Clinical trial NCT06085846: Real-World Registry - The Vivally® System
Official title: Real-World Registry - The Vivally® System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Urinary Incontinence
Urinary Urge Incontinence
Keywords: Neuromodulation
Overactive Bladder
Overactive Bladder Syndrome
Wearable
Non-invasive
Mobile Application
Electronic Bladder Diary
Urgency
Lead sponsor: Avation Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Real-world Usage
timeFrame: Length of Study, on average 20 years
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Length of Study, on average 20 years
measure: Prescribing Trends
timeFrame: Length of Study, on average 20 years
measure: Patient Compliance
timeFrame: Length of Study, on average 20 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Avation Medical
state: Ohio
Study officials:
References: