Real-World Registry - The Vivally® System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence, Urinary Urge Incontinence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Device 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.
Primary outcome measures
- Real-world Usage [Time frame: Length of Study, on average 20 years]
Secondary outcome measures (3)
- Patient Satisfaction [Time frame: Length of Study, on average 20 years]
- Prescribing Trends [Time frame: Length of Study, on average 20 years]
- Patient Compliance [Time frame: Length of Study, on average 20 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Avation Medical — Columbus
Identifiers
NCT: NCT06085846 · AMOAB2301