Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
研究概览
详细说明
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:
- 20% - no treatment
- 20% - non surgical management (pessary)
- 60% - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600,000 surgeries performed globally to treat prolapse. These numbers are projected to increase due to rapid, easy, and less costly methods as well as new products that facilitate the easier procedures.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Connecticut
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Norwalk、Connecticut、美国、06856
- US Surgical
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject must be female and >18 years of age.
- Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Safety and efficacy for incontinence and prolapse procedures.
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次要结果测量
结果测量 |
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Quality of Life Improvement as determined by Questionnaire.
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合作者和调查者
调查人员
- 研究主任:Noreen A. Gannon、Medtronic - MITG
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Vaginal Sling的临床试验
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International Partnership for Microbicides, Inc.完全的
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Medical University of GrazMedical University of Vienna; Medical University Innsbruck; Klinikum Klagenfurt am Wörthersee; University... 和其他合作者未知