Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200057
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-12
Brief Title:
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
Medtronic InterStim Sacral Nerve Stimulation Therapy for Bowel Control Fecal Incontinence Study
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
If a patient is suffering with symptoms of chronic FI despite trying oral medications biofeedback andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None