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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Nantes University Hospital
Nantes, France
Average number of fecal incontinence episodes
Average number of fecal incontinence episodes per week over a period of 3 weeks, 6 months after the implantation of a magnetic anal sphincter (FenixTM magnetic anal sphincter group) or of the Spinelli electrode during the PNE test (sacral nerve stimulation group), on the basis of a standardised stool diary
Time frame: 6 months
Overall cost for the health care system
Overall cost for the health care system including implantation and follow-up - Duration and cost of hospital admissions,- Cost of covering any complications arising
Time frame: 12 months
Respective complications of the two therapeutic approaches
Number and nature of the complications over 12 months, according to the Clavien-Dindo classification
Time frame: 12 months
Functional results at 6 and 12 months, compared with baseline
Stool record chart, faecal incontinence score (Wexner), recourse to antidiarrhoeal treatment, the taking of analgesics, constipation score (ODS), recourse to a treatment for constipation
Time frame: Baseline, 6 & 12 months
Quality of life and overall satisfaction
Quality of life and overall satisfaction of the patient at 6 and 12 months, compared with baseline:Quality of life score specific to faecal incontinence (FIQL), General quality of life scores (SF 36 and EQ-5D)
Time frame: Baselnie, 6 & 12 months
Anorectal manometry data
Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume.
Time frame: Baseline & 6 months
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