A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 2
- 主要终点
- Safety and efficacy for incontinence and prolapse procedures.
研究概览
简要总结
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
详细描述
Urinary incontinence is the involuntary loss of urine and can affect both men and women throughout their lives. Women are more likely to develop incontinence as a result of pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US contributing to several different types of incontinence including :
- Urge - 30% of the market
- Stress - 30% of the market of which 85% are women
- Combination urge and stress - 40%
Despite advances in behavioral therapy, pharmacological advances as well as development of minimally invasive surgical procedures, only one out of every twelve people affected actually seek help.
Prolapse
Globally, approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence. The breakdown of treatments for uterovaginal prolapse includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subject must be female and >18 years of age.
- •Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.
排除标准
- •Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
- •Subjects who currently have an untreated urinary tract infection
- •Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
- •Subject is pregnant or desires future pregnancies.
结局指标
主要结局
Safety and efficacy for incontinence and prolapse procedures.
次要结局
- Quality of Life Improvement as determined by Questionnaire.