Overactive BladderNCT04547920

FREEOAB Study for Overactive Bladder

A study testing Wearable Bladder Modulation System in people with Overactive Bladder and Urinary Frequency, run by Avation Medical, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge
What is being tested?: Wearable Bladder Modulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 9 sitesUnited States
Study dates: 11 Jan 2021to 15 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Male or female and 18 years of age or older at the time of enrollment
Willing and capable of giving informed consent
Willing and able to comply with study-related requirements and procedures
Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.
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
Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary

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Able to provide clear, thoughtful responses to questions and questionnaires
Able to toilet self and have and maintain personal hygiene
Able to don and doff the bladder modulation garment on their ankle area, replace Gel Pads and use the controller
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.
Able to sense and tolerate stimulation for the entire 30-minute therapy session
Has detectable EMG signal in response to modulation system stimulation during an investigator supervised screening session
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
Female subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
Have access to Wi-Fi at least weekly
Are capable of using the tablet-based controlling app

Who cannot join

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.
Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body
Have a pacemaker or implanted defibrillator
Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)
Current use of a marketed device for treatment of their OAB or incontinence (including but not limited to Interstim®)
Have had Botox treatment for their OAB in the previous 8 months

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Current use of transcutaneous electric nerve stimulation (TENS) in pelvic region, back or legs
Had PTNS treatment within 6 months prior to enrollment
Use of investigational drug/device therapy within past 12 weeks
Is concomitantly participating in another clinical study
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
Pregnant or planning to become pregnant within the next 12 weeks
Has scar tissue, metal, or other implant in the target ankle that would interfere with stimulation
Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas.
Has a skin condition in the area of the ankle stimulation location that would preclude them from using surface stimulation
Has been diagnosed with incontinence due to neurogenic bladder
Have failed a third line treatment for their OAB because of lack of effectiveness in the last 2 years (PTNS, Botox, or SNS)
Urge incontinence due to stress predominant mixed urinary incontinence (greater that 60% of the time)
Have polyuria (>2500 cc urine output per day)
Has urinary retention or incomplete bladder emptying
Has symptoms of benign prostatic hyperplasia (BPH -weak stream, straining, hesitancy or intermittency)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

Official title: 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

Conditions: Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
Being tested: Wearable Bladder Modulation System
Keywords: Neuromodulation, Closed-Loop Neuromodulation, Wearable Neuromodulation, Tibial Nerve Stimulation, Continuous Sensing, Automatic Adjustment
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wearable Bladder Modulation SystemDevice
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

Study groups in NCT04547920
Study group	Role	What they receive
12 Weeks Followed by Optional 12 Month Continuation	Experimental	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. Receives: Device: Wearable Bladder Modulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Responders in Voiding (Urinary Frequency) Events
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.
Measured: 12 Weeks

Secondary outcomes (4)

Percentage of Responders in Incontinence (Leak) Events (IE)
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.
Measured: 12 Weeks
Percentage of Responders in Urgency Events (UE)
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.
Measured: 12 Weeks
Overall Responder Rate at 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.
Measured: 12 Weeks
Overall Responder Rate at 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.
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202115 Jun 2023

First posted14 Sep 2020
Study start11 Jan 2021
Primary completion8 Oct 2021
Study completion15 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04547920
Sponsor's protocol ID: AMHOAB2001
Status last verified: Feb 2025
First submitted: 8 Sep 2020
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04547920
Acronym / sponsor ID: AMHOAB2001
Conditions: Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
Keywords: Neuromodulation, Closed-Loop Neuromodulation, Wearable Neuromodulation, Tibial Nerve Stimulation, Continuous Sensing, Automatic Adjustment
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Avation Medical, Inc.Industry (pharma, biotech, devices)
Study start: 11 Jan 2021 (actual)
Primary completion: 8 Oct 2021 (actual)
Study completion: 15 Jun 2023 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
12 Weeks Followed by Optional 12 Month Continuation	Experimental	Device: Wearable Bladder Modulation SystemInitial 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male or female and 18 years of age or older at the time of enrollment
Willing and capable of giving informed consent
Willing and able to comply with study-related requirements and procedures
Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.
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

Key exclusion criteria (22 listed)

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.
Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body
Have a pacemaker or implanted defibrillator
Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)
Current use of a marketed device for treatment of their OAB or incontinence (including but not limited to Interstim®)

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
Wearable Bladder Modulation SystemWearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device	Device	12 Weeks Followed by Optional 12 Month Continuation

Primary outcome

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.

4 secondary outcomes

Percentage of Responders in Incontinence (Leak) Events (IE)
Time frame: 12 Weeks
Percentage of Responders in Urgency Events (UE)
Time frame: 12 Weeks
Overall Responder Rate at 12 Weeks
Time frame: 12 Weeks
Overall Responder Rate at 12 Months
Time frame: 12 Months

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
12 Weeks Followed by Optional 12 Month Continuation	96	88

Primary outcome: Percentage of Responders in Voiding (Urinary Frequency) Events

Time frame: 12 Weeks. Count of participants. Unit: Participants

Measure	12 Weeks Followed by Optional 12 Month Continuation n = 89
Value	55

Population analysed: Number of Subjects with Reported Voiding Symptom (Avg \> 8 / day) at Baseline

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Length of Study (12 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12 Weeks Followed by Optional 12 Month Continuation	0 of 96 (0%)	17 of 96 (17.7%)	0 of 96

Limitations and caveats (from the sponsor): Potential limitations exist in the inherent design of the trial with use of patient-reported outcomes. This trial also had no control arm and relied on placebo rates available in the published literature. The end points were refined based on FDA feedback and the data was analyzed post-hoc. The opt-in process for the long-term follow-up population may have skewed in favor of patients with better outcomes during Phase I of the study and led to low number of subjects who entered Phase II.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder

RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wearable Bladder Modulation System in people with Overactive Bladder and Urinary Frequency, run by Avation Medical, Inc. at 9 sites 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 16 inclusion and 22 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: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Responders in Voiding (Urinary Frequency) Events (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547920.

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 26 Feb 2025.