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.
(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.
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.
Clinical or Medical
Stomach, Digestion and Gut Health