Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application
Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application: Vivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency.
Study summary
This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to:
Therapy compliance and stimulation metrics
Diary entries provided by patients
Various questionnaires
Participants have the option to opt out of allowing their data to be part of any publication at any time.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
To be eligible for the Real-World Registry Study, Participants must satisfy all of the following criteria:
* Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional
* Have provided informed consent to have their data included in publications associated with this study
Exclusion Criteria:
While it is up to the discretion of the clinician to prescribe the Vivally® System for a specific patient, the Vivally® System is contraindicated for use on patients who have the following history or conditions:
* Patients with pacemakers of implanted defibrillators
* Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function
* This product is not intended for intra-cardiac or trans-thoracic use
Additional contraindications, warnings and precautions are listed in the User Guide.
Primary outcome measure(s)
Real-world Usage — Length of Study, on average 20 years Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.