Fecal Incontinence Treatment (FIT) Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

May 16, 2024

Study Completion Date

December 31, 2025

Conditions
Fecal IncontinenceBowel 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.

Trial Locations (6)

27599

The University of North Carolina at Chapel Hill, Chapel Hill

30912

Augusta University Medical College of Georgia, Augusta

35801

University of Alabama at Birmingham, Birmingham

48109

University of Michigan, Ann Arbor

55114

Colon and Rectal Surgery Associates, Ltd., Saint Paul

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

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

NIH

collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Colon and Rectal Surgery Associates, Ltd.

OTHER

collaborator

Augusta University

OTHER

collaborator

RTI International

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

University of Michigan

OTHER

lead

Mayo Clinic

OTHER

NCT03811821 - Fecal Incontinence Treatment (FIT) Study | Biotech Hunter | Biotech Hunter