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

Sponsor

Avation Medical, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05381116

Collaborator

(none)

150

Enrollment

Location

Arms

34.6

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Urinary Urge Incontinence Urge Incontinence	Device: Avation System Device: Sham Avation System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental Arm Avation System	Device: Avation System 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.
Sham Comparator: Control Arm Sham Avation System	Device: Sham Avation System 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.

Arm

Intervention/Treatment

Active Comparator: Experimental Arm

Avation System

Device: Avation System

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.

Sham Comparator: Control Arm

Sham Avation System

Device: Sham Avation System

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.

Outcome Measures

Primary Outcome Measures

Primary Efficacy Outcome [Length of Study, on average 24 months]
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
Primary Safety Outcome [Length of Study, on average 24 months]
Total device related adverse events

Secondary Outcome Measures

Quality of Life Measures [Length of Study, on average 24 months]
Compare quality of life using validated quality of life questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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