Trial Outcomes & Findings for Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe) (NCT NCT02008565)
NCT ID: NCT02008565
Last Updated: 2018-11-20
Results Overview
The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
12 and 24 weeks
Results posted on
2018-11-20
Participant Flow
Participant milestones
| Measure |
Loperamide - Exercise Plus Biofeedback
Participants receive loperamide drug and anal exercise with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
Participants receive placebo drug and anal exercise with biofeedback intervention.
|
Loperamide - Education Only
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
84
|
88
|
42
|
|
Overall Study
COMPLETED
|
85
|
83
|
86
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Loperamide - Exercise Plus Biofeedback
Participants receive loperamide drug and anal exercise with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
Participants receive placebo drug and anal exercise with biofeedback intervention.
|
Loperamide - Education Only
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
0
|
Baseline Characteristics
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Baseline characteristics by cohort
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=86 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
63.6 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
296 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
265 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
|
Vaginal deliveries, median [min, max]
|
2.0 Vaginal deliveries
n=5 Participants
|
2.0 Vaginal deliveries
n=7 Participants
|
2.0 Vaginal deliveries
n=5 Participants
|
2.0 Vaginal deliveries
n=4 Participants
|
2.0 Vaginal deliveries
n=21 Participants
|
|
Cesarean deliveries, median [min, max]
|
0.0 Cesarean deliveries
n=5 Participants
|
0.0 Cesarean deliveries
n=7 Participants
|
0.0 Cesarean deliveries
n=5 Participants
|
0.0 Cesarean deliveries
n=4 Participants
|
0.0 Cesarean deliveries
n=21 Participants
|
|
Menstrual status, No. (%)
Not Sure
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Menstrual status, No. (%)
Post-menopausal
|
74 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Menstrual status, No. (%)
Pre-menopausal
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Currently using estrogen therapy, No. (%)
Oral/Patch
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Currently using estrogen therapy, No. (%)
Vaginal
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Currently using estrogen therapy, No. (%)
Not currently using estrogen therapy
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Current smoker, No. (%)
Current smoker
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Current smoker, No. (%)
Not current smoker
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Connective tissue disease, No. (%)
Connective tissue disease
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Connective tissue disease, No. (%)
Does not have connective tissue disease
|
82 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
284 Participants
n=21 Participants
|
|
Prior accidental bowel leakage surgery, No. (%)
Prior accidental bowel leakage surgery
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Prior accidental bowel leakage surgery, No. (%)
No prior accidental bowel leakage surgery
|
82 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
283 Participants
n=21 Participants
|
|
Prior rectal or anal surgery, No. (%)
Prior rectal or anal surgery
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Prior rectal or anal surgery, No. (%)
No prior rectal or anal surgery
|
72 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
|
Prior hysterectomy, No. (%)
Prior hysterectomy
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Prior hysterectomy, No. (%)
No prior hysterectomy
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Prior urinary incontinence surgery, No. (%)
Prior urinary incontinence surgery
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Prior urinary incontinence surgery, No. (%)
No prior urinary incontinence surgery
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Prior pelvic organ prolapse surgery, No. (%)
Prior pelvic organ prolapse surgery
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Prior pelvic organ prolapse surgery, No. (%)
No prior pelvic organ prolapse surgery
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
BMI, mean (SD)
|
30.1 kg/m^2
STANDARD_DEVIATION 7.4 • n=5 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 6.7 • n=7 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 10.4 • n=4 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 7.8 • n=21 Participants
|
|
Bristol Stool Index, No. (%)
Type 2 (Sausage shaped but lumpy)
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Bristol Stool Index, No. (%)
Type 3 (Like a sausage or snake but with cracks on
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Bristol Stool Index, No. (%)
Type 4 (Like a sausage or snake, smooth and soft)
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Bristol Stool Index, No. (%)
Type 5 (Soft blobs with clear cut edges)
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Bristol Stool Index, No. (%)
Type 6 (Fluffy pieces with ragged edges, a mushy s
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=86 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline St. Mark's (Vaizey) Score
12 Week St. Mark's Score
|
-5.5 units on a scale
Interval -7.2 to -3.9
|
-4.4 units on a scale
Interval -6.0 to -2.8
|
-4.5 units on a scale
Interval -6.1 to -2.9
|
-3.4 units on a scale
Interval -6.0 to -0.8
|
|
Change From Baseline St. Mark's (Vaizey) Score
24 Week St. Mark's Score
|
-9.7 units on a scale
Interval -11.9 to -7.5
|
-5.9 units on a scale
Interval -8.1 to -3.7
|
-6.2 units on a scale
Interval -8.1 to -4.2
|
-4.5 units on a scale
