A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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