Treatment of Patients With Fecal Incontinence

NCT00292318 | Terminated Results

• 1 other identifier: CLIN-013-05S
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

adequate relief; anorectal manometry; biofeedback therapy; fecal incontinence

Outcome Measures

Primary Outcomes (1)

• Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer.

  Only reporting the results of participants who reported adequate relief.

  The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.

Secondary Outcomes (1)

• Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)

  The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.

Behavioral: control group

Arm 2

EXPERIMENTAL

Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.

Behavioral: Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study

Interventions

Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study BEHAVIORAL

Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.

Arm 2

control group BEHAVIORAL

Medical counseling and ano-sphinctal exercises.

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient with inadequate relief of fecal incontinence symptoms after documented management in the primary care setting. They must have:
• a mini-mental status score of \> 18
• an "up and go" test score of \< 30 seconds
• bowel habit diary showing \> one episode of fecal incontinence episode per week

You may not qualify if:

• patients who previously underwent a course of biofeedback for fecal incontinence
• age \< 18 years
• major neurological disease
• significant cognitive impairment (mini mental status examination score \< 18), functional impairment (up and go score of \> 30 seconds)
• active inflammatory bowel disease
• history of spinal cord injury
• rectal resection
• ileal pouch procedures
• latex allergy
• significantly distressed and unable to consider informed consent issues adequately
• needing urgent medical referral
• insufficient written English skills to complete the questionnaires
• require surgery

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Links

• One of the family of web sites by the international Organization for Functional Gastrointestinal Disorders (IFFGD)

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Biofeedback, Psychology; Control Groups

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Felix W. Leung, MD
• Organization: Greater Los Angeles VA Medical Center

felix.leung@va.gov

818-891-7711

Study Officials

• Felix W Leung, MD

  VA Greater Los Angeles Healthcare System, Sepulveda, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: January 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2014
• Last Updated: August 19, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-08

Locations

US (1)