Status:
ACTIVE_NOT_RECRUITING
Fecal Incontinence Treatment (FIT) Study
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Conditions:
Fecal Incontinence
Bowel Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 bulk...
Detailed Description
This is an unmasked, multisite, randomized, parallel group study comparing the effectiveness of two treatments \[BIO and INJ\] for moderate to severe FI: 1. Baseline: Participants will keep a daily s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT03811821
Start Date
February 1 2019
End Date
December 31 2025
Last Update
May 6 2025
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35801
2
Augusta University Medical College of Georgia
Augusta, Georgia, United States, 30912
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Mayo Clinic
Rochester, Minnesota, United States, 55905