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

Axonics, Inc. · NCT06789406

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
55
US sites recruiting
2
Study start
September 18, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Axonics SNM System INS Model 5101 (R20)

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Chicago

    Chicago, IL 60637

    Site contact: Rowena Shi

  • University of Missouri

    Columbia, MO 65211

    Site contact: Kaycee Mackanos

Study contacts (from the official record)

  • Caroline Beaudoint · +32479904163 · Caroline.Beaudoint@bsci.com
  • Erum Shaikh · 657-626-4310 · Erum.Shaikh@bsci.com
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PMCF Study of the Axonics SNM System Model 5101 (R20) for the… (NCT06789406) | Bored Studies