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FIT Study

The purpose of this research study is to compare three different FDA approved treatments for fecal incontinence (also known as accidental bowel leakage) in men and women in terms of how well the treatments work, how safe the treatments are, and now much the treatments cost. The treatments are biofeedback therapy, sacral nerve electrical stimulation (SNS), or dextranomer injections.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

(Visit 1) Screening, (Visit 2) Baseline, (Visit 3) Assigned to a treatment group with additional visits: [SNS up to 2 visits, INJ up to 2 visits, and BIO up to 5 visits], (Follow Up Visits) 4 total - at 3 months, 6 months, 1 year, 2 years. Also, Up to 12 phone calls over the 2 year study period.

Incentives

Compensation will depend on which group you are assigned to., You will be compensated for research-related activities and provided mileage reimbursements. You may also be reimbursed for over-the-counter medication purchases related the study, and if assigned to the SNS group, up to $3,074 for associated insurance deductibles or copayments.

In-person visits : 9-12
Phone or online visits : 12
Total length of participation : 2 Years

Looking for Specific Volunteers

Able to participate:

  • You experience accidental bowel leakage on average twice a week (or about 8 times a month)
  • You are able to walk on a level surface on your own or with the assistance or a cane or walker
  • You are not pregnant or planning to become pregnant in the next two years

Not eligible if:

  • Are typically able to reach a toilet before leaking stool when you have a feeling of urgency to have a bowel movement
  • Have regular watery diarrhea that is not managed by diet or drugs
  • Have been diagnosed with IBD (Crohn's disease or Ulcerative Colitis)
  • Have previously tried SNS or Dextranomer injections
  • Have a neurodegenerative condition such as dementia, spinal cord injury, spina bifida, Parkinson's disease, multiple sclerosis, or severe diabetic neuropathy

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

William Whitehead
Medicine-Gastroenterology

Study Type

Clinical or Medical

Study Topics

Stomach, Digestion and Gut Health
Women's Health
Men's Health

IRB Number

17-0525

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