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Clinical Trials in the USA / NCT06085846
Enrolling by invitation Observational

Real-World Registry - The Vivally® System

NCT06085846 · tracked via the Priya Life Science USA tracker
Sponsor
Avation Medical, Inc
Phase
Observational
Started
2023-07-14
Last updated
2024-05-29

Condition(s) studied

Urinary IncontinenceUrinary Urge Incontinence

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Avation Medical Columbus Ohio

Other trials for the same condition

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI Recruiting
RESTORE: An RCT to Evaluate the Efficacy of the Revi System Active, not recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE) Recruiting
Trial of NASHA Dx Urethral Bulking System Starting soon
Clinical Study of External Electrical Stimulation for Male Incontinence Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06085846 on ClinicalTrials.gov ↗ ← All trials in the USA