Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Anorectal Dysfunction in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Consortium of Multiple Sclerosis Centers
Information provided by (Responsible Party):
David Levinthal, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Constipation
Fecal Incontinence
Multiple Sclerosis
Interventions Drug: Bisacodyl
Other: Placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Period Title: Overall Study
Started 6 5
Completed 6 4
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Placebo Bisacodyl Total
Hide Arm/Group Description

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
5
 100.0%
8
  72.7%
>=65 years
3
  50.0%
0
   0.0%
3
  27.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
62.3  (6.3) 58  (5.2) 60.6  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
4
  66.7%
3
  60.0%
7
  63.6%
Male
2
  33.3%
2
  40.0%
4
  36.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
Hide Description

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.

Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
0
   0.0%
2.Secondary Outcome
Title Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change in PAC-SYM Total Score -0.24  (0.36) 0.06  (0.49)
Change in Abdominal Symptoms 0  (0.16) 0.13  (0.48)
Change in Rectal Subscale 0  (0.76) -0.42  (0.63)
Stool Subscale 0  (1.30) -0.05  (0.19)
3.Secondary Outcome
Title Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.83  (7.9) 4.25  (19.4)
4.Secondary Outcome
Title Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Lifestyle -0.32  (0.41) -0.1  (0.03)
Coping / Behavior -0.22  (0.65) -0.06  (0.17)
Depression/ Self-Perception -0.17  (0.36) 0.07  (0.21)
Embarrassment -0.44  (0.62) 0.17  (0.69)
5.Secondary Outcome
Title Change From Baseline in PAC-QOL Scores at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.04  (0.23) -0.33  (0.44)
6.Secondary Outcome
Title Change From Baseline in SF-36 Scores at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical functioning 3.33  (7.45) -1.25  (5.45)
Role limitations due to physical health -16.67  (23.57) -12.5  (21.65)
Role limitations due to emotional problems -7.33  (37.8) 16.5  (16.5)
Energy/fatigue -4.17  (3.44) -6.25  (7.4)
Emotional well-being -5.33  (7.89) -1  (1.73)
Social functioning -4.5  (17.22) 0  (8.49)
Pain 13.67  (19.94) -1.75  (4.92)
General health -4.17  (3.44) -3.75  (9.60)
7.Secondary Outcome
Title Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Comparative data was available for only 3 of the 6 subjects randomized to placebo, and only 1 of the 4 subjects randomized to receive Bisacodyl.
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: bowel movements per day
0.02  (0.70) -0.21  (0.33)
9.Secondary Outcome
Title Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description:

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: incontinence episodes per day
0.05  (0.16) -0.04  (0.32)
Time Frame During trial duration (4 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Bisacodyl
Hide Arm/Group Description

Every other day placement of a placebo rectal suppository for 4 weeks

Placebo: Rectal suppository

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository

All-Cause Mortality
Placebo Bisacodyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Placebo Bisacodyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Bisacodyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/5 (20.00%)    
Gastrointestinal disorders     
Abdominal cramps *  0/6 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
Early Termination due to Difficulty in Recruitment, leading to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Levinthal
Organization: University of Pittsburgh Medical Center
Phone: 14123030525
EMail: levinthald@upmc.edu
Layout table for additonal information
Responsible Party: David Levinthal, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02609607    
Other Study ID Numbers: PRO15100104
First Submitted: November 16, 2015
First Posted: November 20, 2015
Results First Submitted: November 4, 2019
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020