Real-World Registry - The Vivally® System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-14

Study Completion Date

2043-07-01

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.

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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

Conditions

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Urinary Incontinence Urinary Urge Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No