FENIX™ Continence Restoration System Registry

Study Overview
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Brief Summary
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The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.

Official Title
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FENIX™ Continence Restoration System Registry

Conditions
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Fecal Incontinence, Faecal Incontinence

Intervention / Treatment
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* Device: FENIX™ Continence Restoration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals being treated with the FENIX™ Continence Restoration System Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry. Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up. Exclusion Criteria: Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy <5 years)
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FENIX participants<br>Individuals being treated with the FENIX™ Continence Restoration System. | Device: FENIX™ Continence Restoration System<br>* The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence. The FENIX™ System is comprised of the following components: FENIX™ System Implant FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed.<br>* Other names: Magnetic anal sphincter augmentation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal incontinence (FI) episodes | Proportion of participants with at least a 50% reduction in FI episodes per week | Evaluate at 6 months and then annually at 12 months through 60 months post implant | 
| Change in fecal incontinence days | Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes | Evaluate at 6 months and then annually at 12 months through 60 months post implant | 
| Adverse events related to the FENIX system | From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately. | assessed up to last follow up [max 60 months] | 
| Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score. | Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales: Lifestyle (10 items) Coping/Behavior (9 items) Depression/Self Perception (7 items) Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a composite or total score but always presented individually. | Evaluate at 6 months and then annually at 12 months through 60 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Anal Sphincter Augmentation, FENIX™ continence restoration system, Magnetic Anal Sphincter