Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence

NCT01920607 | Suspended

• 1 other identifier: RC13_0209
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fecal Incontinence; Anal Incontinence

Keywords

Fecal Incontinence.; Anal Incontinence.; Functional Bowel Disorders.; SNS.; Artificial Sphincters.; Magnetic Anal Sphincter.

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (5)

• Overall cost for the health care system

  12 months

• Respective complications of the two therapeutic approaches

  12 months

• Functional results at 6 and 12 months, compared with baseline

  Baseline, 6 & 12 months

• Quality of life and overall satisfaction

  Baselnie, 6 & 12 months

• Anorectal manometry data

  Baseline & 6 months

Study Arms (2)

NMS

ACTIVE COMPARATOR

Implantation under general of local anesthesia of sacral nerve stimulation system (Interstim Therapy)

Device: sacral nerve stimulation

SAM

EXPERIMENTAL

Implantation under general anesthesia of magnetic anal sphincter (Fenix)

Device: magnetic anal sphincter

Interventions

magnetic anal sphincter DEVICE

Also known as: Fenix

SAM

sacral nerve stimulation DEVICE

Also known as: Interstim

NMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 4000, France

Location

Related Publications (1)

• Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012 Jun;14(6):e323-9. doi: 10.1111/j.1463-1318.2012.02995.x.

  PMID: 22339789 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

FR (1)