Treatment of Patients With Fecal Incontinence

Condition(s) targeted: Fecal Incontinence

Intervention: Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study (Behavioral); control group (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Felix W. Leung, Principal Investigator, Affiliation: VA Greater Los Angeles Healthcare System, West LA

Overall contact:
Nora J Jamgotchian, Phone: (818) 895-9426, Email: nora.jamgotchian@va.gov

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.

Official title: Biofeedback Therapy for Fecal Incontinence a Randomized Control Trial

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Patient report of "adequate relief" from FI symptoms with a "yes" or "no" answer will be used as primary outcome variable. Data will be recorded at baseline and end of treatment. A "responder" will be defined as one who provides a "yes

Secondary outcome: Change in anorectal physiologic tests (absolute squeeze pressure), change in bowel symptoms and number of days with or without FI, change in continence, SF 36 generic measure of HRQOL and health scores, FI-specific QOL score, and HAD score.

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 2. 2% 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 patient's 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 constipation/diarrhea, 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 deficit(s) detected at baseline testing show(s) 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Nora J Jamgotchian, Phone: (818) 895-9426, Email: nora.jamgotchian@va.gov

VA Greater Los Angeles Healthcare System, West LA, West Los Angeles, California 90073, United States; Recruiting
Nora J Jamgotchian, Phone: 818-895-9426, Email: nora.jamgotchian@va.gov
Felix W Leung, Phone: (818) 891-7711, Email: Felix.Leung@va.gov
Felix W. Leung, Principal Investigator

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

Starting date: January 2008
Ending date: September 2010
Last updated: July 22, 2009