Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03028636
Study type Observational [Patient Registry]
Source Pelvalon, Inc.
Contact
Status Completed
Phase
Start date September 19, 2016
Completion date February 27, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03825575 - Sacral Neuromodulation as Treatment for Fecal Incontinence N/A
Completed NCT00605826 - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence N/A
Withdrawn NCT02208258 - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool. N/A
Completed NCT01939821 - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes N/A
Completed NCT01957969 - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Recruiting NCT00530933 - Tibial Nerve Stimulation for Faecal Incontinence N/A
Withdrawn NCT00522691 - Efficacy of Sacral Nerve Stimulation Before Definitive Implantation N/A
Completed NCT00565136 - Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms Phase 1/Phase 2
Completed NCT00677508 - Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Completed NCT05032534 - Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence N/A
Completed NCT05058326 - Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Completed NCT03746834 - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation Phase 4
Completed NCT00124904 - Biofeedback for Fecal Incontinence N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1
Completed NCT05621629 - Management of FI After Surgery of ARM
Withdrawn NCT04138602 - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence N/A
Completed NCT03252951 - Physical Therapy for Anal Incontinence N/A
Completed NCT04478799 - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience N/A
Withdrawn NCT00307476 - Comparison of Rectal Trumpet and Standard Care N/A