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FREEOAB Study for Overactive Bladder | Clinical Trials | Clareo Health

COMPLETEDNA

FREEOAB Study for Overactive Bladder

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

NCT04547920•Avation Medical, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

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
+12 more criteria

Locations (9)

Stanford University

Stanford, California, United States

The Pelvic Solutions Center

Denver, Colorado, United States

Colorado Pelvic Floor Consultants

Englewood, Colorado, United States

Women's Health Institute

Oak Lawn, Illinois, United States

Urology of Indiana

Greenwood, Indiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Michigan Institute of Urology

Saint Clair Shores, Michigan, United States

Tranquil Medical Rsearch

Webster, Texas, United States

West Virginia University

Morgantown, West Virginia, United States

Key Dates

Start Date

January 11, 2021

Primary Completion Date

October 8, 2021

Completion Date

June 15, 2023

Last Updated

February 26, 2025

Enrollment

ACTUAL participants

Conditions

Overactive BladderUrinary FrequencyUrinary Incontinence, UrgeUrinary Urgency

Interventions

Wearable Bladder Modulation System

DEVICE

TReating Incontinence for Underlying Mental and Physical Health

NCT05362292

Urinary Incontinence, UrgeUrinary Incontinence+4 more

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RECRUITINGNA

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407

Overactive Bladder (OAB)

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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FREEOAB Study for Overactive Bladder

Inclusion Criteria

Exclusion Criteria

TReating Incontinence for Underlying Mental and Physical Health

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks