Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eCoin Tibial Nerve Stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eCoin Tibial Nerve Stimulation | Device | Subcutaneous stimulation of the tibial nerve using the eCoin device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 12 weeks after device activation. | |
| Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. | Instances of a related adverse event. | 16 weeks after device implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 24 weeks after device activation. | |
| Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. In the opinion of the investigator, individual is not a good candidate for participation in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clark Center for Urogynecology | Newport Beach | California | 92663 | United States | ||
| UnityPoint Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35536667 | Derived | Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, Clark M, Sen SK. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | eCoin Tibial Nerve Stimulation | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | eCoin Tibial Nerve Stimulation | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | Posted | Mean | Standard Deviation | episodes/day | 12 weeks after device activation. |
|
|
28 weeks after implantation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eCoin Tibial Nerve Stimulation | eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Dister | Valencia Technologies | 7604294787 | jdister@valenciatechnologies.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2019 | Mar 29, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Instances of a related adverse event
| 28 weeks after device implantation. |
| Waterloo |
| Iowa |
| 50703 |
| United States |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute) | Allentown | Pennsylvania | 18103 | United States |
| Urology Associates | Christchurch | 8013 | New Zealand |
| Roundhay Medical Centre | Nelson | New Zealand |
| Tauranga Urology Research Ltd | Tauranga | New Zealand |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean UUI Episodes/Day | Mean | Standard Deviation | episodes/day |
|
|
| Primary | Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. | Instances of a related adverse event. | Posted | Number | adverse events | 16 weeks after device implantation. |
|
|
|
| Secondary | Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | Posted | Mean | Standard Deviation | episodes/day | 24 weeks after device activation. |
|
|
|
| Secondary | Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. | Instances of a related adverse event | Posted | Number | adverse events | 28 weeks after device implantation. |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 6 |
| 23 |
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Incision site discomfort | General disorders | Systematic Assessment |
|
| Incision site swelling | General disorders | Systematic Assessment |
|
Not provided
Not provided
| 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 |
| D014555 | Urination Disorders |