Clinical trial NCT02609607: Treating Anorectal Dysfunction in MS
Official title: Treating Anorectal Dysfunction Associated With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Constipation
Fecal Incontinence
Multiple Sclerosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Consortium of Multiple Sclerosis Centers
First posted: 2015-11-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks
timeFrame: Baseline, 4 Weeks
measure: Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline in PAC-QOL Scores at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline in SF-36 Scores at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks
timeFrame: Baseline, 4 weeks
measure: Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David J Levinthal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: