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

June 23, 2017 updated by: Nantes University Hospital
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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 4000
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NMS
Implantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy)
Device: sacral nerve stimulation
Other Names:
  • Interstim
Experimental: SAM
Implantation under general anesthesia of magnetic anal sphincter (Fenix)
Device: magnetic anal sphincter
Other Names:
  • Fenix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
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
Baseline, 6 & 12 months
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)
Baselnie, 6 & 12 months
Anorectal manometry data
Time Frame: Baseline & 6 months
Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume.
Baseline & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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