Catherine Matthews, MD - Division of Urogynecology and Reconstructive Pelvic Surgery
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.