Accidental Bowel Leakage, Bowel Dysfunction, Bowel Incontinence, Fecal Incontinence
Conditions
Keywords
fecal incontinence, bowel control, accidental bowel leakage, medical device, women's health, vaginal insert, pessary, incontinence, bowel continence, pump
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.
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.
Interventions
None listed
Sponsors
Pelvalon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Surveys were completed at 3, 6, 9, and 12 months during the study. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 13.2 |
| Menopausal Status Peri-menopause | 0 Participants |
| Menopausal Status Post-menopause | 15 Participants |
| Menopausal Status Pre-menopause | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Subjects | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | Score at 3 months | -6.58 Score on a Scale | Standard Deviation 4.96 |
| All Subjects | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | Score at 6 months | -5.47 Score on a Scale | Standard Deviation 5.58 |
| All Subjects | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | Score at 9 months | -7.57 Score on a Scale | Standard Deviation 6.37 |
| All Subjects | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | Score at 12 months | -4.64 Score on a Scale | Standard Deviation 6.14 |
Secondary
Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Better (1) | 6 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Worse (6) | 0 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Worse (5) | 0 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Better (2) | 3 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Worse (7) | 0 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Better (3) | 2 Participants |
| All Subjects | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | No Change (4) | 1 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Worse (6) | 0 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | No Change (4) | 1 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Better (3) | 3 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Worse (5) | 0 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Worse (7) | 0 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Better (2) | 5 Participants |
| All Subjects at 6 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Better (1) | 6 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | No Change (4) | 0 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Better (1) | 7 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Better (2) | 5 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Better (3) | 3 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Worse (5) | 0 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Worse (6) | 0 Participants |
| All Subjects at 9 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Worse (7) | 0 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Better (3) | 2 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Worse (7) | 0 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Worse (6) | 0 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Much Better (2) | 5 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | Very Much Better (1) | 5 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | A Little Worse (5) | 0 Participants |
| All Subjects at 12 Months | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | No Change (4) | 1 Participants |
Other Pre-specified
The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Subjects | The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score | Change in Lifestyle Subscale score | .74 Score on a scale | Standard Deviation 0.59 |
| All Subjects | 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 0.82 |
| All Subjects | 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 0.51 |
| All Subjects | 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 |