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New treatment option for Urinary Urge Incontinence (UUI)
Official title PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
ClinicalTrials.gov ID: NCT06789406
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
You likely can't join if
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e...
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may...
- Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral...
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Columbia, Missouri, United States
- Bradford, West Yorkshire, United Kingdom
- Wakefield, West Yorkshire, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Columbia, Missouri, United States; Bradford, West Yorkshire, United Kingdom; Wakefield, West Yorkshire, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.