Educational-Medical-Behavioral Treatment of Fecal Incontinence

Summary

In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.

Conditions

• Fecal Incontinence

Interventions

OTHER

Education

Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.

DIETARY_SUPPLEMENT

Fiber supplements

Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.

DRUG

Laxatives or anti-diarrheals

Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed. Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.

BEHAVIORAL

Pelvic floor muscle exercises

Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.

BEHAVIORAL

Tips on how to prevent fecal incontinence

Examples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze".

BEHAVIORAL

Daily diary

Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.

OTHER

Protective pads or garments

In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• William E Whitehead, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations