Evaluation of the Axonics recharge free SNM System for bladder and bowel control
Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
This study is testing a new device to see if it can help people with overactive bladder and bowel control issues feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Axonics, Inc. Industry-sponsored |
| Locations | 14 sites (Waterford, Connecticut and 13 other locations) |
| Trial ID | NCT06186765 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on patients suffering from overactive bladder and fecal incontinence, utilizing the Axonics recharge free sacral neuromodulation system. It is a multicenter, prospective, non-randomized, single-arm study designed to assess the safety and performance of the FDA-approved device. Participants will be monitored for up to one year to evaluate the effectiveness of the treatment in improving their symptoms. The study aims to comply with new European Medical Device Regulations guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with overactive bladder or fecal incontinence who have not responded to conservative treatments.
Not a fit: Patients with significant medical conditions that could interfere with the treatment or evaluation, or those with psychiatric disorders affecting compliance, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with urinary and fecal incontinence.
How similar studies have performed: Previous studies on sacral neuromodulation have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years or older 2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year. Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of 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
Waterford, Connecticut and 13 other locations
- Hartford Healthcare — Waterford, Connecticut, United States (Recruiting)
- Manatee Medical Research Institute — Bradenton, Florida, United States (Active_not_recruiting)
- East Coast Institute of Research — Jacksonville, Florida, United States (Active_not_recruiting)
- Florida Bladder Institute — Naples, Florida, United States (Active_not_recruiting)
- Atrium Health — Macon, Georgia, United States (Active_not_recruiting)
- Minnesota Urology — Coon Rapids, Minnesota, United States (Active_not_recruiting)
- Adult Pediatric Urology & Urogynecology — Omaha, Nebraska, United States (Active_not_recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- The Oregon Clinic — Portland, Oregon, United States (Active_not_recruiting)
- Southern Shores Urogynecology — Myrtle Beach, South Carolina, United States (Recruiting)
- Houston Colon — Houston, Texas, United States (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- Bristol Urological Institute — Bristol, United Kingdom (Recruiting)
- Northern General Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Prof. Bertil Blok, MD, PhD — Erasmus Medical Center
- Study coordinator: Gita Ghadimi, OD
- Email: gita.ghadimi@bsci.com
- Phone: 949-396-6322
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.