LIBERATEPRO: LIBERATE - PRO: Eclipse™ System Registry
Study Details
Study Description
Brief Summary
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
All LIBERATE (NCT02428595) study participants who complete the 12 month visit will be invited to participate in the LIBERATE-PRO post market registry in an effort to obtain additional long term quality of life and economic data. Subjects will be sent an email with a link to the survey(s) or mailed printed surveys depending on chosen survey delivery option to be completed at 3, 6, 9, and 12 months.Baseline will be defined as the baseline value in the LIBERATE study, prior to the insertion of the Eclipse System.
The St. Mark's (Vaizey) Incontinence Severity Score will be used to assess the severity of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. 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 composite score calculated from these questions reflects the severity of FI and ranges from 0 (complete continence) to 24 (complete incontinence). The change from baseline score will be calculated at each time point. The average change from baseline score, computed as the mean change from baseline across all completed assessments, will be calculated.
The 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.
The FIQOL (Fecal Incontinence Quality of Life Questionnaire will be completed at 12 months. The 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.
The Eclipse Experience feedback (questions related to perceptions of device comfort, satisfaction with usage and features, and impact on daily activities) will be collected at 3, 6, 9, and 12 months.
All outcomes will be summarized descriptively at each time point.
Study Design
Outcome Measures
Primary Outcome Measures
- The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score [3, 6, 9, and 12 months]
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.
Secondary Outcome Measures
- Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score [3, 6, 9, and 12 months]
The 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.
Other Outcome Measures
- The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score [12 months]
The 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has completed the 12-month visit in the LIBERATE study (NCT02428595)
-
Subject has elected to continue to use the Eclipse System outside of the LIBERATE study
-
Subject provides electronic informed consent and HIPAA authorization
Exclusion Criteria:
There are no specific exclusions as this is a data collection registry on a commercially approved product
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pelvalon, Inc. | Sunnyvale | California | United States | 94085 |
Sponsors and Collaborators
- Pelvalon, Inc.
Investigators
- Principal Investigator: Gena Dunivan, MD, Pelvalon Inc.; University of New Mexico
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CA006
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 17 |
| COMPLETED | 11 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 17 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
66.2
(13.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
100%
|
| Male |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
17
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
17
100%
|
| Menopausal Status (Count of Participants) | |
| Pre-menopause |
2
11.8%
|
| Peri-menopause |
0
0%
|
| Post-menopause |
15
88.2%
|
Outcome Measures
| Title | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score |
|---|---|
| Description | 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. |
| Time Frame | 3, 6, 9, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 15 |
| Score at 3 months |
-6.58
(4.96)
|
| Score at 6 months |
-5.47
(5.58)
|
| Score at 9 months |
-7.57
(6.37)
|
| Score at 12 months |
-4.64
(6.14)
|
| Title | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score |
|---|---|
| Description | The 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. |
| Time Frame | 3, 6, 9, and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Subjects at 3 Months | All Subjects at 6 Months | All Subjects at 9 Months | All Subjects at 12 Months |
|---|---|---|---|---|
| Arm/Group Description | 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 3 months into the study. | 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. | 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. | 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. |
| Measure Participants | 12 | 15 | 15 | 13 |
| Very Much Better (1) |
6
35.3%
|
6
NaN
|
7
NaN
|
5
NaN
|
| Much Better (2) |
3
17.6%
|
5
NaN
|
5
NaN
|
5
NaN
|
| A Little Better (3) |
2
11.8%
|
3
NaN
|
3
NaN
|
2
NaN
|
| No Change (4) |
1
5.9%
|
1
NaN
|
0
NaN
|
1
NaN
|
| A Little Worse (5) |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Much Worse (6) |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Very Much Worse (7) |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score |
|---|---|
| Description | The 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. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 11 |
| Change in Lifestyle Subscale score |
.74
(.59)
|
| Change in Coping/Behavior Subscale score |
.87
(.82)
|
| Change in Depression/Self Perception Subscalescore |
.94
(.51)
|
| Change in Embarrassment Subscale score |
.76
(1.03)
|
Adverse Events
| Time Frame | Adverse events were reported for the entirety of the study, for 12 months of patient treatment. Data was collected for a total of 24 months across all patients. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Subjects | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | |
Serious Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Management |
|---|---|
| Organization | Pelvalon |
| Phone | 650-276-0130 |
| steve@pelvalon.com |
- CA006