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