Magnetic anal sphincter augmentation effective for fecal incontinence

Last Updated: 2017-10-09

By Reuters Staff

NEW YORK (Reuters Health) - Magnetic anal sphincter augmentation (MSA) reduces leakage and improves quality of life (QOL) in patients with severe fecal incontinence, especially those with no previous surgical treatment for incontinence, researchers report.

The MSA device, a circular titanium implant placed around the anorectal junction, is designed to reinforce the anal sphincter mechanism. It widens while straining during defecation and magnetically self-retracts afterwards.

Dr. Paul Antoine Lehur from University Hospital of Nantes, in France, and colleagues analyzed functional results, QOL, and satisfaction among 45 patients with severe fecal incontinence who underwent MSA implantation from December 2008 to January 2016. Median follow-up was 36 months.

The findings were published online September 11 in Annals of Surgery.

The mean total Cleveland Clinic Incontinence Score (CCIS) improved significantly from baseline to last follow-up (from 14.83 to 8.98). Mean Fecal-Incontinence Quality of Life scores also improved significantly (from 2.00 to 2.80).

After implantation, patients experienced significant reductions in overall leakage and in major, solid, and liquid leaks - as well as total number of urgent episodes, according to bowel diaries kept for three weeks.

About 62% of patients reported satisfaction with the treatment. Satisfied patients were more likely than unsatisfied patients to have improvements in continence and QOL after the procedure.

CCIS improvement of at least 5.5 points, achieved by 22 patients, predicted satisfaction with an accuracy of 96.9%.

In multivariate analysis, previous operative treatment for fecal incontinence was the only independent predictor of a failed outcome after MSA implantation.

"The significance of MSA in the algorithm of the operative therapy in patients with fecal incontinence (FI) is still under discussion, and cannot be answered by the reported data," the researchers conclude. "Nonetheless, our results show that MSA is a promising treatment tool in refractory patients, but imply that those who underwent surgery for FI before MSA benefit less from implantation. This information might help guiding patients' expectations, which might be overwhelming in a refractory and quality of life-limiting situation."

"Clearly more will be known on MSA effectiveness and relevance in FI treatment algorithm," they add, "with the results of 2 prospective, randomized, controlled trials - MOS STIC and SaFaRI - comparing MSA and the current first-line surgical treatment, sacral nerve stimulation (SNS)."

The FENIX Continence Restoration System used in this study received U.S. FDA approval, in January 2016, as a Humanitarian Device Exemption for use in patients with fecal incontinence that does not respond to conservative care or other surgical therapies.

Dr. Lehur has a consulting agreement with Torax Medical Inc., manufacturer of the FENIX MSA device.

Dr. Lehur did not respond to a request for comment.

SOURCE: http://bit.ly/2vYkfDe

Ann Surg 2017.