Clinical trial NCT05381116: A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Urinary Urge Incontinence
Urge Incontinence
Keywords: Overactive Bladder
OAB
Urinary Incontinence
Neuromodulation
Bioelectronic Medicine
Urologic Disorders
Wearable
Digital Health
Closed-Loop
EMG
Sham
Continuous Sensing
Automatic Adjustment
Lead sponsor: Avation Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 all Study-related requirements and procedures
4. Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment
5. 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)
6. 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
7. Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline

Exclusion Criteria:

1. Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.)
2. 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
3. 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
4. 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
5. 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
6. Has symptoms of, been diagnosed, or being actively treated for benign prostatic hyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency)
7. Have a pacemaker or implanted defibrillator
8. Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas
9. 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)
10. Has been diagnosed with or has symptoms of polyuria (\>2500 cc urine output per day)
11. Has urinary retention or incomplete bladder emptying
12. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the months prior to enrollment)
13. Have had Botox treatment for their OAB in the previous 8 months
14. 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
15. Had PTNS treatment for OAB within 6 months prior to enrollment.
16. Use of investigational drug/device Therapy, for any reason, within past 12 weeks
17. Current use or implantation of an implanted device for treatment of their OAB or incontinence (including but not limited to sacral nerve stimulators)
18. Participation in another clinical Study during the term of the Study
19. 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
20. Has scar tissue, metal, or another implant or a large tattoo that might interfere with Therapy
21. Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
22. Has a skin condition, for example allergic reaction, rash or open wounds, in the area of where the Therapy Garment will be placed

Primary outcomes:
measure: The proportion of Subjects with a successful response
timeFrame: Blinded Lead-In Portion of Study,12 Weeks
Secondary outcomes:
measure: Quality of Life Endpoints: Questionnaires
timeFrame: Length of Study, 24 months
Other outcomes:
measure: Open-Label Phase Endpoints
timeFrame: Length of Study, 24 months
Locations:
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Oak Lawn
country: United States
facility: Women's Health Institute
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: San Antonio
country: United States
facility: Flourish Research
state: Texas
city: Webster
country: United States
facility: Tranquil Medical Rsearch
state: Texas
Study officials:
References: