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

NCT05381116 | Terminated FDA Device

• 1 other identifier: AMHOAB2101
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• The proportion of Subjects with a successful response

  The proportion of Subjects with a successful response, where success is defined as: For enrolled Subjects that meet the inclusion criteria for average voids per day (frequency): a Subject that achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 4), in average voids per day relative to an upper normal limit of an average of 8 voids per day, or For enrolled Subjects that meet the inclusion criteria for incontinence events per day: a Subject that achieves a 50% or greater reduction from baseline (Visit 1) to Week 12 (Visit 4) in average incontinence events (IE) per day.

  Blinded Lead-In Portion of Study,12 Weeks

Secondary Outcomes (1)

• Quality of Life Endpoints: Questionnaires

  Length of Study, 24 months

Other Outcomes (1)

• Open-Label Phase Endpoints

  Length of Study, 24 months

Study Arms (2)

Experimental Arm

ACTIVE COMPARATOR

Avation System

Device: Avation System

Control Arm

SHAM COMPARATOR

Sham Avation System

Device: Sham Avation System

Interventions

Avation System DEVICE

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.

Experimental Arm

Sham Avation System DEVICE

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avation Medical, Inc.: lead

Study Sites (6)

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Women's Health Institute

Oak Lawn, Illinois, 60453, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Flourish Research

San Antonio, Texas, 78229, United States

Location

Tranquil Medical Rsearch

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence; Urologic Diseases

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 19, 2022
• Study Start: April 14, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

US (6)