Axonics rechargeable sacral neuromodulation system (Model 5101 R20) for overactive bladder
Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
NA · Axonics, Inc. · NCT06789406
This study will test whether the rechargeable Axonics sacral neuromodulation system (Model 5101 R20) stays safe and continues to control symptoms over time in adults with overactive bladder, including urgency incontinence and frequent urination.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Axonics, Inc. (industry) |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Trial ID | NCT06789406 on ClinicalTrials.gov |
What this trial studies
This post-market clinical follow-up enrolls adults with overactive bladder who have received the rechargeable Axonics SNM System INS Model 5101 (R20) to monitor long-term safety, device performance, and clinical benefit. Participants attend scheduled follow-up visits at participating centers where investigators collect safety data, device functioning metrics, and symptom/outcome measures. The protocol excludes patients with major neurological or psychiatric conditions that could confound results and patients previously deemed non-responders to sacral neuromodulation. The multicenter program includes sites in the United States and the United Kingdom and is sponsored by Axonics, Inc.
Who should consider this trial
Good fit: Adults aged 18 or older with primary overactive bladder symptoms (UUI or urinary frequency) who are candidates for or have been implanted with the Axonics Model 5101 R20 and can comply with follow-up visits are ideal participants.
Not a fit: Patients with significant neurological or psychiatric disorders that interfere with device evaluation, or those who previously failed an external SNM trial or were implanted with an SNM device without benefit, are unlikely to receive benefit from participating.
Why it matters
Potential benefit: If successful, the study could confirm durable symptom control and a favorable long-term safety profile for the rechargeable Axonics SNM system, giving patients a reliable, lower-maintenance option for managing OAB.
How similar studies have performed: Sacral neuromodulation is an established therapy for OAB and prior studies and real-world experience with Axonics devices have shown sustained symptom improvement, so this PMCF builds on earlier positive evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 4 other locations
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
- University of Missouri — Columbia, Missouri, United States (RECRUITING)
- Bradford Royal Infirmary — Bradford, West Yorkshire, United Kingdom (RECRUITING)
- Pinderfields Hospital — Wakefield, West Yorkshire, United Kingdom (RECRUITING)
- University College London Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Mahreen Pakzad, MD — University College London Hospitals
- Study coordinator: Anna Selverian
- Email: anna.selverian@bsci.com
- Phone: 714-262-1787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Urge Incontinence, Urinary Frequency, Overactive Bladder