Magnetic anal sphincter augmentation in patients with severe fecal incontinence.

BACKGROUND

Fecal incontinence is a common, distressing condition with limited surgical options.

OBJECTIVE

This study examines the results of magnetic sphincter augmentation in patients with severe fecal incontinence.

DESIGN

This was a single-center, prospective, nonrandomized investigation.

SETTING

This study was conducted in a private colorectal practice.

PATIENTS

The cohort included all of the patients implanted with magnetic sphincter augmentation between January 2012 and October 2013.

INTERVENTION

Magnetic sphincter augmentation was studied.

MAIN OUTCOME MEASURES

Adverse events, symptom severity, quality of life, bowel diary, and manometry data were collected.

RESULTS

Eighteen patients (15 women), with mean age of 69 years (range, 31-91 years), were implanted with magnetic sphincter augmentation. Follow-up ranged from 353 to 738 days. Previous treatment consisted of peripheral nerve evaluation test in 10 patients (56%), 2 patients (11%) with previous permanent sacral nerve stimulation, and 1 patient (6%) with previous implantation of an artificial bowel sphincter. Implantation was successful in 17 (94%) of 18 patients. Five patients (29%) had postoperative pain, and 5 patients (29%) had temporary swelling and erythema in both gluteal regions after the implantation. No devices were explanted during the follow-up. Cleveland Clinic Incontinence Score decreased from a mean of 17.5 (range, 14.0-20.0) to 7.3 (range, 0-12.0), and Fecal Incontinence Quality of Life scores improved in all of the domains. Bowel diary results showed that 76% of the patients with implants experienced a ≥50% reduction in the number of fecal incontinence episodes per week. Manometry at 6 months after implantation showed increased mean resting and squeeze pressures.

LIMITATIONS

This study does not allow for comparison between surgical treatments and involves a limited number of patients.

CONCLUSIONS

Magnetic sphincter augmentation shows consistent results for the treatment of severe fecal incontinence in this patient group. The surgical procedure is straightforward as compared with other implantable devices. The safety profile is acceptable. Magnetic sphincter augmentation is a promising new treatment with the potential to become a first-line surgical therapy for patients with severe fecal incontinence.