Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
Conditions
Keywords
Neuromodulation, Closed-Loop Neuromodulation, Wearable Neuromodulation, Tibial Nerve Stimulation, Continuous Sensing, Automatic Adjustment
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.
Interventions
DEVICEWearable Bladder Modulation System
Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device
Sponsors
Avation Medical, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders in Voiding (Urinary Frequency) Events | 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders in Incontinence (Leak) Events (IE) | 12 Weeks | 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. |
| Percentage of Responders in Urgency Events (UE) | 12 Weeks | 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. |
| Overall Responder Rate at 12 Weeks | 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. |
| Overall Responder Rate at 12 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.
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 for the duration of the study. | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | 12 Weeks Followed by Optional 12 Month Continuation |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 164 centimeters (cm) STANDARD_DEVIATION 9.11 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black / African American | 10 Participants |
| Race/Ethnicity, Customized Other | 6 Participants |
| Race/Ethnicity, Customized White / Caucasian | 77 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 11 Participants |
| Weight | 83.7 kilograms (kg) STANDARD_DEVIATION 26.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 96 |
| other Total, other adverse events | 17 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
Primary
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.
Time frame: 12 Weeks
Population: Number of Subjects with Reported Voiding Symptom (Avg \> 8 / day) at Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation | Percentage of Responders in Voiding (Urinary Frequency) Events | 55 Participants |
Secondary
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.
Time frame: 12 Months
Population: \# of Subjects with ≥ 50% Change in Any Symptom
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation | Overall Responder Rate at 12 Months | 30 Participants |
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.
Time frame: 12 Weeks
Population: Number of Subjects with ≥ 50% Change in Any Symptom
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation | Overall Responder Rate at 12 Weeks | 74 Participants |
Secondary
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.
Time frame: 12 Weeks
Population: Number of Subjects with Reported Urgency Symptom (Avg Daily Urges \> 0) at Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation | Percentage of Responders in Incontinence (Leak) Events (IE) | 47 Participants |
Secondary
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.
Time frame: 12 Weeks
Population: Number of Subjects with Reported Incontinence Symptom (Avg Daily Leaks \> 0) at Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 Weeks Followed by Optional 12 Month Continuation | Percentage of Responders in Urgency Events (UE) | 41 Participants |