Sacral Neuromodulation for Overactive Bladder
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Axonics, Inc.
Disqualifiers: Neurological conditions, Uncontrolled diabetes, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the Axonics SNM System treatment for overactive bladder?
The Axonics SNM System has been shown to be a safe and effective treatment for overactive bladder, with studies indicating positive outcomes for patients with urinary urgency incontinence. The system is designed to last for at least 15 years, reducing the need for frequent replacements.
12345Is the Axonics Sacral Neuromodulation System safe for humans?
The Axonics Sacral Neuromodulation System is considered safe for treating overactive bladder and urinary urgency incontinence, with studies showing long-term safety and effectiveness. It is a rechargeable device approved by the FDA, designed to last at least 15 years, reducing the need for frequent replacement surgeries.
23567How is the Axonics SNM System treatment different from other treatments for overactive bladder?
The Axonics SNM System is unique because it is the first rechargeable sacral neuromodulation device, designed to last at least 15 years, reducing the need for frequent replacement surgeries compared to non-rechargeable systems.
23468Eligibility Criteria
This trial is for men over 18 with an overactive bladder due to conditions like prostate cancer, benign prostatic hyperplasia, or after treatments like prostatectomy. Participants must have urinary urgency incontinence and be willing to attend follow-up assessments for a year.Inclusion Criteria
Key
I am 18 years old or older.
My main diagnosis is Urinary Urgency Incontinence.
Participant Groups
The Axonics SNM System, a device designed to treat overactive bladder symptoms in men, is being tested. The study will monitor the effectiveness of this system post-market in real-world clinical settings.
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Clinical outcomes with use of Axonics SNM system for the male OAB population.
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:
El Camino HealthMountain View, CA
Manatee Medical Research InstituteBradenton, FL
Potomac UrologyWoodbridge, VA
WK Clinical ResearchShreveport, LA
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Who is running the clinical trial?
Axonics, Inc.Lead Sponsor
References
Review of the rechargeable sacral neuromodulation system to treat refractory overactive bladder. [2021]Overactive bladder is a medical condition that requires management. If left untreated, it may severely affect quality of life. When first- and second-line treatments fail, sacral neuromodulation can be a safe and effective option for patients with refractory overactive bladder. This article reviews the rechargeable sacral neuromodulation (Axonics).
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.
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.
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.
Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. [2020]Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes.
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.
[Sacral neuromodulation for refractory overactive bladder]. [2019]Sacral neuromodulation (SNM) is a minimally invasive, established treatment modality for overactive bladder (OAB) as well as for other pelvic functional disorders, such as non-obstructive urinary retention and fecal incontinence. A pacemaker implanted in the upper buttocks delivers mild electrical pulses to the sacral nerves thereby modulating pathological afferent signals from pelvic end organs. The current article conveys the current knowledge on the indications, contraindications, mechanism of action, implantation technique, efficacy and complications of SNM for the treatment refractory OAB.