Axonics SNM System for Overactive Bladder and Fecal Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the Axonics SNM System treatment different from other treatments for overactive bladder and fecal incontinence?
The Axonics SNM System is unique because it is a rechargeable sacral neuromodulation device designed to last at least 15 years, reducing the need for frequent replacements compared to non-rechargeable systems. It is also the first FDA-approved SNM device that is MRI-safe, making it suitable for patients who require regular MRI scans.12345
What data supports the effectiveness of the Axonics SNM System treatment for overactive bladder and fecal incontinence?
The Axonics SNM System has shown effectiveness in treating urinary urgency incontinence, a condition related to overactive bladder, with positive outcomes reported in studies over one and two years. This system is designed to last at least 15 years, reducing the need for frequent surgeries, and is considered safe and effective for improving bladder function by stimulating the sacral nerves.12346
Who Is on the Research Team?
Prof. Bertil Blok, MD, PhD
Principal Investigator
Erasmus Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with overactive bladder (OAB) or fecal incontinence (FI) who haven't had success with standard treatments. Participants must be able to give informed consent and commit to follow-up assessments for up to a year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Axonics recharge free SNM System for overactive bladder and/or fecal incontinence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axonics SNM System
Axonics SNM System is already approved in United States, Canada, European Union for the following indications:
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Who Is Running the Clinical Trial?
Axonics, Inc.
Lead Sponsor