Study Title: Comparative Effectiveness of Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents for Treatment of Fecal Incontinence: The Fecal Incontinence Treatment (FIT) Study
The FIT Study is a multi-site, National Institutes of Health (NIH) funded clinical research study comparing the efficacy, safety, and cost of three FDA-approved treatments in patients with moderate to severe fecal incontinence. The three treatments are biofeedback therapy, sacral nerve stimulation, and Solesta injectable bulking agents.
This study has four stages:
- Baseline: We will collect health information to assess inclusion/exclusion criteria and perform diagnostic tests (anorectal ultrasound or pelvic floor MRI, anorectal manometry). Study participants will not have to pay for these diagnostic tests.
- Enhanced medical management: All participants will be recommended behavior changes and medications to manage constipation or diarrhea to see if incontinence can be managed conservatively without the need of further treatment. All participants will be assessed after a four week period to determine their response to the enhanced medical management. Participants will be reimbursed for medications purchased specifically for the research study.
- Randomization: If participants do not improve with enhanced medical management, they will be randomly assigned to receive biofeedback by a physical therapist or injection of gel called Solesta into the anal area in the hopes of improving their fecal incontinence. Biofeedback and Solesta will be covered by the study. If they significantly improve with the enhanced medical management, they will continue to follow the enhanced medical management program and not be randomized to biofeedback or Solesta.
Participants who originally respond to the enhanced medical management, but who are then determined at the 3-month follow-up to no longer be responding may then be randomized to one of the randomized treatments; otherwise, they will remain on only the enhanced medical management treatment for two years. Randomized participants who are determined to have failed their randomized treatment at the 3-month follow-up visit are given an opportunity to choose the other randomized treatment.
Follow-Up Visits: Participants will be assessed either in clinic or by phone at 3, 6, 12, 18 and 24-months. Participants are compensated for time and travel to the clinic for each visit.
For more information about this study please visit the Clinical Trials Website.