Trial Outcomes & Findings for The Use of an "Anal-Tape" in Patients With Fecal Incontinence (NCT NCT02989545)
NCT ID: NCT02989545
Last Updated: 2020-04-02
Results Overview
The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 "excellent" to 5 "poor" and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 "extremely so" to 6 "not at all." The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.
COMPLETED
NA
20 participants
2 weeks
2020-04-02
Participant Flow
Participant milestones
| Measure |
Per Sequence
Off treatment first for 14 days Treatment period second for 14 days
|
|---|---|
|
Control Period - no Intervention
STARTED
|
20
|
|
Control Period - no Intervention
COMPLETED
|
20
|
|
Control Period - no Intervention
NOT COMPLETED
|
0
|
|
Treatment Period - Anal Tape Provided
STARTED
|
20
|
|
Treatment Period - Anal Tape Provided
COMPLETED
|
20
|
|
Treatment Period - Anal Tape Provided
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Baseline characteristics by cohort
| Measure |
All Patients
n=20 Participants
2 week period without intervention then 2 week period with anal tape intervention
|
|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThe FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 "excellent" to 5 "poor" and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 "extremely so" to 6 "not at all." The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.
Outcome measures
| Measure |
Off Treatment
n=20 Participants
2 week period without intervention
|
Treatment Period
n=20 Participants
2 week period with intervention - Anal tape
|
|---|---|---|
|
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Lifestyle
|
2.8 score on a scale
Standard Deviation 0.69
|
3.3 score on a scale
Standard Deviation 0.68
|
|
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Coping/Behaivoir
|
1.9 score on a scale
Standard Deviation 0.64
|
2.5 score on a scale
Standard Deviation 0.73
|
|
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Depression/Self-Perception
|
3.1 score on a scale
Standard Deviation 0.75
|
3.5 score on a scale
Standard Deviation 0.74
|
|
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Embarrassment
|
2.13 score on a scale
Standard Deviation 0.67
|
2.65 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.
Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study
Outcome measures
| Measure |
Off Treatment
n=15 Participants
2 week period without intervention
|
Treatment Period
n=15 Participants
2 week period with intervention - Anal tape
|
|---|---|---|
|
A 50% Reduction in the Number of Episodes of FI Per Week
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 weeksThe Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
Outcome measures
| Measure |
Off Treatment
n=20 Participants
2 week period without intervention
|
Treatment Period
n=20 Participants
2 week period with intervention - Anal tape
|
|---|---|---|
|
Mean Wexner Score
|
11.9 score on a scale
Standard Deviation 3.5
|
10.3 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 2 weeksThe Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
Outcome measures
| Measure |
Off Treatment
n=20 Participants
2 week period without intervention
|
Treatment Period
n=20 Participants
2 week period with intervention - Anal tape
|
|---|---|---|
|
Mean Redction in Wexner Scale Compared to Baseline
|
0.6 score on a scale
Standard Deviation 1.7
|
1.95 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.
General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
Outcome measures
| Measure |
Off Treatment
n=17 Participants
2 week period without intervention
|
Treatment Period
2 week period with intervention - Anal tape
|
|---|---|---|
|
General Satisfaction
|
80 mm in VAS scale
Interval 50.0 to 90.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.
Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
Outcome measures
| Measure |
Off Treatment
n=17 Participants
2 week period without intervention
|
Treatment Period
2 week period with intervention - Anal tape
|
|---|---|---|
|
Willingness of the Patient to Continue Using the Anal Tape After the Study.
|
90 mm in VAS scale
Interval 50.0 to 90.0
|
—
|
Adverse Events
Control Period - No Intervention
Treatment Period - Anal Tape Provided
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Period - No Intervention
n=20 participants at risk
Consiting of the first 14 days of the study during which patients were off treatment and baseline and safety data was collected
|
Treatment Period - Anal Tape Provided
n=20 participants at risk
Consiting of the second 14 days of the study (day 15 to 28) during which patients were provided with the "anal tape" device and during this period efficacy and safety data was collected.
|
|---|---|---|
|
Gastrointestinal disorders
Mild difficulty to remove the device
|
0.00%
0/20 • 4 weeks study period
|
15.0%
3/20 • Number of events 3 • 4 weeks study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place