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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensory | Experimental | Participants in the sensory treatment arm will be programmed to their sensory threshold. |
|
| Subsensory | Experimental | Participants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eCoin Peripheral Neurostimulator System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months post-activation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
Individual has clinically significant bladder outlet obstruction.
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.
Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.
Individual has post void residual greater than 200 cc.
Individual has an active diagnosis of bladder, urethral, or prostate cancer.
Individual has had a prior anti-stress incontinence surgery within the last year.
Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7).
Individual is neutropenic or immune-compromised.
Individual has lower extremity pathology such as:
Individual has neurogenic bladder dysfunction.
Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Research | Downey | California | 90241 | United States | ||
| Urology Associates of Central California |
Two subjects were excluded from randomization following enrollment. Both were due to withdraw of consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 are programmed to their sensory threshold. |
| FG001 | 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 are programmed to approximately 75% of their sensory threshold. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of baseline participants refers to the number of participants who were implanted and randomized into a study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-Protocol Population | Posted | Mean | Standard Deviation | UUI episodes per day | 3 months post-activation |
|
4 months post-activation
The analysis set is comprised of "treatment emergent" adverse events, defined as device- or procedure-related adverse events occurring on or after implantation or attempted implantation of eCoin. Safety results are summarized for all implanted patients. At each follow-up visit, adverse events were recorded on the CRF. Patients were unblinded following the 3 month visit and had the option to reprogram their devices. Results are reported based on the patient's original treatment arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical Device Site Erythema | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dylan Beyer | Valencia Technologies | +1 (661) 775-1414 | dbeyer@valenciatechnologies.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2023 | Apr 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2023 | Apr 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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. | 4 months post-activation |
| 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. | 2 and 3 months post-activation |
| 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. | 4 months post-activation |
| Fresno |
| California |
| 93720 |
| United States |
| The Iowa Clinic | Ankeny | Iowa | 50023 | United States |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | United States |
| Adult & Pediatric Urology P.C. | Omaha | Nebraska | 68114 | United States |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | United States |
| Institute for Female Pelvic Medicine | Allentown | Pennsylvania | 18103 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only the per-protocol population (N=30) was analyzed for baseline demographics. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status, Current Smoker | Count of Participants | Participants |
|
| Baseline UUI Episodes per Day | All available baseline UUI data. | Mean | Standard Deviation | UUI Episodes per day |
|
| Baseline HRQL Score | 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). | All available baseline HRQoL Data | Mean | Standard Deviation | HRQL Score |
|
| OG001 | 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 are programmed to approximately 75% of their sensory threshold. |
|
|
| 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. | Per-Protocol Population with available UUI data at 2 months post-activation | Posted | Mean | Standard Deviation | UUI episodes per day | 2 months post-activation |
|
|
|
| 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. | Per-Protocol Population with available UUI data at 4 months post-activation | Posted | Mean | Standard Deviation | UUI episodes per day | 4 months post-activation |
|
|
|
| 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. | Per-Protocol Population all available data | Posted | Mean | Standard Deviation | Change in HRQL Score | 2 and 3 months post-activation |
|
|
|
| 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. | Per-Protocol Population with available UUI data at 4 months post-activation | Posted | Mean | Standard Deviation | Change in HRQL Score | 4 months post-activation |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 7 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 6 | 18 |
| Post Procedural Discomfort | General disorders | Systematic Assessment |
|
| Incision Site Impaired Healing | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision Site Discharge | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Implant Site Oedema | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision Site Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision Site Cellulitis, Medical Device Site Cellulitis | Infections and infestations | Systematic Assessment |
|
| Postoperative Wound Infection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision Site Pain, Implant Site Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Site Incision Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision Site Pain, Incision Site Hyperaesthesia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tendon Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Device Stimulation issue | Product Issues | Systematic Assessment |
|
| Dermatitis Contact | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Implant Site Ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Implant Site Pain | General disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 3-months |
|
|