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Fecal Incontinence Treatment (FIT) Study
NCT03811821 · View on ClinicalTrials.gov ↗
Study Summary
Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a 2-week daily stool diary. All participants will initially be enrolled into a 4-week trial of Enhanced Medical Management (EMM; education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency). Those who demonstrate at least a 75% reduction in FI frequency will not be randomized to one of the two treatment groups but will be followed-up for two years. Those not showing a 75% reduction in FI frequency will be randomized to BIO or INJ and will be evaluated three months later with respect to efficacy for reducing the frequency of fecal incontinence, safety of the interventions, and cost of providing care. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will be followed-up for a further 21 months, for a total of 24 months from the time of treatment initiation. To assess the long-term response to treatment, those who improve less than 75% in FI episodes will be offered an additional treatment with either the treatment to which they were not randomized or sacral nerve stimulation (SNS). Anorectal manometry and Magnetic Evoked Potentials will be used to subtype the physiological basis for FI. Quality of life and psychological factors will be used to assess outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Biofeedback
- DEVICE Injection
Study Locations (6)
Minnesota
- Mayo Clinic — Rochester
- Colon and Rectal Surgery Associates, Ltd. — Saint Paul
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Augusta University Medical College of Georgia — Augusta
Michigan
- University of Michigan — Ann Arbor
North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03811821
The ClinicalTrials.gov registry entry for NCT03811821 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Fecal Incontinence appearing as the primary indexed condition, and to 2 interventions — of which Biofeedback is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03811821 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Minnesota, Alabama, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03811821 about?
NCT03811821 is a clinical study titled "Fecal Incontinence Treatment (FIT) Study". Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a ...
What is the current status of trial NCT03811821?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 275 participants. The study started on 2019-02-01. Estimated completion is 2026-02-28.
What conditions does trial NCT03811821 study?
This clinical trial studies the following conditions: Fecal Incontinence, Bowel Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03811821?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Injection (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03811821?
This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03811821 being conducted?
This trial has 6 study locations across Alabama, Georgia, Michigan, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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