Phase
Condition
Rectal Disorders
Bowel Dysfunction
Fecal Incontinence
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years
Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal materialthat occurs at least monthly over the last 3 months that is bothersome enough todesire treatment
Exclusion
Exclusion Criteria:
Stool consistency over the last 3 months that includes items 1 or 7 based on theBristol Stool form scale
Current or past diagnosis of colorectal or anal malignancy
Diagnosis of inflammatory bowel disease
Current or history of rectovaginal fistula or cloacal defect
Rectal prolapse (mucosal or full thickness)
Prior removal or diversion of any portion of colon or rectum
Prior pelvic floor or abdominal radiation
Refusal or inability to provide written consent
Inability to conduct telephone interviews conducted in English or Spanish
Fecal impaction by exam
Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond thehymen who are currently using a pessary are eligible
Incontinence only to flatus
Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in thelast 30 days
Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months
Current supervised anal sphincter exercise/pelvic floor muscle training withbiofeedback
Previously received and failed treatment of fecal incontinence using supervised analsphincter exercise/pelvic floor muscle training with biofeedback
Previous allergy or intolerance to loperamide
Pregnant, nursing, or planning to become pregnant before the end of the studyfollow-up period.
Childbirth within the last 3 months
Currently taking anti-retroviral drugs
Neurological disorders known to affect continence, including spinal cord injury,advanced multiple sclerosis or Parkinson's disease and debilitating stroke
Known diagnosis of hepatic impairment
Chronic abdominal pain in the absence of diarrhea
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
University of California at San Diego
La Jolla, California 92037-0974
United StatesSite Not Available
Kaiser San Diego
San Diego, California 92110
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87131
United StatesSite Not Available
Duke University
Durham, North Carolina 27707
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19118
United StatesSite Not Available
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Brown/Women and Infants Hospital of Rhode Island
Providence, Rhode Island 02903
United StatesSite Not Available
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