Home Versus Office Biofeedback Therapy for Fecal Incontinence

NCT03216291 | Completed

• 1 other identifier: HomeVOfficeFI
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with Fecal Incontinence. It is not easily available to the vast majority of patients in the community with this problem. It is therefore imperative that a more pragmatic therapeutic approach that can be administered easily in the community ought to be developed. However, whether a treatment program that is based on home-training can be just as useful as office-based training has not been evaluated. The purpose of this study is to assess whether having patients train their pelvic floor muscles at home is as effective as in-office biofeedback training.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of episodes of fecal incontinence

  Assess the change in the No of FI episodes between baseline week and end of study week and compare between the two treatment groups. Responder is defined as a patient with greater than 50% reduction in FI episodes after treatment when compared to baseline. Responder rates will compared between the two treatment groups.

  six weeks

Secondary Outcomes (4)

• Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires

  six weeks

• Anal sphincter pressure and rectal sensation

  six weeks

• FI severity, quality of life and bowel symptoms

  Six weeks

• Treatment compliance with home biofeedback

  Six weeks

Study Arms (2)

Home Biofeedback

ACTIVE COMPARATOR

Patients will be given home biofeedback device (InTone) to take home and practice biofeedback exercises at least twice a day for six weeks of therapy. Intervention: Home device biofeedback training.

Device: Home Biofeedback therapy

Office biofeedback

ACTIVE COMPARATOR

Patients with fecal incontinence will receive traditional office biofeedback, once weekly, over six weeks. Intervention: Regular office biofeedback training with assistance of biofeedback person..

Behavioral: biofeedback therapy

Interventions

biofeedback therapy BEHAVIORAL

Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems. Complete training sessions once a week for 6 weeks in the office.

Also known as: Training

Office biofeedback

Home Biofeedback therapy DEVICE

Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems, but instead of an office therapy, the subject will use a biofeedback device to gain strength in their anorectal muscles. This device will be taught how to use in the first session and then the subject will take it home to complete at least 1 session a day for 6 weeks.

Home Biofeedback

Eligibility Criteria

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

You may qualify if:

• recurrent episodes of fecal incontinence for six months
• no mucosal disease
• on a two week stool diary patient will report at least one episode of incontinence a week

You may not qualify if:

• severe diarrhea
• on opioids, tricyclics (except on stable doses \> 3months)
• active depression
• comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy
• neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury)
• impaired cognizance (mini mental score of \< 15) and/or legally blind
• metal implants, pacemakers
• previous pelvic surgery, bladder repair, radical hysterectomy
• ulcerative and Crohn's colitis
• rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids
• pregnant women or nursing mothers

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30907, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Biofeedback, Psychology

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

Study Officials

• Satish Rao, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Everyone is masked to the assignment of home or office biofeedback training. Once the subject makes it to their treatment session, then everyone will know which one the subject has been allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division Chief Fellowship Program Director Director, Digestive Health Center

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: July 13, 2017
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: September 30, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)