Fecal Incontinence Treatment (FIT) 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

• Fecal Incontinence
• Bowel Incontinence

Interventions

BEHAVIORAL

Biofeedback

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

DEVICE

Injection

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Colon and Rectal Surgery Associates, Ltd.

  collaborator OTHER

• Augusta University

  collaborator OTHER

• RTI International

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Mayo Clinic

  lead OTHER

Principal Investigators

• Adil Bharucha, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2024-05-16

Completion

2026-01-27

FDA Device

Yes

Countries

• United States

Study Locations