Real-World Registry - The Vivally® System

NCT06085846 | Enrolling By Invitation FDA Device

• 1 other identifier: AMOAB2301
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence; Urinary Urge Incontinence

Keywords

Neuromodulation; Overactive Bladder; Overactive Bladder Syndrome; Wearable; Non-invasive; Mobile Application; Electronic Bladder Diary; Urgency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Satisfaction

  Length of Study, on average 20 years

• Prescribing Trends

  Length of Study, on average 20 years

• Patient Compliance

  Length of Study, on average 20 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avation Medical, Inc.: lead

Study Sites (1)

Avation Medical

Columbus, Ohio, 43201, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 17, 2023
• Study Start: July 14, 2023
• Primary Completion (Estimated): July 1, 2043
• Study Completion (Estimated): July 1, 2043
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)