LIBERATE - PRO: Eclipse™ System Registry (LIBERATEPRO)

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

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Bowel Dysfunction; Bowel Incontinence; Accidental Bowel Leakage

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • California
    • Sunnyvale, California, United States, 94085
      • Pelvalon, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 9, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Pelvalon, Inc.
• Investigators: Principal Investigator: Gena Dunivan, MD, Pelvalon Inc.; University of New Mexico

Publications and helpful links

Helpful Links

• LIBERATE Clinical Trials.gov listing
• Pelvalon, Eclipse manufacturer and Study Sponsor, website

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: medical device; women's health; incontinence; fecal incontinence; accidental bowel leakage; pessary; pump; bowel control; vaginal insert; bowel continence
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Intestinal Diseases; Fecal Incontinence
• Other Study ID Numbers: CA006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No