Trial Outcomes & Findings for LIBERATE - PRO: Eclipse™ System Registry (NCT NCT03028636)
NCT ID: NCT03028636
Last Updated: 2020-01-28
Results Overview
The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.
Recruitment status
COMPLETED
Target enrollment
17 participants
Primary outcome timeframe
3, 6, 9, and 12 months
Results posted on
2020-01-28
Participant Flow
Participant milestones
| Measure |
All Subjects
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LIBERATE - PRO: Eclipse™ System Registry
Baseline characteristics by cohort
| Measure |
All Subjects
n=17 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Surveys were completed at 3, 6, 9, and 12 months during the study.
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|---|---|
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Age, Continuous
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66.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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17 participants
n=5 Participants
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Menopausal Status
Pre-menopause
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2 Participants
n=5 Participants
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Menopausal Status
Peri-menopause
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0 Participants
n=5 Participants
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Menopausal Status
Post-menopause
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15 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 3, 6, 9, and 12 monthsPopulation: The number analyzed for each time point is the number of participants who provided a survey. Some participants provided surveys for some but not all time points.
The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.
Outcome measures
| Measure |
All Subjects
n=15 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Surveys were completed at 3, 6, 9, and 12 months during the study.
|
All Subjects at 6 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 6 months into the study.
|
All Subjects at 9 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 9 months into the study.
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All Subjects at 12 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 12 months into the study.
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|---|---|---|---|---|
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The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
Score at 3 months
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-6.58 Score on a Scale
Standard Deviation 4.96
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—
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—
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—
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The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
Score at 6 months
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-5.47 Score on a Scale
Standard Deviation 5.58
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—
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—
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—
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The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
Score at 9 months
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-7.57 Score on a Scale
Standard Deviation 6.37
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—
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—
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—
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The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
Score at 12 months
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-4.64 Score on a Scale
Standard Deviation 6.14
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—
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—
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—
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SECONDARY outcome
Timeframe: 3, 6, 9, and 12 monthsThe Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.
Outcome measures
| Measure |
All Subjects
n=12 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Surveys were completed at 3, 6, 9, and 12 months during the study.
|
All Subjects at 6 Months
n=15 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 6 months into the study.
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All Subjects at 9 Months
n=15 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 9 months into the study.
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All Subjects at 12 Months
n=13 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 12 months into the study.
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|---|---|---|---|---|
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
Very Much Better (1)
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6 Participants
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6 Participants
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7 Participants
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5 Participants
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
Much Better (2)
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3 Participants
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5 Participants
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5 Participants
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5 Participants
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
A Little Better (3)
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2 Participants
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3 Participants
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3 Participants
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2 Participants
|
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
No Change (4)
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1 Participants
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1 Participants
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0 Participants
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1 Participants
|
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
A Little Worse (5)
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0 Participants
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0 Participants
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0 Participants
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0 Participants
|
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
Much Worse (6)
|
0 Participants
|
0 Participants
|
0 Participants
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0 Participants
|
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Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
Very Much Worse (7)
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsThe Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.
Outcome measures
| Measure |
All Subjects
n=11 Participants
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Surveys were completed at 3, 6, 9, and 12 months during the study.
|
All Subjects at 6 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 6 months into the study.
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All Subjects at 9 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 9 months into the study.
|
All Subjects at 12 Months
Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
This arm represents patients who completed surveys 12 months into the study.
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|---|---|---|---|---|
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The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
Change in Lifestyle Subscale score
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.74 Score on a scale
Standard Deviation .59
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—
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—
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—
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The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
Change in Coping/Behavior Subscale score
|
.87 Score on a scale
Standard Deviation .82
|
—
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—
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—
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The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
Change in Depression/Self Perception Subscalescore
|
.94 Score on a scale
Standard Deviation .51
|
—
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—
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—
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The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
Change in Embarrassment Subscale score
|
.76 Score on a scale
Standard Deviation 1.03
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—
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—
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—
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Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60