Treating Anorectal Dysfunction in MS
Status: | Terminated |
---|---|
Conditions: | Constipation, Neurology, Neurology, Gastrointestinal, Multiple Sclerosis |
Therapuetic Areas: | Gastroenterology, Neurology, Other |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 12/9/2018 |
Start Date: | June 2016 |
End Date: | December 2018 |
Treating Anorectal Dysfunction Associated With Multiple Sclerosis
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.
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.
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.
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.
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.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Phone: 412-864-7075
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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