NCT00453739已完成不适用
TVT-World Wide Observational Registry for Long-Term Data
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,407
- 试验地点
- 30
- 主要终点
- Standing cough stress test
研究概览
简要总结
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.
详细描述
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
排除标准
- 未提供
结局指标
主要结局
Standing cough stress test
时间窗: 12 months
次要结局
- I-QOL score(3, 6, 12 and 24 months)
研究者
研究点 (30)
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