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

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