Other

Transobturator Tape inside-out (TVT-O)

干预措施: midurethral sling procedure (Procedure)

结局指标

主要结局

Urodynamic stress urinary incontinence measurement

时间窗: December 2009

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Scheiner

PI

University of Zurich

研究点 (1)

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