Clinical trial NCT03028636: LIBERATE - PRO: Eclipse™ System Registry
Official title: LIBERATE - PRO: An Extended Use Registry to Further Develop Understanding of the Long Term Use of the Eclipse™ System for Fecal Incontinence in Women Via Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Bowel Dysfunction
Bowel Incontinence
Accidental Bowel Leakage
Keywords: fecal incontinence
bowel control
accidental bowel leakage
medical device
women's health
vaginal insert
pessary
incontinence
bowel continence
pump
Lead sponsor: Pelvalon, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 17
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects exiting the LIBERATE study who are continuing to use the Eclipse System. Since all of the women in the prior LIBERATE study had to be over the age of 19 to participate in it, this means that all subjects in the registry will be over the age of 19 by default. For information about the LIBERATE study including inclusion/exclusion criteria please see NCT02428595.

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.

Eligibility 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

Primary outcomes:
measure: The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
timeFrame: 3, 6, 9, and 12 months
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
timeFrame: 3, 6, 9, and 12 months
Other outcomes:
measure: The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
timeFrame: 12 months
Locations:
city: Sunnyvale
country: United States
facility: Pelvalon, Inc.
state: California
Study officials:
affiliation: Pelvalon Inc.; University of New Mexico
name: Gena Dunivan, MD
role: PRINCIPAL_INVESTIGATOR
References: