Urinary Incontinence, Urinary Urge Incontinence
Conditions
Keywords
Neuromodulation, Overactive Bladder, Overactive Bladder Syndrome, Wearable, Non-invasive, Mobile Application, Electronic Bladder Diary, Urgency
Brief 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.
Detailed description
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
Interventions
DEVICEVivally® 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.
Sponsors
Avation Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Length of Study, on average 20 years | Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy. |
| Prescribing Trends | Length of Study, on average 20 years | 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). |
| Patient Compliance | Length of Study, on average 20 years | Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants. |
Countries
United States
Outcome results
None listed