NCT01920607

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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)

Conditions

• Fecal Incontinence
• Anal Incontinence

Interventions

Type	Name	Description
DEVICE	magnetic anal sphincter
DEVICE	sacral nerve stimulation

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2017-08-01
• First posted: 2013-08-12
• Last updated: 2017-06-26

Locations

1 site across 1 country: France