Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.
研究概览
简要总结
This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical and urodynamic for stress urinary
排除标准
- •Detrusor overactivity (urodynamic study)
- •Urodynamic changes suggesting reduced vesical capacity
- •Associated neurological diseases
- •Coagulopathies
- •Pregnancy
- •Foreign matter sensitiveness history
- •Acute urinary tract infection
- •Sequel from high ionizing radiation exposure
- •Use of drugs that may result in high surgical risk and/or significant postoperative complication
- •Anesthetic procedure contraindication
- •Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported
研究组 & 干预措施
TVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
干预措施: TVT-O (Device)
TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
干预措施: TVT-S (Device)
结局指标
主要结局
Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Ana Maria Homem de Mello Bianchi
MD
Federal University of São Paulo