Fecal Incontinence Treatment (FIT) Study

Completed · Not applicable

Conditions studied: Fecal Incontinence, Bowel Incontinence

In brief

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.

Key facts

Study ID

NCT03811821

Run by

Mayo Clinic

People needed

275

Starts

2019-02-01

Expected to finish

2026-01-27

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Physician diagnosis of FI (R15) for the past 6 months or longer.
• Able to ambulate independently on level surfaces. Patient may use assistive devices other than parallel bars.
• Average >2 staining, solid or liquid FI episodes per week by self-report and during the two-week baseline
• Meets criteria for dextranomer treatment except an internal anal sphincter defect of 180 degrees or less is acceptable.
• Less than 75% reduction in the number of FI episodes after 4 weeks of conservative treatment.
• Age >=18 years

You may not qualify if…

• Dementia, assessed using the Six-Item Screener to Identify Cognitive Impairment.
• Obstetrical injuries including third and fourth degree tears in the anal sphincter within the past 6 months.
• Pregnant or planning pregnancy in next 2 years
• Internal anal sphincter separation >180 degrees on ultrasound or magnetic resonance imaging
• Spinal cord injury or spina bifida
• Congenital malformation of anus or rectum
• Complete rectal prolapse or grade III/IV hemorrhoids
• History of ileoanal pouch; history of anal sphincteroplasty, rectopexy, or rectocele repair within the past 6 months; or history of pelvic surgery with synthetic graft and suspected graft erosion into the anus, rectum, or skin or if the graft ends less than approximately 1" above the upper limit of the anal canal.
• Established diagnosis of inflammatory bowel disease
• Intestinal stoma present
• History of pelvic radiation within previous 12 months or presence of active radiation proctitis.
• Patients who cannot expel the rectal balloon during the balloon expulsion test and who have constipation most of the time.
• Anatomic limitations to placement of dextranomer injections.
• Presence of existing implant in the anal or rectal region
• Allergy to hyaluronic acid-based products
• Active anal or rectal conditions in the last 6 months including abscess, fissures, sepsis, significant bleeding, proctitis, colovaginal and rectovaginal fistulas, anal or rectal tumors, or other infections.
• The patient's physician believes it is unsafe for the patient to temporarily stop anticoagulants for any test procedures and treatments associated with the study.
• Patients who have 4 or more days with 4 or more bowel movements classed as a 6 or 7 on the Bristol Stool Scale per day in either (any) week bowel movements classed as a 6 or 7 during the Baseline will be excluded.
• Patients with Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by electromyography (EMG), and neurodegenerative disorder.
• Patients currently receiving immunotherapy or chemotherapy.
• Significant anal pain in the last 6 months.
• Unwillingness of participant to stop using over-the-counter medications, herbal supplements, or prescribed medications for the purpose of modifying stool consistency, that are not included in the approved medications list (loperamide, laxatives, fiber supplements, and Questran are approved medications), for the duration of the research study.
• Medical history will be documented to test for predictors of response.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Augusta University Medical College of Georgia — Augusta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Colon and Rectal Surgery Associates, Ltd. — Saint Paul, Minnesota, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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