A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Intervention: Clonidine; Placebo
Intervention description: Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.; Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: fecal incontinence; stool leakage; incontinence; FI; Urge predominant fecal incontinence

Summary:

      Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic
      are doing a research study to assess the effects of a medication, clonidine, on fecal
      incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug
      Administration (FDA) for treating high blood pressure, but not for treating incontinence and
      rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence,
      increase rectal capacity and reduce rectal sensation to a greater extent than placebo in
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-75 years with urge predominant FI, as defined by a validated
             questionnaire, for greater than or equal to 1 year duration will be eligible to
             participate

          -  Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by
             colonoscopy, or barium enema and sigmoidoscopy within the last 3 years

        Exclusion Criteria:

          -  History of clinically significant cardiovascular or pulmonary disease or EKG
             abnormalities within the last 6 months [i.e., atrial flutter or fibrillation, sinus
             tachycardia (> 110/minute) or bradycardia (< 45 beats/minute), or prolonged corrected
             QT (QTc) interval (> 460 msec)

          -  Current or past history of rectal cancer, scleroderma, inflammatory bowel disease,
             congenital anorectal abnormalities, greater than or equal to Grade 2 rectal prolapse,
             history of rectal resection or pelvic irradiation

          -  Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score
             <20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy

          -  Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or
             systolic blood pressure of <100 mm Hg on initial screening visit

          -  Pregnant or nursing women

          -  Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily
             (Bristol 6 or 7)

          -  Medications: Absolute - opioid analgesics, anticholinergic drugs [low doses of
             tricyclic antidepressants, e.g., nortriptyline (up to 50 mg/day) or amitriptyline (up
             to 25 mg/day) will be permitted provided they were begun 3 months prior to the
             screening period]

          -  Medications: Relative - other antihypertensive agents (i.e., if there is concern about
             synergistic effects and hypotension)