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
|Condition or disease||Intervention/treatment||Phase|
|Constipation Fecal Incontinence Multiple Sclerosis||Drug: Bisacodyl Other: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Placebo Comparator: Placebo
Every other day placement of a placebo rectal suppository for 4 weeks
Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks
Other Name: Dulcolax
- 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.
- 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.
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
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||David J Levinthal, MD, PhD||University of Pittsburgh|