Real-World Registry - The Vivally® System

N/AEnrolling By InvitationNCT06085846

Avation Medical, Inc.5,000 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Urinary Incontinence Urinary Urge Incontinence

Interventions

Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile ApplicationDEVICE

Vivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Avation Medical

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Real-world Usage

Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.

Time frame: Length of Study, on average 20 years

Secondary Outcomes

Patient Satisfaction

Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.

Time frame: 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).

Time frame: 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.

Time frame: Length of Study, on average 20 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.