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临床试验/NCT01982188
NCT01982188已完成不适用

Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Cough Stress Test

研究概览

简要总结

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period

排除标准

  • previous surgical treatment for stress urinary incontinence (SUI)

结局指标

主要结局

Cough Stress Test

时间窗: 12 months post procedure

Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.

次要结局

  • Urinary Impact Questionnaire (UIQ-7)(baseline and 12 months postoperatively)
  • Sandvick Severity Index Questionnaire(baseline and 12 months postoperatively)
  • mesh related complications(12 months post procedure)
  • Urinary Distress Inventory 6 (UDI-6)(baseline and 12 months postoperatively)

研究者

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

charbel salamon

Principal Investigator

Atlantic Health System

研究点 (1)

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