FREEOAB Study for Overactive Bladder

Completed · Not applicable

Conditions studied: Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency

In brief

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.

Key facts

Study ID: NCT04547920
Run by: Avation Medical, Inc.
People needed: 96
Starts: 2021-01-11
Expected to finish: 2023-06-15
Last updated by the study team: 2025-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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
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)

Where it is running

Stanford University — Stanford, California, United States
The Pelvic Solutions Center — Denver, Colorado, United States
Colorado Pelvic Floor Consultants — Englewood, Colorado, United States
Women's Health Institute — Oak Lawn, Illinois, United States
Urology of Indiana — Greenwood, Indiana, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
Michigan Institute of Urology — Saint Clair Shores, Michigan, United States
Tranquil Medical Rsearch — Webster, Texas, United States
West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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