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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:

Stefanie Twist
sjeremia@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 fecal incontinence 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: - You cannot have dementia, which will be assessed during the screening visit. - If you have urgency to have a bowel movement, but are able to reach a toilet in time without leaking stool, you should not be in this research study. - If you have watery diarrhea that is not managed by diet or drugs, you should not participate in this research study. - If you are pregnant or planning to become pregnant in the next two years, you should not participate in this research study. - You cannot have a lot of damage to your anal sphincter, as identified on anorectal ultrasound or pelvic floor MRI. This procedure is scheduled as part of the research study to see if there is any damage to your sphincter. - You cannot have a spinal cord injury, spina bifida, or congenital malformation of the anorectum. - You cannot have complete rectal prolapse (where part of your intestine comes out when you have a bowel movement or is protruding out all the time) or grade III / grade IV hemorrhoids (where hemorrhoids come out when you have a bowel movement or are protruding all the time). - You cannot have previous anorectal surgery, such as having a hemorrhoid stapled or stapled transanal rectal resection (STARR procedure). If you had artificial sphincter surgery or have had hemorrhoids surgically removed more than six months ago, you could still be able to participate. - You cannot have a diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) - If you have previously failed a trial placement of sacral nerve stimulation or dextranomer injections, you should not participate in this research study. - You cannot participate if you have a medical disorder likely to require follow-up with MRI of the body (not the head or neck). - If you are allergic to hyaluronic acid based products, you should not participate in this study. If you have any active anorectal conditions, such as abscessess, fissures, sepsis, significant anal / rectal bleeding, proctitis, colovaginal and rectovaginal fistulas, anorectal tumors, or other infections near the anus and rectum. - If you have Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by EMG, or a neurodegenerative disorder, you should not participate in this research study. -

Number of Visits

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

    (Visit 1) Screening, (Visit 2) Baseline, (Visit 3) Randomization: [SNS can have up to 2 visits, INJ can have up to 2 visits, and BIO can have up to 5 visits], 3 Month Follow-Up (Visit 4), 6 Month Follow Up (Visit 5), 12 Month Follow Up (Visit 6), 24 Month Follow Up (Visit 7)

    » 12 Remote visit(s)

    Up to 12 phone calls will be made over the 2 year study period. Up to 3 phone calls between screening and baseline visits, up to 3 phone calls between baseline and randomization visit, and phone calls before in-person visits as reminder phone calls.

Participation Period

2 Years

Compensation

Compensation varies depending on which arm you are assigned. Participants will be compensated for any research related diagnostic procedures, diary completion, mileage reimursements, reimbursed for over-the-counter medication purchases related the the study, and if assigned to the SNS arm, will be reimbursed up to $3,074 for 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.