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Home Versus Office Biofeedback Therapy for Fecal Incontinence

NCT03216291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-08-06

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Satish Rao, MD, PhD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-03-31
Completion
2019-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216291 on ClinicalTrials.gov