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Home Versus Office Biofeedback Therapy for Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT03216291
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Satish Rao, Augusta University

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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Behavioral: biofeedback therapy Device: Home Biofeedback therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Home Versus Office Biofeedback Therapy for Fecal Incontinence
Study Start Date : October 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Home Biofeedback
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
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.

Active Comparator: Office biofeedback
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
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.
Other Name: Training




Primary Outcome Measures :
  1. number of episodes of fecal incontinence [ Time Frame: six weeks ]
    Assess the change in the No of FI episodes between baseline week and end of study week and compare between the two treatment groups

  2. Squeeze anal sphincter pressure [ Time Frame: six weeks ]
    assess the change in anal squeeze sphincter pressure (mm Hg) between baseline anorectal manometry study and study done at the end of treatment and compare between the 2 treatment groups


Secondary Outcome Measures :
  1. Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires [ Time Frame: six weeks ]
    assess the change in 4 quality of life domains between baseline SF-11 survey and survey done at the end of treatment and compare between the 2 treatment groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216291


Contacts
Contact: Satish Rao, MD, PhD 7067212238 srao@augusta.edu
Contact: Rachael Parr, MPH 7067211968 rparr@augusta.edu

Locations
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30907
Contact: Ijeoma Azih, MBBS    706-721-1968    iazih@augusta.edu   
Principal Investigator: Satish SC Rao, MD, PhD         
Sponsors and Collaborators
Augusta University

Responsible Party: Satish Rao, Professor of Medicine, Division Chief Fellowship Program Director Director, Digestive Health Center, Augusta University
ClinicalTrials.gov Identifier: NCT03216291     History of Changes
Other Study ID Numbers: HomeVOfficeFI
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases