Fecal Incontinence Clinical Trial
Official title:
Home Versus Office Biofeedback Therapy for Fecal Incontinence
Verified date | August 2020 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | September 30, 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires | 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 | six weeks | |
Secondary | Anal sphincter pressure and rectal sensation | Assess the changes in anal resting and squeeze sphincter pressures (mmHg) and sensory data between baseline anorectal manometry study and study done at the end of treatment and compare between the 2 treatment groups. | six weeks | |
Secondary | FI severity, quality of life and bowel symptoms | The FI severity and quality of life and bowel symptoms will be assessed using ICIQ-B, FISS, FISI questionnaires (numerical mean scores for individual questions or groups of questions) and compared between two groups. | Six weeks | |
Secondary | Treatment compliance with home biofeedback | The treatment compliance will be assessed by examining daily logs of computer which includes the duration and completion of each home biofeedback session. | Six weeks |
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