Interval -7.1 to -1.9
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Change = (Week \[12, 24\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=86 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)
12 Week CRADI Score
|
-16.3 units on a scale
Interval -22.4 to -10.1
|
-13.1 units on a scale
Interval -19.2 to -7.1
|
-16.9 units on a scale
Interval -22.8 to -11.1
|
-4.6 units on a scale
Interval -14.2 to 5.1
|
|
Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)
24 Week CRADI Score
|
-21.5 units on a scale
Interval -27.6 to -15.4
|
-15.7 units on a scale
Interval -21.7 to -9.6
|
-21.7 units on a scale
Interval -27.6 to -15.9
|
-15.7 units on a scale
Interval -25.4 to -5.9
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[12, 24\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=86 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score
12 Weeks
|
-12.5 units on a scale
Interval -18.5 to -6.4
|
-10.8 units on a scale
Interval -16.8 to -4.9
|
-15.8 units on a scale
Interval -21.6 to -9.9
|
-12.3 units on a scale
Interval -21.9 to -2.8
|
|
Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score
24 Weeks
|
-41.3 units on a scale
Interval -57.9 to -24.6
|
-32.4 units on a scale
Interval -48.8 to -15.9
|
-41.6 units on a scale
Interval -57.8 to -25.4
|
-17.3 units on a scale
Interval -26.9 to -7.8
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of accident-free days at 12 and 24 weeks and the number of accident-free days at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=82 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=85 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Accident-free Days at 12 and 24 Weeks
12 Weeks
|
1.8 accident-free days
Interval 1.1 to 2.5
|
1.9 accident-free days
Interval 1.2 to 2.6
|
1.7 accident-free days
Interval 1.0 to 2.4
|
1.4 accident-free days
Interval 0.2 to 2.5
|
|
Change From Baseline Accident-free Days at 12 and 24 Weeks
24 Weeks
|
2.5 accident-free days
Interval 1.8 to 3.2
|
1.9 accident-free days
Interval 1.2 to 2.5
|
1.7 accident-free days
Interval 1.0 to 2.4
|
2.1 accident-free days
Interval 0.9 to 3.3
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per day resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=82 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=85 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks
12 Weeks
|
-0.4 pad-change leaks per day
Interval -0.7 to -0.1
|
-0.2 pad-change leaks per day
Interval -0.4 to 0.1
|
-0.3 pad-change leaks per day
Interval -0.5 to 0.0
|
-0.2 pad-change leaks per day
Interval -0.7 to 0.2
|
|
Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks
24 Weeks
|
-0.5 pad-change leaks per day
Interval -0.8 to -0.2
|
-0.1 pad-change leaks per day
Interval -0.4 to 0.2
|
-0.4 pad-change leaks per day
Interval -0.7 to -0.1
|
-0.4 pad-change leaks per day
Interval -0.8 to 0.1
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=82 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=85 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks
12 Weeks
|
-2.7 pad-change leaks per week
Interval -4.5 to -0.9
|
-1.1 pad-change leaks per week
Interval -2.9 to 0.6
|
-1.3 pad-change leaks per week
Interval -3.1 to 0.4
|
-1.7 pad-change leaks per week
Interval -4.8 to 1.3
|
|
Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks
24 Weeks
|
-3.3 pad-change leaks per week
Interval -5.2 to -1.5
|
-0.7 pad-change leaks per week
Interval -2.5 to 1.0
|
-2.2 pad-change leaks per week
Interval -3.9 to -0.4
|
-2.5 pad-change leaks per week
Interval -5.6 to 0.5
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in daily average FI episodes at 12 and 24 weeks and the daily average FI episodes at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at 3 complete days, not necessarily consecutive, for follow-up diaries).
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=85 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=82 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=85 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks
12 Weeks
|
-1.1 leaks per day
Interval -1.6 to -0.6
|
-0.7 leaks per day
Interval -1.2 to -0.2
|
-0.9 leaks per day
Interval -1.4 to -0.4
|
-1.0 leaks per day
Interval -1.8 to -0.2
|
|
Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks
24 Weeks
|
-1.3 leaks per day
Interval -1.8 to -0.8
|
-0.7 leaks per day
Interval -1.1 to -0.2
|
-1.0 leaks per day
Interval -1.5 to -0.6
|
-1.3 leaks per day
Interval -2.2 to -0.5
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
The Modified Manchester Health Questionnaire (MMHQ) includes the 4-item Fecal Incontinence Severity Index (FISI), which measures the severity of liquid, solid, mucus, or gas incontinence that occurs from "2 or more times per day," "once per day," "2 or more times per week," "once a week," to "1-3 times per month." Patient-weighted scores were used to determine severity and scores ranged from 0-61, with higher scores indicating worse fecal incontinence (FI) severity. An FISI score of 0 indicated continence.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=86 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change in Fecal Incontinence Severity Index (FISI) Score
12 Week MMHQ Severity Measures Score
|
-12.4 units on a scale
Interval -19.0 to -5.8
|
-10.6 units on a scale
Interval -17.1 to -4.0
|
-14.4 units on a scale
Interval -20.8 to -7.9
|
-7.8 units on a scale
Interval -18.5 to 2.8
|
|
Change in Fecal Incontinence Severity Index (FISI) Score
24 Week MMHQ Severity Measures Score
|
-19.1 units on a scale
Interval -25.7 to -12.5
|
-15.0 units on a scale
Interval -21.6 to -8.4
|
-19.2 units on a scale
Interval -25.7 to -12.7
|
-20.0 units on a scale
Interval -30.5 to -9.5
|
SECONDARY outcome
Timeframe: 12 and 24 WeeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better), or 3 (a little better).
