A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Exclusion Criteria

• •Vaginal childbirth within the last 18 months
• •Currently pregnant or planning pregnancy during the study period
• •Acute infections or genito-urinary injuries that would impact comfortable device use
• •Current treatment for Fecal Incontinence other than medical management
• •Removal or diversion of any portion of the bowel
• •Recent urogenital or colorectal surgeries
• •Chronic abdominal pain in absence of diarrhea
• •Chronic (\>6 mos) rectal, anal or pelvic pain
• •Chronic watery diarrhea, unmanageable by drugs or diet
• •Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
• •Rectal prolapse (mucosal or full thickness)
• •Grade III or IV hemorrhoids
• •Pelvic organ prolapse beyond the plane of the hymen
• •Concurrent use of intra-vaginal pessary or other device
• •Anal or pelvic malignancy within last 5 years
• •History of pelvic irradiation for cancer
• •Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk