NCT01655498已完成不适用
A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Frequency of FI Episodes
研究概览
简要总结
The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of FI for at least 6 months
- •Baseline diary requirement for min # of FI episodes in a two-week period
- •Ability to manage investigational device insertion and removal
- •Successful fitting of study device
- •Willing and able to give written informed consent to participate in the study
排除标准
- •Chronic rectal, anal or pelvic pain
- •Any vaginal prolapse that extends beyond the plane of the hymen.
- •Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer)
- •Congenital anorectal malformation
- •Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI
- •Inflammatory bowel disease
- •Presence of a vaginal, anal, rectal or urethral fistula or anastomosis
- •Presence of a vaginal, rectal or bladder tumor
- •Presence of an open wound or tear in the vagina or anus by exam
- •Presence or history of rectovaginal fistula
- •Atrophic vaginal tissue as determined by symptoms or visualization
- •Current vaginal or urinary infection requiring treatment
- •History of recurrent urinary or vaginal infections
- •Subject is currently pregnant or planning pregnancy in next 5 months
- •Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing
- •Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk
结局指标
主要结局
Frequency of FI Episodes
时间窗: 1 Month
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
次要结局
- Number of Incontinent Days(1 Month)
- Device-related Adverse Events(1month)
研究者
研究点 (2)
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