Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124904
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2005-07-27
Brief Title:
Biofeedback for Fecal Incontinence
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Biofeedback for Fecal Incontinence and Constipation
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fecal incontinence affects 2 of adults in the United States Biofeedback has been recommended for the treatment of fecal incontinence because uncontrolled studies over the past 25 years suggest that these treatments are as effective as medical or surgical management and involve no risk However placebo-controlled trials are still lacking
The aims of this study are 1 to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit 2 to identify which patients are most likely to benefit and 3 to assess the impact of treatment on quality of life
The aims of this study are 1 to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit 2 to identify which patients are most likely to benefit and 3 to assess the impact of treatment on quality of life
Detailed Description:
Study I is a long-term prospective single-blind study comparing biofeedback for fecal incontinence to a standard therapy Kegel exercises that is associated with a similar expectation of improvement ie comparable placebo effect Prior to randomization patients will receive medical therapy antidiarrheal medications as appropriate and education for 4 weeks and only patients who remain incontinent will be randomized Anal canal squeeze pressures and rectal sensory thresholds will be tested before and after treatment Patients will keep a diary throughout baseline and treatment and they will be re-assessed at 3 6 and 12 months Treatment will consist of 6 clinic visits at 2-week intervals The primary outcome is the patients response to the question Have you had satisfactory relief of fecal incontinence yesno This question is asked at 3 months following the end of treatment and at each follow-up visit The investigators will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None