Trial Outcomes & Findings for eCoin for OAB Feasibility Follow-on Study (NCT NCT03655054)
NCT ID: NCT03655054
Last Updated: 2022-10-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
12 weeks after device activation.
Results posted on
2022-10-17
Participant Flow
Participant milestones
| Measure |
eCoin Tibial Nerve Stimulation
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
eCoin Tibial Nerve Stimulation
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
eCoin for OAB Feasibility Follow-on Study
Baseline characteristics by cohort
| Measure |
eCoin Tibial Nerve Stimulation
n=23 Participants
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Mean UUI Episodes/Day
|
4.8 episodes/day
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after device activation.Outcome measures
| Measure |
eCoin Tibial Nerve Stimulation
n=23 Participants
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
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 outcome
Timeframe: 16 weeks after device implantation.Instances of a related adverse event.
Outcome measures
| Measure |
eCoin Tibial Nerve Stimulation
n=23 Participants
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
|
8 adverse events
|
SECONDARY outcome
Timeframe: 24 weeks after device activation.Outcome measures
| Measure |
eCoin Tibial Nerve Stimulation
n=22 Participants
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
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 outcome
Timeframe: 28 weeks after device implantation.Instances of a related adverse event
Outcome measures
| Measure |
eCoin Tibial Nerve Stimulation
n=22 Participants
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.
|
8 adverse events
|
Adverse Events
eCoin Tibial Nerve Stimulation
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
eCoin Tibial Nerve Stimulation
n=23 participants at risk
eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Incision site erythema
|
4.3%
1/23 • Number of events 1 • 28 weeks after implantation
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.3%
1/23 • Number of events 1 • 28 weeks after implantation
|
|
General disorders
Incision site discomfort
|
13.0%
3/23 • Number of events 3 • 28 weeks after implantation
|
|
General disorders
Incision site swelling
|
13.0%
3/23 • Number of events 3 • 28 weeks after implantation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place