FREEOAB Study for Overactive Bladder

NCT04547920 | Completed Results FDA Device

• 1 other identifier: AMHOAB2001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 9

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.

Conditions

Overactive Bladder; Urinary Frequency; Urinary Incontinence, Urge; Urinary Urgency

Keywords

Neuromodulation; Closed-Loop Neuromodulation; Wearable Neuromodulation; Tibial Nerve Stimulation; Continuous Sensing; Automatic Adjustment

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders in Voiding (Urinary Frequency) Events

  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.

  12 Weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Device: Wearable Bladder Modulation System

Interventions

Wearable Bladder Modulation System DEVICE

Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

12 Weeks Followed by Optional 12 Month Continuation

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avation Medical, Inc.: lead

Study Sites (9)

Stanford University

Stanford, California, 94305, United States

Location

The Pelvic Solutions Center

Denver, Colorado, 80218, United States

Location

Colorado Pelvic Floor Consultants

Englewood, Colorado, 80113, United States

Location

Women's Health Institute

Oak Lawn, Illinois, 60453, United States

Location

Urology of Indiana

Greenwood, Indiana, 46143, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Michigan Institute of Urology

Saint Clair Shores, Michigan, 48092, United States

Location

Tranquil Medical Rsearch

Webster, Texas, 77598, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic 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; Urinary Incontinence; Urination Disorders

Limitations and Caveats

Potential limitations exist in the inherent design of the trial with use of patient-reported outcomes. This trial also had no control arm and relied on placebo rates available in the published literature. The end points were refined based on FDA feedback and the data was analyzed post-hoc. The opt-in process for the long-term follow-up population may have skewed in favor of patients with better outcomes during Phase I of the study and led to low number of subjects who entered Phase II.

Results Point of Contact

• Title: Clinical Operations Project Manager
• Organization: Avation Medical

customercare@avation.com

(614) 591-4201

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: January 11, 2021
• Primary Completion: October 8, 2021
• Study Completion: June 15, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)