NCT00534365已完成3 期
A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 7
- 主要终点
- Subjective Cure of Urinary Incontinence at 12 Months After Surgery
研究概览
简要总结
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Urinary incontinence symptoms
- •Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- •Age of at least 21 years
- •Desires surgical correction of stress urinary incontinence
排除标准
- •Post-void residual volume >100cc
- •Detrusor overactivity on preoperative multichannel urodynamic testing
- •History of previous synthetic, biologic or fascial sub-urethral sling
- •Desires future childbearing
- •History of bleeding diathesis or current anti-coagulation therapy
- •Current genitourinary fistula or urethral diverticulum
- •Reversible cause of incontinence (i.e. drug effect)
- •Contraindication to surgery
研究组 & 干预措施
1
Active Comparator
Tension-free vaginal tape procedure (TVT)
干预措施: tension-free vaginal tape (Device)
2
Active Comparator
TVT-SECUR device
干预措施: TVT-SECUR device (Device)
结局指标
主要结局
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
时间窗: 12 months
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
次要结局
- Long Term Complications > 6 Weeks(6 weeks-12 months)
- Patient Global Impression Improvement(12 months)
- Post Operative Complications at 6 Week or Less(6 week)
- Incontinence Severity Index Score(12 months)
研究者
研究点 (7)
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