Home Versus Office Biofeedback Therapy for Fecal Incontinence
Completed · Not applicable
Conditions studied: Fecal Incontinence
In brief
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.
Key facts
- Study ID
- NCT03216291
- Run by
- Augusta University
- People needed
- 33
- Starts
- 2015-10-01
- Expected to finish
- 2019-09-30
- Last updated by the study team
- 2020-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Augusta University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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