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OpenTrials
Enrolling by Invitation

NCT Number: NCT06085846

Real-World Registry - The Vivally® System

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.

Enrolling by Invitation

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence, Urge Urinary Urge Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avation Medical

Columbus, Ohio, 43201, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Real-world Usage

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: Length of Study, on average 20 years

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

  2. Prescribing Trends

    Time frame: 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).

  3. Patient Compliance

    Time frame: Length of Study, on average 20 years

    Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.

Sponsors and collaborators

Lead sponsor

Avation Medical, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2043
Study completion
2043
First posted
Oct 17, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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