Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292318
Status:
TERMINATED
Last Update Posted:
2015-08-19
First Post:
2006-02-13
Brief Title:
Treatment of Patients With Fecal Incontinence
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Biofeedback Therapy for Fecal Incontinence a Randomized Control Trial
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to continue due to medical equipment necessary for research study was removed from facility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if a behavioral treatment method called biofeedback will reduce the frequency of episodes of leakage of fecal material in patient suffering from fecal incontinence
Detailed Description:
Fecal incontinence FI is a devastating condition that causes psychological stress shame embarrassment and social isolation It has a major impact on quality of life of patients and their families It complicates medical illnesses and management has major economic consequences and can contribute to early nursing home placement Although FI affects 22 to 11 of the general population the magnitude of the problem is underestimated since most patients do not discuss this silent affliction with their care providers In uncontrolled studies of biofeedback for FI including our preliminary observations in male veterans without anal sphincter injury improvement was observed in up to 80 of patients However it may not be appropriate for all patients One recent randomized controlled trial in predominantly 93 women female patients many 60 with post-obstetrical anal sphincter injury reports that biofeedback is no more effective than medical therapy alone The trial provides data for the formulation of an evidence-based approach to treat FI in female veterans There are no randomized controlled data on the effectiveness of biofeedback for FI in male patients A randomized controlled trial is needed to assess the effectiveness of multi-component biofeedback therapy versus standard medical therapy in man The immediate objectives of the current proposal are to evaluate the effectiveness of biofeedback treatment for FI and to identify baseline patient characteristics that will predict improvement and adequate relief in FI symptoms following treatment This will lead directly to our long-term goal of providing optimal treatment for FI by tailoring biofeedback plus medical therapy to each patients needs based on sound clinical evidence This project is a prospective randomized controlled clinical trial comparing two treatments for FI among patients who have failed medical treatment under the care of their primary care providers and are referred for evaluation and management of current FI As part of standard care all referred patients will receive a history and physical examination including medical surgical FI-specific symptoms and physical findings general mobility mental status and anorectal examination Those who meet inclusion criteria and who agree to participate will be randomly assigned to one of 2 study arms 1 medical therapy alone 2 medical therapy sphincter strength sensation coordination training Baseline data will also include adequate relief measure incontinence scores based on bowel habit diary anorectal parameters based on manometric and sensory testing general and FI-specific quality of life depression anxiety and expectation of improvement following treatment All questionnaires will be based on published validated instruments Patients will be treated in six biweekly sessions 3 months Medical therapy six 40 - 60 minute sessions includes advice medication for constipationdiarrhea and instruction related to empiric anal sphincter exercises group 1 Biofeedback treatment six 40 - 60 minute sessions includes medical therapy plus all components of biofeedback groups 2 Follow up data will be obtained in all patients at the end of treatment 3 months and by mailed questionnaires at 12 months after completion of treatment or dropout We can determine if biofeedback plus medical therapy will be superior to medical therapy alone in providing FI symptom relief The possibility that more patients will report relief of FI symptoms when specific deficits detected at baseline testing shows improvement with treatment The influence of co-variables on results of treatment can also be determined Our long term goal is to develop a clinically relevant strategy that will be cost-effect for the management of FI in VA patients predominantly male within the organizational frame work of primary and subspecialty care If biofeedback treatment is proven to be effective and VA patients can be offered therapy components with optimal likelihood of success the obvious benefit to our VA patients is abatement of the silent affliction of FI and improvement in patient satisfaction and quality of life Further study will focus on a multi-site cooperative study to assess which component of biofeedback is most instrumental in bringing about improvement and relief in patients with specific deficits
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