Treating Anorectal Dysfunction in MS
Treating Anorectal Dysfunction Associated With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Poor enrollment; funding ending Dec 31, 2018.
What was tested
Treatment tested
- Bisacodyl
Unknown
Placebo
- Placebo
Results by group
Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
Baseline, 4 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 2 Participants | 6 | |
| Bisacodyl | 0 Participants | 4 |
Placebo
Bisacodyl
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 6 | 0 (0.0%) | 0 |
| Bisacodyl | 5 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual function
Other measures (8)
Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual functionChange From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks
Baseline, 4 Weeks
Bladder, bowel and sexual functionChange From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual functionMood and sleepQuality of life (reported by participants)Change From Baseline in PAC-QOL Scores at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual functionQuality of life (reported by participants)Change From Baseline in SF-36 Scores at 4 Weeks
Baseline, 4 weeks
FatiguePainQuality of life (reported by participants)Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual functionChange From Baseline In Average Number of Daily Bowel Movements at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual functionChange From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks
Baseline, 4 weeks
Bladder, bowel and sexual function
Who could take part
MS (type not specified) · 18 to 80
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jun 2016
Main results due
Nov 2018
Finished
Dec 2018
Results posted
Jan 2020