Real-World Registry - The Vivally® System

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Avation Medical, Inc.
Study ID
NCT06085846
Status
Enrolling By Invitation

Conditions

  • Urinary Incontinence
  • Urinary Urge Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 14, 2023
Status verified
May 2024
Primary completion
Jul 1, 2043
Completion
Jul 1, 2043

Study Design

Enrollment
5,000 participants (estimated)

Primary Outcome Measure

Real-world Usage [ Time Frame: Length of Study, on average 20 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Avation MedicalColumbusOhio43201-

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By research site
Avation Medical· Columbus, OH

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