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=81 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=84 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score
12 Weeks
|
68 Participants
|
57 Participants
|
61 Participants
|
26 Participants
|
|
Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score
24 Weeks
|
67 Participants
|
59 Participants
|
60 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from the manometry form, the outcome variable is computed as the difference in resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at 12 and 24 weeks and resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at baseline
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=84 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks
12 Week Maximum Anal Canal Pressure (Rest)
|
52.6 resting anal canal pressure (mm Hg)
Interval 47.6 to 57.7
|
49.4 resting anal canal pressure (mm Hg)
Interval 44.4 to 54.4
|
51.1 resting anal canal pressure (mm Hg)
Interval 46.4 to 55.9
|
46.3 resting anal canal pressure (mm Hg)
Interval 38.5 to 54.2
|
|
Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks
24 Week Maximum Anal Canal Pressure (Rest)
|
47.7 resting anal canal pressure (mm Hg)
Interval 42.7 to 52.7
|
47.8 resting anal canal pressure (mm Hg)
Interval 42.7 to 52.9
|
45.7 resting anal canal pressure (mm Hg)
Interval 40.8 to 50.5
|
46.5 resting anal canal pressure (mm Hg)
Interval 38.8 to 54.2
|
|
Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks
12 Week Maximum Anal Canal Pressure (Squeeze)
|
83.0 resting anal canal pressure (mm Hg)
Interval 74.4 to 91.6
|
76.3 resting anal canal pressure (mm Hg)
Interval 67.7 to 84.9
|
73.6 resting anal canal pressure (mm Hg)
Interval 65.4 to 81.8
|
73.1 resting anal canal pressure (mm Hg)
Interval 59.5 to 86.6
|
|
Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks
24 Week Maximum Anal Canal Pressure (Squeeze)
|
83.0 resting anal canal pressure (mm Hg)
Interval 74.4 to 91.7
|
74.6 resting anal canal pressure (mm Hg)
Interval 65.9 to 83.4
|
67.1 resting anal canal pressure (mm Hg)
Interval 58.8 to 75.4
|
72.7 resting anal canal pressure (mm Hg)
Interval 59.3 to 86.0
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from the manometry form, the outcome variable is computed as the difference in volume of air (mL) at first sensation for perception of rectal distention at 12 and 24 weeks and volume of air (mL) at first sensation for perception of rectal distention at baseline.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=81 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=84 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks
12 Week Volume of Air at First Sensation
|
19.0 volume of air (mL)
Interval 14.8 to 23.1
|
22.7 volume of air (mL)
Interval 18.5 to 26.9
|
21.6 volume of air (mL)
Interval 17.6 to 25.5
|
25.1 volume of air (mL)
Interval 18.6 to 31.6
|
|
Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks
24 Week Volume of Air at First Sensation
|
20.1 volume of air (mL)
Interval 15.9 to 24.3
|
24.5 volume of air (mL)
Interval 20.3 to 28.7
|
21.6 volume of air (mL)
Interval 17.6 to 25.6
|
23.5 volume of air (mL)
Interval 17.1 to 29.8
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from the manometry form, the outcome variable is computed as the difference in maximum tolerable rectal volume of air (mL) at 12 and 24 weeks and maximum tolerable rectal volume of air (mL) at baseline.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=81 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=84 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks
12 Week Volume of Air at Strong Urge
|
69.3 volume of air (mL)
Interval 61.1 to 77.5
|
66.9 volume of air (mL)
Interval 58.7 to 75.2
|
73.0 volume of air (mL)
Interval 65.1 to 80.8
|
71.8 volume of air (mL)
Interval 58.9 to 84.6
|
|
Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks
24 Week Volume of Air at Strong Urge
|
76.0 volume of air (mL)
Interval 67.8 to 84.2
|
78.4 volume of air (mL)
Interval 70.0 to 86.7
|
77.3 volume of air (mL)
Interval 69.3 to 85.3
|
73.1 volume of air (mL)
Interval 60.4 to 85.7
|
SECONDARY outcome
Timeframe: 12 and 24 weeksPopulation: An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.
