IRB Number:

912-02

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Surgical treatments for fecal incontinence have included sphincteroplasty, muscle interpositions and finally colostomy. Results have been dismal to date. This has led to the concept of InterStim sacral nerve stimulation which may be beneficial in treating fecal incontinence through modulation of the S3 sacral nerve. This study is a multi-center trial to evaluate the device in patients with documented fecal incontinence where conventional treatment options have failed.

Who is Eligible to Participate in the Study?

Inclusions criteria include: age 18 and over, must be able to sign consent forms, fecal incontinence as documented on Bowel Diary to be provided upon enrollment in the study.

Evaluation testing should include intact anal sphincter as documented on transrectal ultrasound or MRI, anal function tests, EMG (pudendal nerve latency test), recent endoscopy to exclude other reasons for incontinence. The patients must have no other reasons for incontinence ( i.e. malabsorption, diarrhea, spinal cord injury) and have failed conventional treatment options.

Minimum Age:

18

Additional Requirements / Information

The patients are evaluated during their first visit and the appropriate testing done. Once they fulfill the eligibility criteria, they will have a Bowel Diary to complete for 2 weeks.Completed diaries will be examined by the study sponsor and once the patient is deemed eligible, they will be scheduled for the initial electrode implantation. An external stimulator will be used for 2 weeks with the patient completing a Bowel Diary again. The diary will be examined by the study sponsor prior to permanent implantation. After final implantation, patients will be seen at the 1,3,6 and 12 month follow-up.

Who can I Contact for Additional Information on this Trial?

Principal investigator: Heidi Chua, M.D., Department of Colorectal Surgery, Mayo Clinic in Jacksonville
Co-investigator: Paul Pettit, M.D., Department of Gynecology, Mayo Clinic in Jacksonville
Clinical Studies Coordinator: Diane Cooper
Contact number: (904) 953-2000

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 11/19/2004