Trial record 18 of 25 for:    Neuroleptic Malignant Syndrome

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01920607
First received: August 8, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Fecal Incontinence.
Anal Incontinence.
Device: magnetic anal sphincter
Device: sacral nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Average number of fecal incontinence episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Overall cost for the health care system [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Sphincter pressure at rest, voluntary contractions, rectal maximum tolerable volume.


Estimated Enrollment: 156
Study Start Date: November 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NMS
Implantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy)
Device: sacral nerve stimulation
Other Name: Interstim
Experimental: SAM
Implantation under general anesthesia of magnetic anal sphincter (Fenix)
Device: magnetic anal sphincter
Other Name: Fenix

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920607

Contacts
Contact: Paul-Antoine LEHUR, MD PHD +33 2 40 08 30 22 paulantoine.lehur@chu-nantes.fr
Contact: Cécile DERT +33 2 53 48 28 52 cecile.dert@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 4000
Contact: Paul-Antoine Lehur, MD PHD    +33 2 40 08 30 22    paulantoine.lehur@chu-nantes.fr   
Contact: Vincent Wyart    +33 2 40 08 49 78    vincent.wyart@chu-nantes.fr   
Principal Investigator: Paul-Antoine LEHUR, MD PHD         
Sponsors and Collaborators
Nantes University Hospital
  More Information

Publications:
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01920607     History of Changes
Other Study ID Numbers: RC13_0209
Study First Received: August 8, 2013
Last Updated: December 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Fecal Incontinence.
Anal Incontinence.
Functional Bowel Disorders.
SNS.
Artificial Sphincters.
Magnetic Anal Sphincter.

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014