Urge Incontinence
Conditions
Keywords
Neuromodulation, eCoin device, Stimulation, Tibial nerve
Brief summary
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: * The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Interventions
DEVICEeCoin Peripheral Neurostimulator System
The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.
Sponsors
Valencia Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component 2. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS). 3. Individual is determined to be a suitable surgical candidate by physician. Key
Exclusion criteria
1. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. 2. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). 3. Individual has clinically significant bladder outlet obstruction. 4. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months. 5. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed. 6. Individual has post void residual greater than 200 cc. 7. Individual has an active diagnosis of bladder, urethral, or prostate cancer. 8. Individual has had a prior anti-stress incontinence surgery within the last year. 9. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7). 10. Individual is neutropenic or immune-compromised. 11. Individual has lower extremity pathology such as: 1. Previous surgery and/or significant scarring at the planned implant location 2. Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders 3. Clinically significant peripheral neuropathy in the lower extremities 4. Pitting edema at the implant location (≥ 2+ is excluded) 5. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg 6. Moderate to severe varicose veins 7. Open wounds or recent trauma 8. Arterial and/or vasculitis disease in the lower extremities 9. Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region 12. Individual has neurogenic bladder dysfunction. 13. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. 14. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in UUI Episodes Per Day | 3 months post-activation | The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in UUI Episodes Per Day | 2 months post-activation | Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline. |
| Change in Overactive Bladder Health Related Quality of Life (HRQL) | 2 and 3 months post-activation | Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey. Higher scores on the HRQL portion indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst). A positive change in score indicates an improvement in quality of life. |
Countries
United States
Participant flow
Pre-assignment details
Two subjects were excluded from randomization following enrollment. Both were due to withdraw of consent.
Participants by arm
| Arm | Count |
|---|---|
| Sensory eCoin Peripheral Neurostimulator System: The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.
Participants in the sensory treatment arm will be programmed to their sensory threshold. | 18 |
| Subsensory eCoin Peripheral Neurostimulator System: The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.
Participants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold. | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Subsensory | Total | Sensory |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 14 | 66 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 13 |
| Baseline HRQL Score | 53.13 HRQL Score STANDARD_DEVIATION 22.13 | 53.1 HRQL Score STANDARD_DEVIATION 20.11 | 53.07 HRQL Score STANDARD_DEVIATION 18.67 |
| Baseline UUI Episodes per Day | 5.9 UUI Episodes per day STANDARD_DEVIATION 3.01 | 5.39 UUI Episodes per day STANDARD_DEVIATION 2.6 | 4.91 UUI Episodes per day STANDARD_DEVIATION 2.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 33 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 32 Participants | 17 Participants |
| Region of Enrollment United States | 18 participants | 30 participants | 18 participants |
| Sex: Female, Male Female | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
| Smoking Status, Current Smoker | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 7 / 18 | 6 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in UUI Episodes Per Day
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 3 months post-activation
Population: Per-Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensory | Change in UUI Episodes Per Day | -2.1 UUI episodes per day | Standard Deviation 2.42 |
| Subsensory | Change in UUI Episodes Per Day | -2.73 UUI episodes per day | Standard Deviation 1.8 |
Secondary
Change in Overactive Bladder Health Related Quality of Life (HRQL)
Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey. Higher scores on the HRQL portion indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst). A positive change in score indicates an improvement in quality of life.
Time frame: 2 and 3 months post-activation
Population: Per-Protocol Population all available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 2 months | 25.87 Change in HRQL Score | Standard Deviation 21.6 |
| Sensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 3-months | 18.15 Change in HRQL Score | Standard Deviation 22.63 |
| Subsensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 2 months | 22.78 Change in HRQL Score | Standard Deviation 24.19 |
| Subsensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 3-months | 22.59 Change in HRQL Score | Standard Deviation 24.95 |
Secondary
Change in Overactive Bladder Health Related Quality of Life (HRQL)
Change from baseline in patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey. Higher scores on the HRQL indicate better quality of life. The maximum HRQL domain score is 100 (best) and the minimum HRQL score is 0 (worst). A positive change in score indicates an improvement in quality of life.
Time frame: 4 months post-activation
Population: Per-Protocol Population with available UUI data at 4 months post-activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 22.03 Change in HRQL Score | Standard Deviation 25.56 |
| Subsensory | Change in Overactive Bladder Health Related Quality of Life (HRQL) | 32.09 Change in HRQL Score | Standard Deviation 26.2 |
Secondary
Change in UUI Episodes Per Day
Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 2 months post-activation
Population: Per-Protocol Population with available UUI data at 2 months post-activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensory | Change in UUI Episodes Per Day | -2.75 UUI episodes per day | Standard Deviation 1.9 |
| Subsensory | Change in UUI Episodes Per Day | -2.14 UUI episodes per day | Standard Deviation 2.58 |
Secondary
Change in UUI Episodes Per Day
A secondary endpoint is to explore the change in UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Time frame: 4 months post-activation
Population: Per-Protocol Population with available UUI data at 4 months post-activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensory | Change in UUI Episodes Per Day | -2.59 UUI episodes per day | Standard Deviation 2.6 |
| Subsensory | Change in UUI Episodes Per Day | -2.96 UUI episodes per day | Standard Deviation 2.12 |