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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urinary Incontinence; Urinary Urge Incontinence
• Intervention / Treatment: Device: Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application

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

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any person that has been prescribed the Vivally® System by a licensed clinical professional and who provides Informed Consent to allow collection of various data points for future publication.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Usage	Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.	Length of Study, on average 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.	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).	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.	Length of Study, on average 20 years

Collaborators and Investigators

• Sponsor: Avation Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): July 1, 2043
• Study Completion (Estimated): July 1, 2043

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Neuromodulation; Overactive Bladder; Mobile Application; Non-invasive; Urgency; Wearable; Overactive Bladder Syndrome; Electronic Bladder Diary
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: AMOAB2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No