The LIFE study is a trial for women experiencing symptoms of FI. This study is evaluating the use of the investigational LivSure vaginal insert for the control of FI. The insert is non-surgical and does not contain drugs or hormones. It resides in a similar position as a diaphragm or tampon. Like a diaphragm, the device can be removed by the patient at any time. While in the vagina, the device supports the rectum in a way that may control bowel leakage. The purpose of this trial is to evaluate the safety and effectiveness of use of LivSure device for the treatment of female fecal incontinence as measured by a reduction in the number of episodes of FI and number of incontinent days.
Madhulika Varma, M.D.
Associate Professor & Chief,
Section of Colorectal Surgery
Division of General Surgery
- Female gender
- Age 19-75 years
- History of FI for at least 6 months
- Subject willing and able to give written informed consent to participate in the study