NCT04547920CompletedNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Avation Medical, Inc.
- Enrollment
- 96
- Locations
- 9
- Primary Endpoint
- Percentage of Responders in Voiding (Urinary Frequency) Events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
Exclusion Criteria
- •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)
Arms & Interventions
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.
Intervention: Wearable Bladder Modulation System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Responders in Incontinence (Leak) Events (IE)(12 Weeks)
- Percentage of Responders in Urgency Events (UE)(12 Weeks)
- Overall Responder Rate at 12 Weeks(12 Weeks)
- Overall Responder Rate at 12 Months(12 Months)
Investigators
Study Sites (9)
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