Urinary IncontinenceNCT06085846
Real-World Registry - The Vivally® System
An observational study of Urinary Incontinence and Urinary Urge Incontinence, run by Avation Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Urinary Urge Incontinence
- What is being tested?
- Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to 1 Jul 2043
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Urinary Incontinence, Urinary Urge Incontinence
- Being tested
- Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile Application
- Keywords
- Neuromodulation, Overactive Bladder, Overactive Bladder Syndrome, Wearable, Non-invasive, Mobile Application, Electronic Bladder Diary, Urgency
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile ApplicationDevice
Vivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency.
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Usage
Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.
Measured: Length of Study, on average 20 years
Secondary outcomes (3)
Patient Satisfaction
Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy.
Measured: Length of Study, on average 20 years
Prescribing Trends
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).
Measured: Length of Study, on average 20 years
Patient Compliance
Identify trends in patient compliance in order to optimize the wearable, Vivally® System neuromodulation therapy for participants.
Measured: Length of Study, on average 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start14 Jul 2023
- Primary completion1 Jul 2043 (estimated)
- Study completion1 Jul 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Avation Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085846
- Sponsor's protocol ID
- AMOAB2301
- Status last verified
- May 2024
- First submitted
- 4 Oct 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Registry - The Vivally® System
- ClinicalTrials.gov ID
- NCT06085846
- Acronym / sponsor ID
- AMOAB2301
- Conditions
- Urinary Incontinence, Urinary Urge Incontinence
- Keywords
- Neuromodulation, Overactive Bladder, Overactive Bladder Syndrome, Wearable, Non-invasive, Mobile Application, Electronic Bladder Diary, Urgency
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Avation Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 1 Jul 2043 (estimated)
- Study completion
- 1 Jul 2043 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivally® System Wearable, Non-Invasive Neuromodulation System, and Mobile ApplicationVivally® System Wearable, Non-Invasive Neuromodulation System and Mobile Application to treat patients with the conditions of urinary incontinence and urinary urgency. | Device | – |
Primary outcome
Real-world Usage
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Urinary Urge Incontinence, run by Avation Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Usage (time frame: Length of Study, on average 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.