Fecal Incontinence
Conditions
Keywords
Fecal Incontinence, Sacral Neuromodulation
Brief summary
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Detailed description
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.
Interventions
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.
Sponsors
Axonics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Primary indication of Fecal Incontinence (FI) 3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers
Exclusion criteria
1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance/effectiveness - Improvement in Quality of Life scoring (FI) | 3 months | 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. |
| Performance/effectiveness - Improvement in patient satisfaction scoring (FI) | 3 months | 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". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance/effectiveness - Improvement in Quality of Life scoring (FI) | 12 months | Demonstrate any improvement in CCF-FIS at 1-year 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. |
| Performance/effectiveness - Improvement in patient satisfaction scoring (FI) | 12 months | 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". |
| Adverse event reporting (Safety) | 3 months, 12 months | Device related, procedure-related and all serious adverse events |
Countries
United Kingdom, United States
Contacts
CONTACTCaroline Beaudoint
CONTACTGita Ghadimi, OD
PRINCIPAL_INVESTIGATORKeith Chapple, MD
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed