Clinical trial NCT04547920: FREEOAB Study for Overactive Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Frequency
Urinary Incontinence, Urge
Urinary Urgency
Keywords: Neuromodulation
Closed-Loop Neuromodulation
Wearable Neuromodulation
Tibial Nerve Stimulation
Continuous Sensing
Automatic Adjustment
Lead sponsor: Avation Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female and 18 years of age or older at the time of enrollment
2. Willing and capable of giving informed consent
3. Willing and able to comply with study-related requirements and procedures
4. Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.
5. 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
6. Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary
7. Able to provide clear, thoughtful responses to questions and questionnaires
8. Able to toilet self and have and maintain personal hygiene
9. Able to don and doff the bladder modulation garment on their ankle area, replace Gel Pads and use the controller
10. 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.
11. Able to sense and tolerate stimulation for the entire 30-minute therapy session
12. Has detectable EMG signal in response to modulation system stimulation during an investigator supervised screening session
13. 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
14. Female subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
15. Have access to Wi-Fi at least weekly
16. Are capable of using the tablet-based controlling app

Exclusion Criteria:

1. 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.
2. Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body
3. Have a pacemaker or implanted defibrillator
4. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)
5. Current use of a marketed device for treatment of their OAB or incontinence (including but not limited to Interstim®)
6. Have had Botox treatment for their OAB in the previous 8 months
7. Current use of transcutaneous electric nerve stimulation (TENS) in pelvic region, back or legs
8. Had PTNS treatment within 6 months prior to enrollment
9. Use of investigational drug/device therapy within past 12 weeks
10. Is concomitantly participating in another clinical study
11. 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
12. Pregnant or planning to become pregnant within the next 12 weeks
13. Has scar tissue, metal, or other implant in the target ankle that would interfere with stimulation
14. Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
15. Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas.
16. Has a skin condition in the area of the ankle stimulation location that would preclude them from using surface stimulation
17. Has been diagnosed with incontinence due to neurogenic bladder
18. Have failed a third line treatment for their OAB because of lack of effectiveness in the last 2 years (PTNS, Botox, or SNS)
19. Urge incontinence due to stress predominant mixed urinary incontinence (greater that 60% of the time)
20. Have polyuria (\>2500 cc urine output per day)
21. Has urinary retention or incomplete bladder emptying
22. Has symptoms of benign prostatic hyperplasia (BPH -weak stream, straining, hesitancy or intermittency)

Primary outcomes:
measure: Percentage of Responders in Voiding (Urinary Frequency) Events
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percentage of Responders in Incontinence (Leak) Events (IE)
timeFrame: 12 Weeks
measure: Percentage of Responders in Urgency Events (UE)
timeFrame: 12 Weeks
measure: Overall Responder Rate at 12 Weeks
timeFrame: 12 Weeks
measure: Overall Responder Rate at 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: The Pelvic Solutions Center
state: Colorado
city: Englewood
country: United States
facility: Colorado Pelvic Floor Consultants
state: Colorado
city: Oak Lawn
country: United States
facility: Women's Health Institute
state: Illinois
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Saint Clair Shores
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Webster
country: United States
facility: Tranquil Medical Rsearch
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: