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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Incontinence | Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axonics SNM System INS Model 5101 (R20) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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". | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Beaudoint | Contact | +32 (0) 479 90.41.63 | caroline.beaudoint@bsci.com | |
| Gita Ghadimi, OD | Contact | 1-949-981-4366 | gita.ghadimi@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Keith Chapple, MD | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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. | 3 months, 12 months, 24 months |
| Performance/effectiveness - Improvement in patient satisfaction scoring (FI) | 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". | 12 months |
| Adverse event reporting (Safety) | Device related, procedure-related and all serious adverse events | 3 months, 12 months, 24 months |
| Houston Colon | Houston | Texas | 77030 | United States |
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