Real-World Registry - The Vivally® System

Study Overview
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Brief Summary
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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.

Detailed Description
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Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System. Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy Identify trends in dosing, compliance, and therapy parameters in order to optimize the wearable, Vivally® System neuromodulation therapy for participants

Official Title
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Real-World Registry - The Vivally® System

Conditions
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Urinary Incontinence, Urinary Urge Incontinence

Intervention / Treatment
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* Device: Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world Usage | Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System. | Length of Study, on average 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy. | Length of Study, on average 20 years | 
| Prescribing Trends | Identify trends in dosing in order to optimize the wearable, Vivally® System neuromodulation therapy for prescribers. Dosing consists of therapy pulse width parameters (μs) and therapy schedule (sessions completed per week). | Length of Study, on average 20 years | 
| Patient Compliance | Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants. | Length of Study, on average 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, Overactive Bladder, Overactive Bladder Syndrome, Wearable, Non-invasive, Mobile Application, Electronic Bladder Diary, Urgency