PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axonics SNM System INS Model 5101 (R20).
- Who it may be relevant to
- Registry conditions: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
Overview
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.
Detailed 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.
Interventions
- Device Axonics 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.
Primary outcome measures
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) [Time frame: 3 months]
- Adverse event reporting (Safety) [Time frame: 3 months]
Secondary outcome measures (2)
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) [Time frame: 12 months]
- Performance/Effectiveness - Improvement in Qualify of Life scoring (FI) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Exclusion criteria
- 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)
- 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
- 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)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 3 centers
- Bradford Royal Infirmary — Bradford
- Pinderfields Hospital — Wakefield
- University College London Hospital — London
United States · 2 centers
- University of Chicago — Chicago
- University of Missouri — Columbia
Identifiers
NCT: NCT06789406 · 105-0104