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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Incontinence, Urge; Urinary Urgency; Urinary Frequency
• Intervention / Treatment: Device: Wearable Bladder Modulation System

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80218
      • The Pelvic Solutions Center
    • Englewood, Colorado, United States, 80113
      • Colorado Pelvic Floor Consultants
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Women's Health Institute
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Urology Of Indiana
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48092
      • Michigan Institute of Urology
  • Texas
    • Webster, Texas, United States, 77598
      • Tranquil Medical Rsearch
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12 Weeks Followed by Optional 12 Month Continuation; 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; Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Responder Rate at 12 Weeks	Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.	12 Weeks
Overall Responder Rate at 12 Months	Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.	12 Months
Percentage of Responders in Incontinence (Leak) Events (IE)	Percentage of Responders in Incontinence (Leak) Events (IE), 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 incontinence events per day, or returns to normal (0 events per day), at Week 12.	12 Weeks
Percentage of Responders in Urgency Events (UE)	Percentage of Responders in Urgency Events (UE), 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 urgency events per day, or returns to normal (0 events per day) at Week 12.	12 Weeks

Collaborators and Investigators

• Sponsor: Avation Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Neuromodulation; Closed-Loop Neuromodulation; Wearable Neuromodulation; Tibial Nerve Stimulation; Continuous Sensing; Automatic Adjustment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: AMHOAB2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No