BACKGROUND: Magnetic sphincter augmentation, a successful treatment of gastroesophageal reflux disease, has been applied to treat fecal incontinence. The purpose of this feasibility study was to understand the safety profile as well as the potential benefit of this new device when it is implanted in patients with fecal incontinence.
METHODS: A magnetic anal sphincter device was surgically implanted in candidates with documented fecal incontinence of more than 2 episodes per week at 3 investigational centers in Europe and the United States following ethics/institutional review board approval. The magnetic anal sphincter device was placed around the anal canal via a single anterior incision. All data were collected prospectively. The primary outcome measure was the reduction of incontinent episodes based on a daily continence diary.
RESULTS: To date 14 patients have been implanted with the device (all female; mean age, 62.8 y; range, 41–74 y) with a median follow-up of 6 months. There have been no intraoperative complications. Mean hospital stay was 3 days; range, 1 to 7 days. Adverse events were observed in 7 patients. Three patients are no longer implanted with a device; 2 devices were removed and one passed spontaneously following a separation at the suture connection. Five patients with 6-month follow-up demonstrated a mean reduction in the number of average weekly incontinence episodes from 7.2 to 0.7 (90.9%) and a mean reduction in Wexner Continence Score from 17.2 to 7.8 (54.7%). Compared with baseline, quality of life improved in all 4 domains of the fecal incontinence quality of life (FIQoL) scoring system. No patients have reported that their condition has worsened. Two patients at 1-year follow-up both reported perfect continence.
CONCLUSION: This preliminary study describes the use of a new device to treat fecal incontinence. Compared with existing devices, implantation is simple and it requires no adjustments from the physician or patient once the device is implanted. Initial assessment with a small number of patients shows promising outcomes with a limited incidence of complications and good restoration of continence.
1Department of Digestive and Endocrine Surgery, University Hospital of Nantes, Nantes, France
2Providence Sacred Heart Medical Center, Spokane, Washington
3Department of Surgery, Aarhus University Hospital, Aarhus, Denmark
4Colon and Rectal Surgery Associates, Minneapolis, Minnesota
5Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, Minnesota
Financial Disclosure: All the participating institutions received financial support from Torax Medical, Inc. during this feasibility study. Dr. Madoff is a consultant for Torax Medical, Inc.
Presented at the meeting of The American Society of Colon and Rectal Surgeons, Minneapolis, MN, May 15 to 19, 2010.
Correspondence: P. A. Lehur, M.D., Ph.D., University Hospital of Nantes, 1 Place A Ricordeau, F44093 Nantes Cedex, France. E-mail: email@example.com