PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Recruiting
N/A
Interventional Study
Urinary Urge Incontinence (UUI)
Urinary Frequency (UF)
Overactive Bladder (OAB)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- Axonics, Inc. · Industry
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About This Trial
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.
Trial Locations
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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 …
Contacts