Trial Outcomes & Findings for Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence (NCT NCT03556891)

NCT ID: NCT03556891

Last Updated: 2025-10-02

Results Overview

Responder rate

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 133 participants
• Primary outcome timeframe: 48 weeks after device activation.
• Results posted on: 2025-10-02

Participant Flow

Participant milestones

Measure	eCoin Tibial Nerve Stimulation eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Initial Pivotal Study STARTED	133
Initial Pivotal Study COMPLETED	120
Initial Pivotal Study NOT COMPLETED	13
Pivotal Extension Study STARTED	105
Pivotal Extension Study COMPLETED	41
Pivotal Extension Study NOT COMPLETED	64
Pivotal Re-extension STARTED	31
Pivotal Re-extension COMPLETED	21
Pivotal Re-extension NOT COMPLETED	10

Reasons for withdrawal

Measure	eCoin Tibial Nerve Stimulation eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Initial Pivotal Study Adverse Event	4
Initial Pivotal Study MRI Need	3
Initial Pivotal Study Device Failure	1
Initial Pivotal Study Death	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 Protocol Violation	1

Baseline Characteristics

Participant with Baseline Urgency Urinary Incontinence (UUI) Episodes of 0 excluded from Intention-to-Treat (ITT) analysis

Baseline characteristics by cohort

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Age, Continuous	64.0 years STANDARD_DEVIATION 11.0 • n=133 Participants
Sex: Female, Male Female	131 Participants n=133 Participants
Sex: Female, Male Male	2 Participants n=133 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=133 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants n=133 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=133 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=133 Participants
Race (NIH/OMB) Asian	2 Participants n=133 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=133 Participants
Race (NIH/OMB) Black or African American	6 Participants n=133 Participants
Race (NIH/OMB) White	112 Participants n=133 Participants
Race (NIH/OMB) More than one race	0 Participants n=133 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=133 Participants
Region of Enrollment United States	133 participants n=133 Participants
Urgency Urinary Incontinence (UUI) Episodes	4.32 episodes/day STANDARD_DEVIATION 3.08 • n=132 Participants • Participant with Baseline Urgency Urinary Incontinence (UUI) Episodes of 0 excluded from Intention-to-Treat (ITT) analysis
Urinary Voids	13.06 voids/day STANDARD_DEVIATION 2.67 • n=61 Participants • Includes patients in the ITT population whose baseline urinary voids value is more than 10 voids per day as prespecified "frequency" group.
Urgency Episodes	8.20 episodes/day STANDARD_DEVIATION 3.65 • n=132 Participants • Participant with Baseline UUI of 0 excluded from ITT analysis
Nocturia Episodes	2.54 episodes/day STANDARD_DEVIATION 1.04 • n=132 Participants • Participant with Baseline UUI of 0 excluded from ITT analysis
Overactive Bladder Questionnaire (OABq) - Short Form	66.1 units on a scale STANDARD_DEVIATION 19.6 • n=128 Participants • 5 participants did not complete OABq at baseline
Overactive Bladder Questionnaire (OABq) - Health Related Quality of Life	45.7 units on a scale STANDARD_DEVIATION 22.5 • n=128 Participants • 5 participants did not complete OABq at baseline

PRIMARY outcome

Timeframe: 48 weeks after device activation.

Population: Intent to Treat

Responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 60.0 to 76.0

PRIMARY outcome

Timeframe: 52 weeks after implantation.

Population: Intent to Treat plus subject with a baseline UUI of 0.

All adverse events will be reported in all patients up to 52 weeks after implantation.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	16 percentage of participants

SECONDARY outcome

Timeframe: 28 weeks after implantation

Population: Intent to Treat plus subject with a baseline UUI of 0.

All adverse events will be reported.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	14 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after device activation

Population: Intent to Treat

Moderate-term effectiveness data, responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 61.0 to 77.0

SECONDARY outcome

Timeframe: 96 weeks after device activation.

Population: ITT population with available UUI data at 96 weeks

Responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=69 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 67.0 to 87.0

SECONDARY outcome

Timeframe: 144 weeks after device activation

Population: ITT Population with available UUI data at 144 weeks

Responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=38 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 57.0 to 87.0

SECONDARY outcome

Timeframe: 205 weeks after device activation

Population: ITT population with available UUI data at 205 weeks.

Responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=23 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 39.0 to 80.0

SECONDARY outcome

Timeframe: 257 weeks after device activation

Population: ITT population with available UUI data at 257 weeks.

Responder rate

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=21 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
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 Interval 43.0 to 85.0

SECONDARY outcome

Timeframe: 96 weeks after implantation

Population: ITT population

All adverse events will be reported in all patients up to 96 weeks after implantation.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.	20 Percentage of participants

SECONDARY outcome

Timeframe: 144 weeks after implantation

Population: ITT population

All adverse events will be reported in all patients up to 144 weeks after implantation.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events	20 Percentage of participants

SECONDARY outcome

Timeframe: 205 weeks after implantation

Population: ITT population

All adverse events will be reported in all patients up to 205 weeks after implantation.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events	21 Percentage of participants

SECONDARY outcome

Timeframe: 257 weeks after implantation

Population: ITT population

All adverse events will be reported in all patients up to 257 weeks after implantation.

Outcome measures

Measure	eCoin Tibial Nerve Stimulation n=133 Participants eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events	23 Percentage of participants

Adverse Events

eCoin Tibial Nerve Stimulation

Serious events: 4 serious events

Other events: 40 other events

Deaths: 2 deaths

Serious adverse events

Measure	eCoin Tibial Nerve Stimulation n=133 participants at risk eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Infections and infestations Postoperative wound infection	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Infections and infestations Implant site infection	1.5% 2/133 • Number of events 2 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Skin and subcutaneous tissue disorders Contact Dermatitis	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.

Other adverse events

Measure	eCoin Tibial Nerve Stimulation n=133 participants at risk eCoin Tibial Nerve Stimulation: Subcutaneous stimulation of the tibial nerve using the eCoin device.
Product Issues Device stimulation issue	4.5% 6/133 • Number of events 6 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Product Issues Device dislocation	2.3% 3/133 • Number of events 3 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Product Issues Device malfunction	1.5% 2/133 • Number of events 2 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Infections and infestations Postoperative wound infection	5.3% 7/133 • Number of events 7 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Infections and infestations Wound abcess	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Injury, poisoning and procedural complications Incision site erythema	1.5% 2/133 • Number of events 2 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Injury, poisoning and procedural complications Incision site pain	3.8% 5/133 • Number of events 5 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Injury, poisoning and procedural complications Wound	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Injury, poisoning and procedural complications Wound dehiscence	2.3% 3/133 • Number of events 3 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
General disorders Implant site swelling	1.5% 2/133 • Number of events 2 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
General disorders Medical device site discomfort	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Musculoskeletal and connective tissue disorders Muscoskeletal discomfort	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 3/133 • Number of events 3 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Skin and subcutaneous tissue disorders Skin irritation	1.5% 2/133 • Number of events 2 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.
Gastrointestinal disorders Anal incontinence	0.75% 1/133 • Number of events 1 • 257 weeks post-implantation The analysis set is comprised of "treatment emergent" adverse events, defined as adverse events occurring on or after implantation or attempted implantation of eCoin. Importantly, all attempted implantations were successful; thus, the safety results are summarized for all implanted patients. At each follow-up visit, patients were asked to report any adverse events and it was recorded on the CRF.

Additional Information

Jackie Dister

Valencia Technologies

Phone: 7604294787

Email: jdister@valenciatechnologies.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place