Based on data collected from the manometry form, the outcome variable will be computed as the difference in maximum anal pressures during squeeze with the catheter at the high pressure zone (HPZ) at 12 and 24 weeks and maximum anal pressures during squeeze with the catheter at the HPZ at baseline.
Outcome measures
| Measure |
Loperamide - Exercise Plus Biofeedback
n=83 Participants
Participants receive loperamide drug and anal exercises with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=83 Participants
Participants receive placebo drug and anal exercises with biofeedback intervention.
|
Loperamide - Education Only
n=84 Participants
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=41 Participants
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks
12 Week Maximum Anal Canal Pressure (Squeeze)
|
83.0 max. anal canal pressure squeeze (mmHg)
Interval 74.4 to 91.6
|
76.3 max. anal canal pressure squeeze (mmHg)
Interval 67.7 to 84.9
|
73.6 max. anal canal pressure squeeze (mmHg)
Interval 65.4 to 81.8
|
73.1 max. anal canal pressure squeeze (mmHg)
Interval 59.5 to 86.6
|
|
Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks
24 Week Maximum Anal Canal Pressure (Squeeze)
|
83.0 max. anal canal pressure squeeze (mmHg)
Interval 74.4 to 91.7
|
74.6 max. anal canal pressure squeeze (mmHg)
Interval 65.9 to 83.4
|
67.1 max. anal canal pressure squeeze (mmHg)
Interval 58.8 to 75.4
|
72.7 max. anal canal pressure squeeze (mmHg)
Interval 59.3 to 86.0
|
Adverse Events
Loperamide - Exercise Plus Biofeedback
Serious events: 6 serious events
Other events: 71 other events
Deaths: 0 deaths
Placebo - Exercise Plus Biofeedback
Serious events: 5 serious events
Other events: 60 other events
Deaths: 1 deaths
Loperamide - Education Only
Serious events: 10 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo - Education Only
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loperamide - Exercise Plus Biofeedback
n=86 participants at risk
Participants receive loperamide drug and anal exercise with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=84 participants at risk
Participants receive placebo drug and anal exercise with biofeedback intervention.
|
Loperamide - Education Only
n=88 participants at risk
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 participants at risk
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Animal bite
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.2%
1/84 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.2%
1/84 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.2%
1/84 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
General disorders
Death
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.2%
1/84 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Injury, poisoning and procedural complications
Suture related complication
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.3%
2/88 • Number of events 2 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Nervous system disorders
Syncope
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 2 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.2%
1/84 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/86 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Surgical and medical procedures
Medical device removal
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/84 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/88 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
Other adverse events
| Measure |
Loperamide - Exercise Plus Biofeedback
n=86 participants at risk
Participants receive loperamide drug and anal exercise with biofeedback intervention.
|
Placebo - Exercise Plus Biofeedback
n=84 participants at risk
Participants receive placebo drug and anal exercise with biofeedback intervention.
|
Loperamide - Education Only
n=88 participants at risk
Participants receive loperamide drug and educational pamphlet (usual care).
|
Placebo - Education Only
n=42 participants at risk
Participants receive placebo drug and educational pamphlet (usual care).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
4/86 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
7.1%
6/84 • Number of events 6 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.8%
6/88 • Number of events 7 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
4/86 • Number of events 4 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.0%
5/84 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
8.0%
7/88 • Number of events 9 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
11.9%
5/42 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
51.2%
44/86 • Number of events 61 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
22.6%
19/84 • Number of events 22 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
37.5%
33/88 • Number of events 42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
11.9%
5/42 • Number of events 8 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
5/86 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.0%
5/84 • Number of events 6 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.8%
6/88 • Number of events 6 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
16.7%
7/42 • Number of events 8 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.3%
2/86 • Number of events 3 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.0%
5/84 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
1.1%
1/88 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.5%
3/86 • Number of events 3 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
4.8%
4/84 • Number of events 4 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
5.7%
5/88 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
7.1%
3/42 • Number of events 3 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
4/86 • Number of events 4 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
6.0%
5/84 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
3.4%
3/88 • Number of events 3 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
9.3%
8/86 • Number of events 10 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
11.9%
10/84 • Number of events 11 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
10.2%
9/88 • Number of events 14 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
16.7%
7/42 • Number of events 7 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
4/86 • Number of events 4 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
2/84 • Number of events 2 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
8.0%
7/88 • Number of events 7 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
1/42 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/86 • Number of events 1 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
2/84 • Number of events 2 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
5.7%
5/88 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
0.00%
0/42 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
|
Nervous system disorders
Headache
|
5.8%
5/86 • Number of events 6 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
2.4%
2/84 • Number of events 3 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
5.7%
5/88 • Number of events 5 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
4.8%
2/42 • Number of events 2 • 24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place