Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
Axonics, Inc.
Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Description
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 years or older 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis) 2. Any psychiatric or p…
Interventions
- DeviceAxonics SNM System INS Model 5101 (R20)
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.
Locations (4)
- University of ChicagoChicago, Illinois
- Bradford Royal InfirmaryBradford, West Yorkshire
- Pinderfields HospitalWakefield, West Yorkshire
- University College London HospitalLondon