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

Abbreviated Inclusion Criteria:

- History of FI for at least 6 months

- Subject willing and able to give written informed consent to participate in the study

- Subject can read, write and communicate fluently in English

- Subject willing and able to comply with visit schedule

- Subject is able to physically manage the insertion and removal of the Insert

Abbreviated 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 FI 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