Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
Study Type
OBSERVATIONAL
Enrollment
55
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Short-term FI improvement demonstrated by Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Time frame: 3 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
Short-term FI improvement demonstrated by Participant Satisfaction with Treatment and Charging Questionnaire. Participants will indicate satisfaction with SNM therapy for treatment of their FI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied".
Time frame: 3 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate any improvement in CCF-FIS at 1-year and 2-years post-implant compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Time frame: 12 months, 24 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate an improvement in Fecal Incontinence Quality of Life (FIQOL) at 3 months, 1-year, and 2-years post-implant compared to baseline. Fecal Incontinence Quality of Life (FIQOL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Time frame: 3 months, 12 months, 24 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
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Participant Satisfaction with Treatment and Charging Questionnaire at 1-year post-implant compared to baseline. Participants will indicate satisfaction with SNM therapy for treatment of their FI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied".
Time frame: 12 months
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 3 months, 12 months, 24 months