At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with chronic fecal incontinence lasting >6 months (>12 months post-vaginal childbirth), defined as >2 incontinent episodes per week on average (more than staining) during baseline diary period
- ✓Failed or are not suitable candidates for conservative treatments
- ✓Age 18 years or older
- ✓Willing and able to complete bowel diaries and questionnaires throughout the study
- ✕Congenital anorectal malformations
- ✕Active rectal prolapse
- ✕Prior rectal surgery (rectopexy, resection) or sphincteroplasty within 12 months (24 months for cancer)
- ✕Neurological diseases including clinically significant peripheral neuropathy or complete spinal cord injury
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
In Brief
A clinical study evaluating InterStim Sacral Nerve Stimulation Therapy for Fecal Incontinence. Completed, enrolled 285 participants across 13 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Open label study. All subjects that qualify for the study will be implanted.