A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period. Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period. During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Rectal Control System.
The American Association of Female Pelvic Medicine
Agoura Hills, California, United States
RECRUITINGThe Ob-Gyn and Incontinence Center
Arcadia, California, United States
RECRUITINGLong Beach Urogynecology
Long Beach, California, United States
Fit Rate
Proportion of patients successfully fit
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
Device Size Distribution
Size distribution of devices among successfully fit patients
Time frame: Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 12 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time frame: 12 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 3 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 6 months
St. Mark's Score (Vaizey)
Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
Time frame: 9 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Florida Urogynecology, LLC
Jacksonville, Florida, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
NOT_YET_RECRUITINGPrinceton Urogynecology
Princeton, New Jersey, United States
RECRUITINGTime frame: 3 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)e
Time frame: 6 months
PGI-I Score
Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
Time frame: 9 months