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Completed

NCT Number: NCT00884832

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI. During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant "idiopathic" FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and sensation will be evaluated before and during treatment with clonidine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clonidine

Drug

Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.

Other names: Kapvay, Nexiclon, Catapres

Placebo

Drug

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.

Primary outcomes

  1. Mean Fecal Incontinence and Constipation Assessment (FICA) Score

    Time frame: 4 weeks baseline, 4 weeks treatment

    The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.

Secondary outcomes

  1. Mean Number of Days With Fecal Incontinence

    Time frame: 4 weeks baseline, 4 weeks treatment

    Values were averaged over 4 week baseline and 4 week treatment periods.

  2. Mean Number of Fecal Incontinence Episodes

    Time frame: 4 weeks baseline, 4 weeks treatment

    Values were averaged over 4 week baseline and 4 week treatment periods.

  3. Mean Percentage of Bowel Movements Which Were Incontinent

    Time frame: 4 weeks baseline, 4 weeks treatment

    Values were averaged over 4 week baseline and 4 week treatment periods.

  4. Mean Severity of Fecal Incontinence

    Time frame: 4 weeks baseline, 4 weeks treatment

    The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.

  5. Impact of Fecal Incontinence on Baseline Quality of Life

    Time frame: 4 weeks baseline

    Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).

    Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).

  6. Impact of Fecal Incontinence on Post-Treatment Quality of Life

    Time frame: after 4 weeks treatment

    Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).

    Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).

  7. Satisfaction With Treatment

    Time frame: 4 weeks baseline, 4 week treatment

    This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = "Not satisfied at all (no relief of symptoms)" to 100 = "Completely satisfied (symptoms resolved)." The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.

  8. Percentage of Bowel Movements Preceded by Rectal Urgency

    Time frame: 4 weeks baseline, 4 weeks treatment

    Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.

  9. Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea

    Time frame: 4 weeks baseline, 4 weeks treatment

    The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.

  10. Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline

    Time frame: 4 weeks treatment

    The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.

  11. Percentage of Days With Fecal Incontinence (FI)

    Time frame: 4 weeks baseline, 4 weeks treatment

  12. Percentage of Days With FI Post-treatment Adjusted for Baseline

    Time frame: 4 weeks treatment

    The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2009
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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