he Fenix System was studied in 35 adults who failed conventional medical therapy for treating fecal incontinence. Study evaluations were performed before and after the procedure and at six weeks, three months, six months and 12 months post-implant. The 15 participants studied at U.S. sites will have annual evaluations until five years after the device was implanted.
Probable benefits were evaluated using a bowel diary to track fecal incontinence events and by a validated, disease-specific questionnaire called the Fecal Incontinence Quality of Life Scales to quantify changes in quality of life before and after implantation of the Fenix System. After 12 months, 62.9 percent of participants experienced a reduction of fecal incontinence episodes by half or more; 54.3 percent experienced a reduction in fecal incontinence days by half or more; and 37.1 percent experienced a reduction in urgent episodes by half or more. Study participants also showed improvements in quality of life measures including improvements in depression, self-perception, and feelings of embarrassment. These results suggest that patients with fecal incontinence could benefit from the device when they have failed other fecal incontinence therapies.