Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence (MOS STIC)
|Fecal Incontinence Anal Incontinence||Device: magnetic anal sphincter Device: sacral nerve stimulation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence|
- Average number of fecal incontinence episodes [ Time Frame: 6 months ]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
- Overall cost for the health care system [ Time Frame: 12 months ]Overall cost for the health care system including implantation and follow-up - Duration and cost of hospital admissions,- Cost of covering any complications arising
- Respective complications of the two therapeutic approaches [ Time Frame: 12 months ]Number and nature of the complications over 12 months, according to the Clavien-Dindo classification
- Functional results at 6 and 12 months, compared with baseline [ Time Frame: Baseline, 6 & 12 months ]Stool record chart, faecal incontinence score (Wexner), recourse to antidiarrhoeal treatment, the taking of analgesics, constipation score (ODS), recourse to a treatment for constipation
- Quality of life and overall satisfaction [ Time Frame: Baselnie, 6 & 12 months ]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)
- Anorectal manometry data [ Time Frame: Baseline & 6 months ]Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||August 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: NMS
Implantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy)
Device: sacral nerve stimulation
Other Name: Interstim
Implantation under general anesthesia of magnetic anal sphincter (Fenix)
Device: magnetic anal sphincter
Other Name: Fenix
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920607
|Nantes University Hospital|
|Nantes, France, 4000|