Real-World Registry - The Vivally® System

• Conditions: Urinary Incontinence; Urinary Urge Incontinence

• Registration Number: NCT06085846
• Lead Sponsor: Avation Medical, Inc.

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.

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 Timeline

• Study Start: 2023-07-14
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2043-07-01
• Study Completion: 2043-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Prescribing Trends	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).
Patient Satisfaction	Length of Study, on average 20 years	Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.
Patient Compliance	Length of Study, on average 20 years	Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.

Trial Locations

Locations (1)

Avation Medical; 🇺🇸 Columbus, Ohio, United States