Fecal IncontinenceLIBERATEPRONCT03028636
LIBERATE - PRO: Eclipse™ System Registry
An observational study of Fecal Incontinence and Bowel Dysfunction, run by Pelvalon, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2016to 27 Feb 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There are no specific exclusions as this is a data collection registry on a commercially approved product
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- fecal incontinence, bowel control, accidental bowel leakage, medical device, women's health, vaginal insert, pessary, incontinence, bowel continence, pump
- Medical subject headings
- Fecal Incontinence, Intestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, 9, and 12 months
Secondary outcomes (1)
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.
Measured: 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start19 Sep 2016
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pelvalon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gena Dunivan, MD, Principal investigator, Pelvalon Inc.; University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028636
- Sponsor's protocol ID
- CA006
- Acronym
- LIBERATEPRO
- Status last verified
- Jan 2020
- First submitted
- 9 Dec 2016
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03028636
- Acronym / sponsor ID
- LIBERATEPRO / CA006
- Keywords
- fecal incontinence, bowel control, accidental bowel leakage, medical device, women's health, vaginal insert, pessary, incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pelvalon, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusions as this is a data collection registry on a commercially approved product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
Time frame: 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.
1 secondary outcome
Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
Time frame: 3, 6, 9, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- LIBERATE Clinical Trials.gov listingLink provided by the sponsor.
- Pelvalon, Eclipse manufacturer and Study Sponsor, websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gena Dunivan, MD principal investigator
Pelvalon Inc.; University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence and Bowel Dysfunction, run by Pelvalon, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score (time frame: 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.