NCT02609607

Treating Anorectal Dysfunction in MS

Treating Anorectal Dysfunction Associated With Multiple Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: David Levinthal · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation
• Fecal Incontinence
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Bisacodyl	Rectal suppository
OTHER	Placebo	Rectal suppository

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2015-11-20
• Last updated: 2020-01-22
• Results posted: 2020-01-22

Locations

1 site across 1 country: United States