Incontinence, Urinary, Overactive Bladder, Urge Incontinence, Urinary Urge Incontinence
Conditions
Brief summary
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.
Detailed description
This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE. Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation). Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.
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
Primary Inclusion Criteria: 1. Women and men between 18 and 80 years old. 2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months. 3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists). 4. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation. Primary
Exclusion criteria
1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes. 2. Clinically significant bladder outlet obstruction. 3. Clinically significant pelvic organ prolapse beyond the hymenal ring. 4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 48 weeks after device activation. | Responder rate |
| Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. | 52 weeks after implantation. | All adverse events will be reported in all patients up to 52 weeks after implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary | 96 weeks after device activation. | Responder rate |
| Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 144 weeks after device activation | Responder rate |
| Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. | 28 weeks after implantation | All adverse events will be reported. |
| Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events | 144 weeks after implantation | All adverse events will be reported in all patients up to 144 weeks after implantation. |
| Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events | 205 weeks after implantation | All adverse events will be reported in all patients up to 205 weeks after implantation. |
| Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events. | 96 weeks after implantation | All adverse events will be reported in all patients up to 96 weeks after implantation. |
| Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 24 weeks after device activation | Moderate-term effectiveness data, responder rate |
Countries
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. | 133 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Initial Pivotal Study | Adverse Event | 4 |
| Initial Pivotal Study | Death | 1 |
| Initial Pivotal Study | Device Failure | 1 |
| Initial Pivotal Study | Lost to Follow-up | 1 |
| Initial Pivotal Study | Missing at random | 1 |
| Initial Pivotal Study | Missing due to COVID | 1 |
| Initial Pivotal Study | MRI Need | 3 |
| Initial Pivotal Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | eCoin Tibial Nerve Stimulation |
|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Nocturia Episodes | 2.54 episodes/day STANDARD_DEVIATION 1.04 |
| Overactive Bladder Questionnaire (OABq) - Health Related Quality of Life | 45.7 units on a scale STANDARD_DEVIATION 22.5 |
| Overactive Bladder Questionnaire (OABq) - Short Form | 66.1 units on a scale STANDARD_DEVIATION 19.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 112 Participants |
| Region of Enrollment United States | 133 participants |
| Sex: Female, Male Female | 131 Participants |
| Sex: Female, Male Male | 2 Participants |
| Urgency Episodes | 8.20 episodes/day STANDARD_DEVIATION 3.65 |
| Urgency Urinary Incontinence (UUI) Episodes | 4.32 episodes/day STANDARD_DEVIATION 3.08 |
| Urinary Voids | 13.06 voids/day STANDARD_DEVIATION 2.67 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 133 |
| other Total, other adverse events | 40 / 133 |
| serious Total, serious adverse events | 4 / 133 |
Outcome results
Primary
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported in all patients up to 52 weeks after implantation.
Time frame: 52 weeks after implantation.
Population: Intent to Treat plus subject with a baseline UUI of 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. | 16 percentage of participants |
Primary
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Time frame: 48 weeks after device activation.
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 68 percentage of participants |
Secondary
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 144 weeks after implantation.
Time frame: 144 weeks after implantation
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events | 20 Percentage of participants |
Secondary
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported in all patients up to 96 weeks after implantation.
Time frame: 96 weeks after implantation
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events. | 20 Percentage of participants |
Secondary
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 257 weeks after implantation.
Time frame: 257 weeks after implantation
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events | 23 Percentage of participants |
Secondary
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events
All adverse events will be reported in all patients up to 205 weeks after implantation.
Time frame: 205 weeks after implantation
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events | 21 Percentage of participants |
Secondary
Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Moderate-term effectiveness data, responder rate
Time frame: 24 weeks after device activation
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 69 percentage of participants |
Secondary
Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported.
Time frame: 28 weeks after implantation
Population: Intent to Treat plus subject with a baseline UUI of 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. | 14 percentage of participants |
Secondary
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary
Responder rate
Time frame: 96 weeks after device activation.
Population: ITT population with available UUI data at 96 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary | 78 Percentage of participants |
Secondary
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Time frame: 205 weeks after device activation
Population: ITT population with available UUI data at 205 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 61 Percentage of participants |
Secondary
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Time frame: 257 weeks after device activation
Population: ITT population with available UUI data at 257 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 67 Percentage of participants |
Secondary
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Time frame: 144 weeks after device activation
Population: ITT Population with available UUI data at 144 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| eCoin Tibial Nerve Stimulation | Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. | 74 Percentage of participants |