A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder

Study Overview
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Brief Summary
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This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.

Official Title
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A Prospective, Sham-Controlled, Safety and Efficacy Study of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Modulation and Digital Health System With Objective Confirmation of Nerve Activation for Use in Home by Subjects With Overactive Bladder Syndrome

Conditions
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Overactive Bladder, Urinary Urge Incontinence, Urge Incontinence

Intervention / Treatment
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* Device: Avation System
* Device: Sham Avation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 all Study-related requirements and procedures Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment Have an average of 11 or more voiding events and/or 3 or more incontinent events per 24-hour period in a 3-Day Bladder Diary(a minimum of 30 voiding events over the 3 days measured by the Diary) 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 medications for at least 4 weeks prior to enrollment or throughout the Study Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline Exclusion Criteria: Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.) Have failed a third line treatment (PTNS, Botox or SNS) for their OAB because of lack of effectiveness within the 2 years prior to enrollment Have evidence of an uncontrolled 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 Has or had a significant untreated substance use disorder or polysubstance use disorder stemming from dependency-producing medications, alcohol, and/or illicit drugs less than 6 months prior to enrollment Are planning to or have scheduled a surgery, for any condition, that would require catheterization, or a prolonged hospital stay and affect the ability to ambulate, use the toilet, or complete Therapy during the first 12 weeks of the Study Has symptoms of, been diagnosed, or being actively treated for benign prostatic hyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency) Have a pacemaker or implanted defibrillator Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas Incontinence due to stress-predominant mixed urinary incontinence (greater that 60% of the time)or being actively treated for stress urinary incontinence(Diagnosed or by review of the Baseline 3-Day Bladder Diary) Has been diagnosed with or has symptoms of polyuria (>2500 cc urine output per day) Has urinary retention or incomplete bladder emptying Have a documented current or reoccurring Urinary Tract Infection (3 or more in the months prior to enrollment) Have had Botox treatment for their OAB in the previous 8 months Have used TENS anywhere on the body within the last year for any reason or anticipated use of TENS within 12 weeks of enrollment in pelvic region, back or legs for any reason Had PTNS treatment for OAB within 6 months prior to enrollment. Use of investigational drug/device Therapy, for any reason, within past 12 weeks Current use or implantation of an implanted device for treatment of their OAB or incontinence (including but not limited to sacral nerve stimulators) Participation in another clinical Study during the term of the Study Pregnant or planning to become pregnant during the Study. Female Subjects of childbearing potential who become pregnant during the Study will be withdrawn from the Study and will be asked to sign a separate pregnancy consent form to allow the Investigator and Sponsor to follow up on the Subject's pregnancy and outcome Has scar tissue, metal, or another implant or a large tattoo that might interfere with Therapy Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia) Has a skin condition, for example allergic reaction, rash or open wounds, in the area of where the Therapy Garment will be placed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Arm<br>Avation System | Device: Avation System<br>* Subjects will perform therapy with active Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, eligible Subjects from the Active Arm will be offered the opportunity to participate in the additional twenty one (21) month Open-Label Phase.<br>|
| Sham Comparator: Control Arm<br>Sham Avation System | Device: Sham Avation System<br>* Subjects will perform therapy with sham Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, all Subjects from the Sham Arm will be offered the opportunity to crossover and participate in the additional twenty one (21) month Open-Label Phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Outcome | Compare the average daily frequency of OAB symptoms between the Active Arm and Sham Arm using a 3-Day Bladder Diary to record daytime voids, nighttime voids, urge events, and urge incontinence events | Length of Study, on average 24 months | 
| Primary Safety Outcome | Total device related adverse events | Length of Study, on average 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Measures | Compare quality of life using validated quality of life questionnaires | Length of Study, on average 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, OAB, Urinary Incontinence, Neuromodulation, Bioelectronic Medicine, Urologic Disorders, Wearable, Digital Health