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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FENIX participants | Individuals being treated with the FENIX™ Continence Restoration System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FENIX™ Continence Restoration System | Device | 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:
|
| 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:
| Evaluate at 6 months and then annually at 12 months through 60 months post implant |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Nantes | Nantes | France | ||||
| Kliniken Essen-Mitte |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
|
| Essen |
| Germany |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |