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Treating Anorectal Dysfunction in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609607
Recruitment Status : Terminated (Poor enrollment; funding ending Dec 31, 2018.)
First Posted : November 20, 2015
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Consortium of Multiple Sclerosis Centers
Information provided by (Responsible Party):
David Levinthal, University of Pittsburgh

Brief Summary:
The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. Patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.

Condition or disease Intervention/treatment Phase
Constipation Fecal Incontinence Multiple Sclerosis Drug: Bisacodyl Other: Placebo Phase 2

Detailed Description:

The majority of patients with multiple sclerosis (MS) suffer from some form of anorectal dysfunction, and these difficulties with bowel function are often ranked as negatively impactful on quality of life as impaired mobility. Despite the significant clinical burden of these symptoms, there remains a paucity of published literature supporting specific therapeutic options to manage anorectal dysfunction in this clinical population. Most bowel regimens rely on either oral laxatives (i.e. PEG-3350) or anti-diarrheal agents (i.e. loperamide). In their study, the investigators propose to establish the efficacy of a bowel regimen that combines both oral agents (as needed; standard care) with scheduled, every other day dosing of a placebo or stimulant laxative rectal suppository -- bisacodyl 10 mg.

Bisacodyl is a stimulant laxative medication that is available over-the-counter. It works by activating nerves in the rectum to elicit rectal contractions which ultimately leading to defecation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treating Anorectal Dysfunction Associated With Multiple Sclerosis
Study Start Date : June 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bisacodyl

Arm Intervention/treatment
Placebo Comparator: Placebo
Every other day placement of a placebo rectal suppository for 4 weeks
Other: Placebo
Rectal suppository

Experimental: Bisacodyl
Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks
Drug: Bisacodyl
Rectal suppository
Other Name: Dulcolax




Primary Outcome Measures :
  1. Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks [ Time Frame: Baseline, 4 weeks ]

    All subjects were asked the following question at study entry ('baseline') and the end of 4 weeks of intervention: "Using a scale of 1 to 10 (1 being no problem and 10 being maximally impactful symptoms), how would you rate the severity of your bowel symptoms over the past 2 weeks?"

    The range of reported values was 2-9. We took a response to be a 30% decrease (i.e. improvement) in the subjective symptom score between the baseline and 4 week assessment.



Secondary Outcome Measures :
  1. Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) is a validated measure of constipation severity. The questionnaire has a total score and three subscales: Abdominal Symptoms, Rectal Symptoms, and Stool Form. The mean total score and each of the scale subscores are reported in a range of 0-4, with higher scores meaning worse outcomes. A difference (number) of 0.75 in the mean PAC-SYM total and each of the subscale scores is regarded as a clinically significant change.

  2. Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks [ Time Frame: Baseline, 4 Weeks ]
    The Fecal Incontinence Severity Index (FISI) is measures of fecal incontinence severity. The FISI score ranges from 0 to 61, with higher scores interpreted as worse fecal incontinence severity.

  3. Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    The Fecal Incontinence Quality of Life (FIQL) Scale measures of the impact of fecal incontinence on aspects of quality of life. There are 4 subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment, each of which is calculated as an average score ranging from 1 to 5, with higher scores indicating a greater functional status of quality of life.

  4. Change From Baseline in PAC-QOL Scores at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    The Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire is a validated measure of the quality of life impact of constipation. The questionnaire is reported a total score, reported as the average item scores and ranging from 0 to 4, where higher scores represent poorer QOL.

  5. Change From Baseline in SF-36 Scores at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    The RAND Health Survey (v.1) is a 36 item questionnaire that measures health in multiple domains. The measure is reported as scores on eight subscales: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, and General health. Scores on each subscale range from 0 and 100, with higher scores indicative of better health function in the domain.

  6. Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    The Bristol Stool Scale (BSS) is a validated measure of stool form, ranging from 1-7. Normal stool form is regarded as average scores of 3 to 4. Subjects were asked to assess the BSS in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention, but these 'bowel diaries' were not required for entry into the trial.

  7. Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    Subjects were asked to record each bowel movement in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the average difference in number of bowel movements / day before and after exposure to placebo or Bisacodyl. However, these 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl.

  8. Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks [ Time Frame: Baseline, 4 weeks ]
    Subjects were asked to record each episode of fecal incontinence in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the mean difference in the average number of fecal incontinence episodes / day.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale [MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score [EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of MS disease modifying therapy, or comorbid medical condition AND who also have anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.

Exclusion Criteria:

  • MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative proctitis, ulcerative colitis) will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609607


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
David Levinthal
Consortium of Multiple Sclerosis Centers
Investigators
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Principal Investigator: David J Levinthal, MD, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by David Levinthal, University of Pittsburgh:

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Responsible Party: David Levinthal, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02609607    
Other Study ID Numbers: PRO15100104
First Posted: November 20, 2015    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fecal Incontinence
Multiple Sclerosis
Sclerosis
Constipation
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives