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FIT Study

University of North Carolina at Chapel Hill


Description

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.


Keywords:

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


Category:

Medical Treatment Outcomes

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Men and women over the age of 18 years old who experience fecal incontinence (FI), also known as accidental bowel leakage (ABL), at least twice a week.


Investigator

William Whitehead
Professor
Medicine-Gastroenterology

For questions, contact:

Kimberly Psaltis
kimberly_psaltis@med.unc.edu
(919) 843-6961


Recruitment Period End

September 1, 2023

Location

Primary Location
UNC Center for Functional GI and Motility Disorders
Old Dental Building, 150 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
UNC Urogynecology and Reconstructive Pelvic Surgery, Suite 315
4325 Lake Boone Trail, Raleigh, NC 27607, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) - 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.

Not eligible if: 1) Are typically able to reach a toilet before leaking stool when you have a feeling of urgency to have a bowel movement. 2) Have regular watery diarrhea that is not managed by diet or drugs. 3) Have been diagnosed with IBD (Crohn's disease or Ulcerative Colitis) 4) Are pregnant or planning to become pregnant in the next 2 years 5) Experience that part of your intestine or a hemorrhoid comes out of your body when you have a bowel movement or is out all the time 6) Have previously tried SNS or Dextranomer injections 7) Need to have regular MRIs 8) Have had previous anorectal surgery (like having a hemorrhoid staples or a STARR procedure) 9) Have any damage, infection, or malformation of the anus or rectum. 10) Dementia, spinal cord injury, spina bifida, Parkinson's disease, multiple sclerosis, severe diabetic neuropathy, or another neurodegenerative condition.

Number of Visits

    » Between 9 to 12 in-person visits (depending on which group you are assigned to) In person visit(s)

    (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.

    » 12 Remote visit(s)

    Up to 12 phone calls over the 2 year study period.

Participation Period

2 Years

Compensation

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.

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.