FREEOAB Study for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547920
• Other study ID #: AMHOAB2001
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2024
• Source: Avation Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The end points were refined based on FDA feedback and the data was analyzed post-hoc based on these endpoints, combining the group into a single study arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 15, 2023
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• Wearable Bladder Modulation System-1x per week
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation
• Wearable Bladder Modulation System - 3x per week
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation

Locations

Country	Name	City	State
United States	The Pelvic Solutions Center	Denver	Colorado
United States	Colorado Pelvic Floor Consultants	Englewood	Colorado
United States	Urology of Indiana	Greenwood	Indiana
United States	West Virginia University	Morgantown	West Virginia
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Women's Health Institute	Oak Lawn	Illinois
United States	Michigan Institute of Urology	Saint Clair Shores	Michigan
United States	Stanford University	Stanford	California
United States	Tranquil Medical Rsearch	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Avation Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Responders in Voiding (Urinary Frequency) Events	The proportion 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	System-Related Adverse Events	Number of System Related Adverse Events from Baseline to 12 Weeks	12 Weeks
Secondary	Proportion of Responders in Incontinence (Leak) Events (IE)	Proportion 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
Secondary	Proportion of Responders in Urgency Events (UE)	Proportion 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
Secondary	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
Secondary	Overall Responder Rate at 6 Months	Overall Responder Rate at 6 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.	6 Months