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Treating Anorectal Dysfunction in MS

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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

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 20, 2015
Results First Submitted Date  ICMJE November 4, 2019
Results First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 22, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
Global Subjective Assessment PRO [ Time Frame: 4 weeks ]
"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?"
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Bowel Function (Bristol Stool Scale) [ Time Frame: 4 weeks ]
    Daily Bowel Diaries - patients will record the consistency of each stool using the Bristol Stool Scale (numerical coded scale 1-7) during the study period.
  • Bowel Function (daily number of bowel movements) [ Time Frame: 4 weeks ]
    Daily Bowel Diaries - daily number of bowel movements (BM) will be recorded during the study period.
  • Bowel Function (daily number of fecal incontinence (FI) episodes) [ Time Frame: 4 weeks ]
    Daily Bowel Diaries - daily number of fecal incontinence (FI) episodes will be recorded during the study period.
  • Constipation Severity (PAC-SYM) [ Time Frame: 4 weeks ]
    Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM)
  • Fecal Incontinence Severity (FISI) [ Time Frame: 4 weeks ]
    Fecal Incontinence Severity Index (FISI)
  • Quality of Life (SF-36) [ Time Frame: 4 weeks ]
    SF-36
  • Constipation-Related Quality of Life (PAC-QOL) [ Time Frame: 4 weeks ]
    Patient Assessment of Constipation QOL (PAC-QOL)
  • Fecal Incontinence-Related Quality of Life (FIQL) [ Time Frame: 4 weeks ]
    Rockwood Fecal Incontinence Quality of Life Scale (FIQL)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Anorectal Dysfunction in MS
Official Title  ICMJE Treating Anorectal Dysfunction Associated With Multiple Sclerosis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Constipation
  • Fecal Incontinence
  • Multiple Sclerosis
Intervention  ICMJE
  • Drug: Bisacodyl
    Rectal suppository
    Other Name: Dulcolax
  • Other: Placebo
    Rectal suppository
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Every other day placement of a placebo rectal suppository for 4 weeks
    Intervention: Other: Placebo
  • Experimental: Bisacodyl
    Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks
    Intervention: Drug: Bisacodyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
70
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609607
Other Study ID Numbers  ICMJE PRO15100104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Levinthal, University of Pittsburgh
Study Sponsor  ICMJE David Levinthal
Collaborators  ICMJE Consortium of Multiple Sclerosis Centers
Investigators  ICMJE
Principal Investigator: David J Levinthal, MD, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP