Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence (MOS STIC)

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence., Anal Incontinence., Functional Bowel Disorders., SNS., Artificial Sphincters., Magnetic Anal Sphincter. Read More

Inclusion Criteria:

• Adult patient (male or female) of 18 to 75 years of age
• Affected by severe anal incontinence (SAI)*.
• Documented failure of conservative treatment (reeducation and medical treatment)
• With functional anal sphincter**
• Agrees to take part in the study and has signed the informed consent form
• Agrees to undergo post-operative surveillance for a period of one (1) year

• Covered by National Insurance

  • Defined as follows: at least one involuntary passing of stool per week measured by collecting data on incontinence accidents on a 3-week stool record chart, with the continence problem developing over more than 6 months. **Defined as follows: external sphincter intact (without injury or after sphincter repair) or external sphincter altered, with an injury of a size that does not justify sphincter repair.

Internal sphincter injuries not taken into account (by professional consensus).

Exclusion Criteria:

• Anorectal or pelvic malformations
• Local conditions incompatible with the proposed sizes of the MAS (extreme obesity, thickness of the tissue in the anorectal area)
• Sequelae of rectal resections - presence of cancer of the rectum or anus
• Rectal prolapse and/or major pelvic floor disorders
• Major chronic disorder of the intestinal motility, irritable bowel syndrome, repeated faecalomas, megarectum
• Extensive sphincter degeneration
• Consequences of radiation-induced rectitis and chronic inflammatory diseases of the bowel (Crohn's disease)
• Neurological disorders or systemic diseases (multiple sclerosis, scleroderma, paraplegia)
• Festering sores of the perineal and/or anorectal regions
• Known or suspected risks of allergy to titanium
• Active pelvic infection

• Contraindications to SNS:

  • Cardiac stimulator or defibrillator implant
  • Malformation of the sacrum
  • Patient exposed to Magnetic Resonance Imaging
  • Skin diseases exposing the patient to the risk of infection (at the investigator's discretion)
  • Patient scheduled for diathermy or ablation by radiofrequency
• Pregnant women
• Adults under guardianship
• Patients involved in a mobility project in the year following the operation
• Patient already subjected to one or other of the therapeutic approaches (MAS or SNS) Please note: coagulation problems (including anti-aggregant or anti-coagulant treatments) are not a contraindication if these problems can be corrected during the perioperative period.