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PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

RecruitingNA

Sponsor: Axonics, Inc.

Conditions: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)

Interventions: Axonics SNM System INS Model 5101 (R20)

Countries: United States, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test

Locations (6)

Chicago, Illinois, United States
Columbia, Missouri, United States
Bradford, West Yorkshire, United Kingdom
Wakefield, West Yorkshire, United Kingdom
Leeds, United Kingdom
London, United Kingdom