Fecal Incontinence Clinical Trial
Official title:
Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence
The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence
Severe anal incontinence, defined as the uncontrolled passing of stool at least once a week,
is a problem that has a serious impact on the quality of life. In the event of failure of
conservative treatments, surgery can help improve continence problems in a significant
number of cases.
Sacral nerve stimulation is currently the standard surgical treatment for severe anal
incontinence when sphincter repair (sphincteroplasty) is not recommended.
A new method of treatment based on sphincter reinforcement through the implanting of a band
of magnetic beads*, has proved to be reliable and efficient on a small series of cases,
particularly after the failure of sacral nerve stimulation.
The aim of our trial, which compares the "magnetic anal sphincter* and sacral nerve
stimulation" in a homogeneous population of patients affected by severe anal incontinence is
to define the position of this new approach in the treatment algorithm of this functional
disorder, determining its clinical and medical/economic advantages compared to those of the
current standard treatment.
* FenixTM (Torax Medical)
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