Health TrialsbyHealthPanel

Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

ConditionFecal Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAxonics, Inc.

About this trial

Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Primary indication of Fecal Incontinence (FI)

Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers

Disqualifiers

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)

Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements

History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone

A female who is breastfeeding

Trial population

Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Fecal Incontinence1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Performance/effectiveness - Improvement in Quality of Life scoring (FI)

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.

Time frame
12 months
2

Performance/effectiveness - Improvement in Quality of Life scoring (FI)

Demonstrate an improvement in Fecal Incontinence Quality of Life (FIQOL) at 3 months, and 1-year 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
3

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".

Time frame
12 months
4

Adverse event reporting (Safety)

Device related, procedure-related and all serious adverse events

Time frame
3 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axonics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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