NCT00200057

Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating. If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	InterStim Sacral Nerve Stimulation Therapy	Open label study. All subjects that qualify for the study will be implanted.

Timeline

• Start date: 2002-01-01
• Primary completion: 2007-08-01
• Completion: 2011-09-01
• First posted: 2005-09-20
• Last updated: 2013-01-24
• Results posted: 2011-08-30

Locations

13 sites across 2 countries: United States, Canada