Incontinence, Urinary, Overactive Bladder, Urge Incontinence, Urinary Urge Incontinence
Conditions
Brief summary
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).
Interventions
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Sponsors
Valencia Technologies Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence. 2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.
Exclusion criteria
1\. In the opinion of the investigator, individual is not a good candidate for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 16 weeks after device implantation. | Instances of a related adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 28 weeks after device implantation. | Instances of a related adverse event |
Countries
New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| eCoin Tibial Nerve Stimulation eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | eCoin Tibial Nerve Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Mean UUI Episodes/Day | 4.8 episodes/day STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment New Zealand | 9 participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 6 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 12 weeks after device activation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| eCoin Tibial Nerve Stimulation | Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | -2.2 episodes/day | Standard Deviation 3.3 |
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.
Time frame: 16 weeks after device implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. | 8 adverse events |
Secondary
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time frame: 24 weeks after device activation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| eCoin Tibial Nerve Stimulation | Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | -3.7 episodes/day | Standard Deviation 1.2 |
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
Time frame: 28 weeks after device implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. | 8 adverse events |