FREEOAB Study for Overactive Bladder

February 6, 2025 updated by: Avation Medical, Inc.

A Prospective Efficacy Study Comparing FREquency of Use and Efficacy of a Personalized Surgery-free Wearable and Personalized Bladder Modulation System With Objective Confirmation of Nerve Activation for Use in the Home by Subjects With OverActive Bladder Syndrome

This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Pelvic Solutions Center
      • Englewood, Colorado, United States, 80113
        • Colorado Pelvic Floor Consultants
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Women's Health Institute
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Urology of Indiana
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48092
        • Michigan Institute of Urology
    • Texas
      • Webster, Texas, United States, 77598
        • Tranquil Medical Rsearch
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female and 18 years of age or older at the time of enrollment
  2. Willing and capable of giving informed consent
  3. Willing and able to comply with study-related requirements and procedures
  4. Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.
  5. Have been diagnosed or have symptoms of OAB for at least 3 months Page 8 of 30 Version 1.0 dated July 06, 2020 prior to enrollment
  6. Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary
  7. Able to provide clear, thoughtful responses to questions and questionnaires
  8. Able to toilet self and have and maintain personal hygiene
  9. Able to don and doff the bladder modulation garment on their ankle area, replace Gel Pads and use the controller
  10. Have ankle and foot anatomy that allows the garment to fit properly, including having the hook and loop closures close and without excessive gapping and allowing the electrodes to fit firmly on the skin.
  11. Able to sense and tolerate stimulation for the entire 30-minute therapy session
  12. Has detectable EMG signal in response to modulation system stimulation during an investigator supervised screening session
  13. If currently on medications that may affect their OAB symptoms, is on a stable dose (no new, discontinued, or change in dose) of all prescribed medication for at least 4 weeks prior to enrollment
  14. Female subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
  15. Have access to Wi-Fi at least weekly
  16. Are capable of using the tablet-based controlling app

Exclusion Criteria:

  1. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the investigator.
  2. Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body
  3. Have a pacemaker or implanted defibrillator
  4. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)
  5. Current use of a marketed device for treatment of their OAB or incontinence (including but not limited to Interstim®)
  6. Have had Botox treatment for their OAB in the previous 8 months
  7. Current use of transcutaneous electric nerve stimulation (TENS) in pelvic region, back or legs
  8. Had PTNS treatment within 6 months prior to enrollment
  9. Use of investigational drug/device therapy within past 12 weeks
  10. Is concomitantly participating in another clinical study
  11. Had within 6 months of enrollment a significant untreated substance abuse disorder or polysubstance abuse disorder stemming from dependency producing medications, alcohol, and/or illicit drugs
  12. Pregnant or planning to become pregnant within the next 12 weeks
  13. Has scar tissue, metal, or other implant in the target ankle that would interfere with stimulation
  14. Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
  15. Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas.
  16. Has a skin condition in the area of the ankle stimulation location that would preclude them from using surface stimulation
  17. Has been diagnosed with incontinence due to neurogenic bladder
  18. Have failed a third line treatment for their OAB because of lack of effectiveness in the last 2 years (PTNS, Botox, or SNS)
  19. Urge incontinence due to stress predominant mixed urinary incontinence (greater that 60% of the time)
  20. Have polyuria (>2500 cc urine output per day)
  21. Has urinary retention or incomplete bladder emptying
  22. Has symptoms of benign prostatic hyperplasia (BPH -weak stream, straining, hesitancy or intermittency)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 12 Weeks Followed by Optional 12 Month Continuation

Initial 12 Weeks: Patients were instructed to therapy using a wearable closed-loop, continuous sensing tibial nerve stimulation.

Optional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy sessions for the duration of the trial.
Device: Wearable Bladder Modulation System
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders in Voiding (Urinary Frequency) Events
Time Frame: 12 Weeks
The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Responder Rate at 12 Weeks
Time Frame: 12 Weeks
Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.
12 Weeks
Overall Responder Rate at 12 Months
Time Frame: 12 Months
Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.
12 Months
Percentage of Responders in Incontinence (Leak) Events (IE)
Time Frame: 12 Weeks
Percentage of Responders in Incontinence (Leak) Events (IE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total incontinence events per day, or returns to normal (0 events per day), at Week 12.
12 Weeks
Percentage of Responders in Urgency Events (UE)
Time Frame: 12 Weeks
Percentage of Responders in Urgency Events (UE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total urgency events per day, or returns to normal (0 events per day) at Week 12.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avation Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMHOAB2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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