Axonics SNM System for Overactive Bladder and Fecal Incontinence
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Axonics, Inc.
Disqualifiers: Neurological conditions, Psychiatric disorders, SNM non-responder, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345How 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.
12346Eligibility Criteria
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
You are able to sign a consent form and agree to attend all required check-ups and evaluations for up to 1 year.
I have overactive bladder or fecal incontinence and treatments haven't worked for me.
I am 18 years old or older.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Axonics recharge free SNM System for overactive bladder and/or fecal incontinence
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Participant Groups
The study is testing the Axonics SNM System, a device designed for people with OAB or FI. It's a single-arm evaluation, meaning all participants receive the same treatment without comparison to another group or placebo.
1Treatment groups
Experimental Treatment
Group I: Single Arm - product does not have Communauté Européenne (CE) Mark in EuropeExperimental Treatment1 Intervention
Observational
Axonics SNM System is already approved in United States, Canada, Australia, European Union for the following indications:
🇺🇸 Approved in United States as Axonics SNM System for:
- Urinary retention
- Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
- Chronic fecal incontinence
🇨🇦 Approved in Canada as Axonics SNM System for:
- Urinary retention
- Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
- Chronic fecal incontinence
🇦🇺 Approved in Australia as Axonics SNM System for:
- Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
🇪🇺 Approved in European Union as Axonics SNM System for:
- Overactive bladder symptoms including urinary urge incontinence and urgency-frequency
- Faecal incontinence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Coast Institute of ResearchJacksonville, FL
The Oregon ClinicPortland, OR
Manatee Medical Research InstituteBradenton, FL
Florida Bladder InstituteNaples, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Axonics, Inc.Lead Sponsor
References
One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence. [2020]Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented.
Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. [2021]Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.
Satisfaction with a rechargeable sacral neuromodulation system-A secondary analysis of the ARTISAN-SNM study. [2021]To describe factors associated with satisfaction with the Axonics sacral neuromodulation (SNM) System at 1 year.
Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence. [2021]Introduction: Overactive bladder and urge urinary incontinence affect millions of women and men and results in billions of dollars in health-care expenses. First- and second-line therapy includes behavioral modifications and/or pharmacotherapies however, many patients' symptoms remain or progress on these treatments. There has been concern regarding the detrimental side effects of the most widely prescribed medications for these bladder symptom management.Areas covered: As a result, there has been increased interest in continuous sacral neuromodulation, an FDA approved therapy for refractory urinary urgency and urge urinary incontinence. In this article, we specifically review current research on the efficacy and patient/provider satisfaction and safety profile of the Axonics® System. In addition, we address the current state of sacral neuromodulation and potential future direction and applicability.Expert opinion: The Axonics® system is a safe effective device for the treatment of overactive bladder and urinary urge incontinence. Additionally, it affords patient's the convenience of a rechargeable, compact, MRI safe system. It should be noted that the rechargeable system, while allowing for approximately 15 years of battery and lead life, may have its challenges in terms of charge burden. Furthermore, this system is easily adapted for experienced implanters of sacral neuromodulating devices.
Sacral neuromodulation system for treating refractory overactive bladder. [2021]Sacral neuromodulation (SNM) is a therapy system used to improve bladder function, including in people with overactive bladder (OAB). It is safe and can improve quality of life. SNM helps improve symptoms through direct modulation of nerve activity; it involves electrically stimulating the sacral nerves that carry signals between the pelvic floor, spinal cord and the brain and is thought to normalise neural communication between the bladder and brain. If patients with OAB do not respond to non-surgical and conservative options, minimally invasive procedures can be offered, including SNM. SNM is performed in two stages: the trial phase, to assess whether it would be effective in the long term; and permanent implantation. This year, the National Institute for Health and Care Excellence (NICE) released guidance on the Axonics SNM System® for treating refractory OAB. The Axonics System is rechargeable and lasts at least 15 years, minimising the need for repeat surgery. NICE suggests the Axonics System may have cost advantages for the NHS. Having more than one SNM therapy option available increases options for patients, offering them a choice of handsets and rechargeable versus non-rechargeable implants. Three case studies illustrate how the system works in practice.
Initial experience using the Axonics sacral neuromodulation system in patients with multiple sclerosis. [2022]Sacral neuromodulation (SNM) is third-line therapy approved for urge urinary incontinence (UUI) and urgency, and nonobstructive urinary retention. Multiple sclerosis (MS) patients often suffer from neurogenic lower urinary tract dysfunction (NLUTD). The utility of SNM in the MS population is limited by magnetic resonance imaging (MRI) incompatibility as routine MRIs to evaluate for disease progression are required. The Axonics System is the first Food and Drug Administration-approved SNM device that is 1.5/3 T full-body MRI-conditionally safe. This study seeks to investigate the symptomatic improvement in MS patients after implantation of the Axonics System.