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NCT03811821 · ClinicalTrials.gov registry record · NA
Fecal Incontinence Treatment (FIT) Study
A NA study of Fecal Incontinence and Bowel Incontinence, sponsored by Mayo Clinic.
- Active
- Registry status
- NA
- Development phase
- 275
- Enrollment target
- 6
- Study locations
NCT03811821: Active NA study of Fecal Incontinence and Bowel Incontinence, sponsored by Mayo Clinic.
NCT03811821 is a NA study of Fecal Incontinence and Bowel Incontinence that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 275 participants, below the 323-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (15% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03811821, a NA study of Fecal Incontinence and Bowel Incontinence, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 275 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.
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 |
What the registry record for NCT03811821 still lists
NCT03811821 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (15% lower).
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.
NCT03811821 lists 6 locations in 5 states (Minnesota, Alabama, Georgia).
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.
What interventions are being tested in trial NCT03811821?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Injection (DEVICE).
Who is sponsoring clinical trial NCT03811821?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03811821's enrollment target sits among peer trials
275 5th of 22 higher than 18 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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