Fecal Incontinence Treatment (FIT) Study

NCT03811821 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: 18-0046511U01DK115575-01
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 6

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 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

Fecal Incontinence; Bowel Incontinence

Keywords

Accidental Bowel Leakage; Fecal Incontinence; Biofeedback; Sacral Nerve Stimulation; Injectable Bulking Agents; Enhanced Medical Management

Outcome Measures

Primary Outcomes (3)

• Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline

  FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.

  3-month follow-up

• Proportion of Participants With Specified Adverse Events at Month 3 Follow-Up

  Adverse events of pelvic pain of grade II or higher based on Common Terminology Criteria for AE (CTCAE) criteria, treatment site infection, or serious adverse events (SAEs) requiring hospitalization.

  3-month follow-up

• Treatment Costs at Month 3 Follow-Up

  Costs will be measured in three categories: (a) Procedure costs based on number of treatment visits and Medicare reimbursement rates. (b) Patient direct costs for travel and parking for visits. (c) Indirect costs of time losses resulting from attending visits. These costs will be combined to establish overall societal costs.

  3-month follow-up

Secondary Outcomes (7)

• Change in the Severity of FI as Assessed Using the Fecal Incontinence Severity Scale

  up to 24 months

• Change in Quality of Life as Assessed Using the Fecal Incontinence Quality of Life Scale

  up to 24 months

• Change in Psychological Distress as Assessed Using the 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  up to 24 months

• Change in Psychological Distress as Assessed Using the 8-item PROMIS Depression Scale

  up to 24 months

• Change in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale

  up to 24 months

Study Arms (2)

Biofeedback (BIO)

ACTIVE COMPARATOR

Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.

Behavioral: Biofeedback

Injection (INJ)

ACTIVE COMPARATOR

Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.

Device: Injection

Interventions

Biofeedback BEHAVIORAL

The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.

Biofeedback (BIO)

Injection DEVICE

The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.

Injection (INJ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of North Carolina, Chapel Hill: collaborator
• RTI International: collaborator
• University of Alabama at Birmingham: collaborator
• University of Michigan: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Colon and Rectal Surgery Associates, Ltd.: collaborator
• Augusta University: collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35801, United States

Location

Augusta University Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Colon and Rectal Surgery Associates, Ltd.

Saint Paul, Minnesota, 55114, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Butt MF, Rao SSC, Meyer I, Chey WD, Whitehead WE, Richter HE, Menees SB, Busby-Whitehead J, Lamichhane R, Chen J, Hamilton FA, Bharucha AE. Cluster Analysis of Fecal Incontinence Symptoms: Associations With Anorectal Physiology and Quality of Life. Clin Gastroenterol Hepatol. 2025 Nov 24:S1542-3565(25)00999-1. doi: 10.1016/j.cgh.2025.11.015. Online ahead of print.

  PMID: 41297739 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Biofeedback, Psychology; Injections

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Drug Administration Routes; Drug Therapy

Results Point of Contact

• Title: Adil Bharucha, M.B.B.S., M.D.
• Organization: Mayo Clinic

bharucha.adil@mayo.edu

507-266-6931

Study Officials

• Adil Bharucha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants who do not demonstrate at least a 75% reduction in FI following a 4-week trial of EMM will be randomized to one of two treatments (INJ or BIO) and assessed after three months. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will then be followed-up for two years. To assess the long-term response to treatment, those who demonstrate an improvement of less than 75% in FI episodes will be offered an additional treatment with either the treatment to which they were not initially randomized or SNS. An anticipated 285 participants will be enrolled in the EMM to ensure a sample size of 97 in each of the two treatments arms.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: February 1, 2019
• Primary Completion: May 16, 2024
• Study Completion: February 28, 2026
• Last Updated: February 20, 2026
• Results First Posted: May 6, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Following approval from an appropriate review board as described above and execution of a data use/sharing agreement with UNC-Chapel Hill.

Locations

US (6)