Trial Outcomes & Findings for Effectiveness of eCoin at Sensory and Subsensory Amplitudes (NCT NCT05882318)

Last Updated: 2025-11-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

3 months post-activation

Results posted on

2025-11-03

Participant Flow

Two subjects were excluded from randomization following enrollment. Both were due to withdraw of consent.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	18	18
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Only the per-protocol population (N=30) was analyzed for baseline demographics.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 months post-activation

Population: Per-Protocol Population

Outcome measures

Outcome measures
Measure	Subsensory n=17 Participants 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.	Sensory n=13 Participants 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.
Change in UUI Episodes Per Day	-2.73 UUI episodes per day Standard Deviation 1.8	-2.1 UUI episodes per day Standard Deviation 2.42

SECONDARY outcome

Timeframe: 2 months post-activation

Population: Per-Protocol Population with available UUI data at 2 months post-activation

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.

Outcome measures

Outcome measures
Measure	Subsensory n=17 Participants 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.	Sensory n=12 Participants 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.
Change in UUI Episodes Per Day	-2.14 UUI episodes per day Standard Deviation 2.58	-2.75 UUI episodes per day Standard Deviation 1.9

SECONDARY outcome

Timeframe: 4 months post-activation

Population: Per-Protocol Population with available UUI data at 4 months post-activation

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.

Outcome measures

Outcome measures
Measure	Subsensory n=17 Participants 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.	Sensory n=13 Participants 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.
Change in UUI Episodes Per Day	-2.96 UUI episodes per day Standard Deviation 2.12	-2.59 UUI episodes per day Standard Deviation 2.6

SECONDARY outcome

Timeframe: 2 and 3 months post-activation

Population: Per-Protocol Population all available data

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.

Outcome measures

Outcome measures
Measure	Subsensory n=17 Participants 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.	Sensory n=13 Participants 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.
Change in Overactive Bladder Health Related Quality of Life (HRQL) 2 months	22.78 Change in HRQL Score Standard Deviation 24.19	25.87 Change in HRQL Score Standard Deviation 21.6
Change in Overactive Bladder Health Related Quality of Life (HRQL) 3-months	22.59 Change in HRQL Score Standard Deviation 24.95	18.15 Change in HRQL Score Standard Deviation 22.63

SECONDARY outcome

Timeframe: 4 months post-activation

Population: Per-Protocol Population with available UUI data at 4 months post-activation

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.

Outcome measures

Outcome measures
Measure	Subsensory n=17 Participants 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.	Sensory n=13 Participants 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.
Change in Overactive Bladder Health Related Quality of Life (HRQL)	32.09 Change in HRQL Score Standard Deviation 26.2	22.03 Change in HRQL Score Standard Deviation 25.56

Adverse Events

Sensory

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Subsensory

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dylan Beyer

Valencia Technologies

Phone: +1 (661) 775-1414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sensory n=18 Participants 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.	Total n=36 Participants Total of all reporting groups	Subsensory n=18 Participants 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.
Sex: Female, Male Male	2 Participants n=18 Participants	4 Participants n=36 Participants	2 Participants n=18 Participants
Age, Continuous	66 years STANDARD_DEVIATION 13 • n=18 Participants	66 years STANDARD_DEVIATION 13 • n=36 Participants	65 years STANDARD_DEVIATION 14 • n=18 Participants
Sex: Female, Male Female	16 Participants n=18 Participants	32 Participants n=36 Participants	16 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	1 Participants n=36 Participants	1 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=18 Participants	33 Participants n=36 Participants	15 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	2 Participants n=36 Participants	2 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Race (NIH/OMB) Asian	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	1 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	1 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Baseline HRQL Score	53.07 HRQL Score STANDARD_DEVIATION 18.67 • n=18 Participants • All available baseline HRQoL Data	53.1 HRQL Score STANDARD_DEVIATION 20.11 • n=35 Participants • All available baseline HRQoL Data	53.13 HRQL Score STANDARD_DEVIATION 22.13 • n=17 Participants • All available baseline HRQoL Data
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	1 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	1 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Race (NIH/OMB) White	17 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	32 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	15 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Race (NIH/OMB) More than one race	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	0 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	2 Participants n=36 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.	1 Participants n=18 Participants • Only the per-protocol population (N=30) was analyzed for baseline demographics.
Region of Enrollment United States	18 participants n=18 Participants	30 participants n=36 Participants	18 participants n=18 Participants
Smoking Status, Current Smoker	0 Participants n=18 Participants	0 Participants n=36 Participants	0 Participants n=18 Participants
Baseline UUI Episodes per Day	4.91 UUI Episodes per day STANDARD_DEVIATION 2.12 • n=18 Participants • All available baseline UUI data.	5.39 UUI Episodes per day STANDARD_DEVIATION 2.6 • n=35 Participants • All available baseline UUI data.	5.9 UUI Episodes per day STANDARD_DEVIATION 3.01 • n=17 Participants • All available baseline UUI data.

Measure	Sensory n=18 participants at risk 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.	Subsensory n=18 participants at risk 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.
Injury, poisoning and procedural complications Incision Site Impaired Healing	11.1% 2/18 • Number of events 2 • 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.	0.00% 0/18 • 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.
Injury, poisoning and procedural complications Incision Site Discharge	5.6% 1/18 • Number of events 1 • 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.	0.00% 0/18 • 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.
Injury, poisoning and procedural complications Implant Site Oedema	5.6% 1/18 • Number of events 2 • 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.	5.6% 1/18 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incision Site Haemorrhage	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Infections and infestations Incision Site Cellulitis, Medical Device Site Cellulitis	5.6% 1/18 • Number of events 1 • 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.	0.00% 0/18 • 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.
Injury, poisoning and procedural complications Postoperative Wound Infection	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Injury, poisoning and procedural complications Incision Site Pain, Implant Site Bruising	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Injury, poisoning and procedural complications Site Incision Pain	11.1% 2/18 • Number of events 2 • 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.	0.00% 0/18 • 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.
Injury, poisoning and procedural complications Incision Site Pain, Incision Site Hyperaesthesia	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Tendon Pain	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Product Issues Device Stimulation issue	5.6% 1/18 • Number of events 1 • 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.	0.00% 0/18 • 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.
Injury, poisoning and procedural complications Dermatitis Contact	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
Injury, poisoning and procedural complications Implant Site Ulcer	5.6% 1/18 • Number of events 1 • 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.	5.6% 1/18 • Number of events 1 • 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.
General disorders Implant Site Pain	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
General disorders Medical Device Site Erythema	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.
General disorders Post Procedural Discomfort	0.00% 0/18 • 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.	5.6% 1/18 • Number of events 1 • 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.