FREEOAB Study for Overactive Bladder

NCT ID: NCT04547920

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2023-06-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wearable Bladder Modulation System

Intervention Type: DEVICE

Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

Interventions

Wearable Bladder Modulation System

Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device

Intervention Type: DEVICE

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 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avation Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AMHOAB2001

Identifier Type: -

Identifier Source: org_study_id