Effects of an Anal Insert Device in Fecal Incontinence

Inclusion Criteria * Able to provide signed (written) informed consent * Diagnosis of fecal incontinence, with duration of symptoms six months or longer with a history of at least one fecal incontinence (FI) episode per week or at least four episodes per month * Subject comprehends study meaning and is capable of carrying out study duties * Patient is fluent in English as study questionnaires have been validated using English * If female and of childbearing potential, patient has had a negative urine pregnancy test within 21 days of the first day of the baseline visit * If applicable, patient agrees to use acceptable birth control (surgical sterilization, abstinence, approved hormonal contraceptives such as birth control pills, barrier methods such as condom or diaphragm used with a spermicide, or an intrauterine device (IUD)). If not applicable, the reason why shall be documented on the screening log. * Subject is at least 18 years of age at time of consent * Patients has failed conservative medical therapy (i.e., the use of bulking agents, anti-diarrheal agents (e.g., loperamide) and biofeedback therapy as appropriate) for Fecal Incontinence Exclusion Criteria * Unable or unwilling to provide informed consent or to comply with study procedures * History of anorectal pathology in the past 6 months (perianal abscess or fistula, fecal impaction, or clinically significant rectocele). * History of inflammatory bowel disease with active proctosigmoiditis * History of rectal su…