Real-World Registry - The Vivally® System

Launched by AVATION MEDICAL, INC. · Oct 10, 2023

Keywords

ClinConnect Summary

This is a Real-World Registry study led by Avation Medical to learn how the Vivally® System (a wearable, non-invasive device plus a mobile app) is used in everyday life to treat urinary incontinence and urgency. Researchers will collect information on how people use the therapy, dosing settings, and how it affects daily life and quality of life. They’ll also gather patient feedback and diary entries to identify patterns that could help improve the device and its use. The study is observational and prospective and plans to follow participants for about 20 years, aiming to enroll up to 5,000 people.

Who can join: Adults 18 and older who have been prescribed the Vivally System by a licensed clinician and who agree to let their data be used in publications. Exclusions include people with certain implanted heart devices (like pacemakers or defibrillators) or nerve damage that could affect how the therapy works, or situations where use isn’t advised by the User Guide. Participants will use the Vivally System and may provide diary entries and answer questionnaires through a HIPAA-compliant cloud database. They can opt out of having their data published at any time. The study is sponsored by Avation Medical and is currently enrolling by invitation.

Gender

ALL

Eligibility criteria

• 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.