Award
National Institute of Diabetes and Digestive and Kidney Diseases 7U01DK115575-05
Fecal Incontinence Treatment Study (FIT Study)
Recipient
Mayo Clinic Rochester, Rochester, MN, United States
Award Amount
$1,377,218.00
Ceiling
$1,377,218.00
Awarded
August 15, 2023
Identifier
7U01DK115575-05
Award for a study comparing three treatments for moderate to severe fecal incontinence to determine efficacy, safety, and cost-effectiveness over two years.
Description
This is an initial application for a U01 comparing three previously validated treatments for moderate to severe fecal incontinence (biofeedback, sacral nerve stimulation, and injection with the inert bulking agent dextranomer) to each other in the same cohort of patients. Patients will be randomized to these treatments, compared on the basis of efficacy, safety, and cost, and followed for two years. Physiological mechanisms of anal sphincter function, anorectal pressures, and sacral nerve conduction times; psychosocial predictors; and clinical outcomes will be measured to identify the best predictors of a positive response.