Treatment of Patients With Fecal Incontinence

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.

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