Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT05882318
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dbeyer@valenciatechnologies.com', 'phone': '+1 (661) 775-1414', 'title': 'Dylan Beyer', 'organization': 'Valencia Technologies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months post-activation', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Sensory', 'description': '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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subsensory', 'description': '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.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Medical Device Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Procedural Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant Site Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Cellulitis, Medical Device Site Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Pain, Implant Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Site Incision Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision Site Pain, Incision Site Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Stimulation issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant Site Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in UUI Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'OG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-activation', 'description': '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.\n\nA negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.', 'unitOfMeasure': 'UUI episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population'}, {'type': 'SECONDARY', 'title': 'Change in UUI Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'OG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.75', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months post-activation', 'description': 'Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary.\n\nA negative number shows a reduction in UUI episodes which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.', 'unitOfMeasure': 'UUI episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population with available UUI data at 2 months post-activation'}, {'type': 'SECONDARY', 'title': 'Change in UUI Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'OG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.59', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-2.96', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months post-activation', 'description': 'A secondary endpoint is to explore the change in UUI episodes per day on a 3-day voiding diary.\n\nA negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.', 'unitOfMeasure': 'UUI episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population with available UUI data at 4 months post-activation'}, {'type': 'SECONDARY', 'title': 'Change in Overactive Bladder Health Related Quality of Life (HRQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'OG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'classes': [{'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.87', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '22.78', 'spread': '24.19', 'groupId': 'OG001'}]}]}, {'title': '3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.15', 'spread': '22.63', 'groupId': 'OG000'}, {'value': '22.59', 'spread': '24.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 and 3 months post-activation', 'description': '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.\n\nHigher 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).\n\nA positive change in score indicates an improvement in quality of life.', 'unitOfMeasure': 'Change in HRQL Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population all available data'}, {'type': 'SECONDARY', 'title': 'Change in Overactive Bladder Health Related Quality of Life (HRQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'OG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.03', 'spread': '25.56', 'groupId': 'OG000'}, {'value': '32.09', 'spread': '26.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months post-activation', 'description': '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.\n\nHigher 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).\n\nA positive change in score indicates an improvement in quality of life.', 'unitOfMeasure': 'Change in HRQL Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population with available UUI data at 4 months post-activation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm are programmed to their sensory threshold.'}, {'id': 'FG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm are programmed to approximately 75% of their sensory threshold.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Two subjects were excluded from randomization following enrollment. Both were due to withdraw of consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensory', 'description': '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.\n\nParticipants in the sensory treatment arm will be programmed to their sensory threshold.'}, {'id': 'BG001', 'title': 'Subsensory', 'description': '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.\n\nParticipants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '13', 'groupId': 'BG000'}, {'value': '65', 'spread': '14', 'groupId': 'BG001'}, {'value': '66', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only the per-protocol population (N=30) was analyzed for baseline demographics.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status, Current Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline UUI Episodes per Day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '2.12', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '3.01', 'groupId': 'BG001'}, {'value': '5.39', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'UUI Episodes per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available baseline UUI data.'}, {'title': 'Baseline HRQL Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.07', 'spread': '18.67', 'groupId': 'BG000'}, {'value': '53.13', 'spread': '22.13', 'groupId': 'BG001'}, {'value': '53.1', 'spread': '20.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey\n\nHigher 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).', 'unitOfMeasure': 'HRQL Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All available baseline HRQoL Data'}], 'populationDescription': 'The number of baseline participants refers to the number of participants who were implanted and randomized into a study arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-24', 'size': 836079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-10T17:47', 'hasProtocol': True}, {'date': '2023-08-16', 'size': 616463, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-10T17:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2023-05-19', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-17', 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in UUI Episodes Per Day', 'timeFrame': '3 months post-activation', 'description': '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.\n\nA negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in UUI Episodes Per Day', 'timeFrame': '2 months post-activation', 'description': 'Change in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary.\n\nA negative number shows a reduction in UUI episodes which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.'}, {'measure': 'Change in UUI Episodes Per Day', 'timeFrame': '4 months post-activation', 'description': 'A secondary endpoint is to explore the change in UUI episodes per day on a 3-day voiding diary.\n\nA negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline.\n\nA positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.'}, {'measure': 'Change in Overactive Bladder Health Related Quality of Life (HRQL)', 'timeFrame': '2 and 3 months post-activation', 'description': '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.\n\nHigher 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).\n\nA positive change in score indicates an improvement in quality of life.'}, {'measure': 'Change in Overactive Bladder Health Related Quality of Life (HRQL)', 'timeFrame': '4 months post-activation', 'description': '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.\n\nHigher 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).\n\nA positive change in score indicates an improvement in quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Neuromodulation', 'eCoin device', 'Stimulation', 'Tibial nerve'], 'conditions': ['Urge Incontinence']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is:\n\n* The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy\n\nParticipants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component\n2. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).\n3. Individual is determined to be a suitable surgical candidate by physician.\n\nKey Exclusion Criteria:\n\n1. Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.\n2. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).\n3. Individual has clinically significant bladder outlet obstruction.\n4. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months.\n5. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed.\n6. Individual has post void residual greater than 200 cc.\n7. Individual has an active diagnosis of bladder, urethral, or prostate cancer.\n8. Individual has had a prior anti-stress incontinence surgery within the last year.\n9. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\\>7).\n10. Individual is neutropenic or immune-compromised.\n11. Individual has lower extremity pathology such as:\n\n 1. Previous surgery and/or significant scarring at the planned implant location\n 2. Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders\n 3. Clinically significant peripheral neuropathy in the lower extremities\n 4. Pitting edema at the implant location (≥ 2+ is excluded)\n 5. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg\n 6. Moderate to severe varicose veins\n 7. Open wounds or recent trauma\n 8. Arterial and/or vasculitis disease in the lower extremities\n 9. Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region\n12. Individual has neurogenic bladder dysfunction.\n13. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.\n14. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)"}, 'identificationModule': {'nctId': 'NCT05882318', 'acronym': 'ESSENCE', 'briefTitle': 'Effectiveness of eCoin at Sensory and Subsensory Amplitudes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valencia Technologies Corporation'}, 'officialTitle': 'Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life', 'orgStudyIdInfo': {'id': '111-6133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensory', 'description': 'Participants in the sensory treatment arm will be programmed to their sensory threshold.', 'interventionNames': ['Device: eCoin Peripheral Neurostimulator System']}, {'type': 'EXPERIMENTAL', 'label': 'Subsensory', 'description': 'Participants in the subsensory treatment arm will be programmed to approximately 75% of their sensory threshold.', 'interventionNames': ['Device: eCoin Peripheral Neurostimulator System']}], 'interventions': [{'name': 'eCoin Peripheral Neurostimulator System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sensory', 'Subsensory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90241', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Research', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Urology Associates of Central California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '50023', 'city': 'Ankeny', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Iowa Clinic', 'geoPoint': {'lat': 41.72971, 'lon': -93.60577}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cypress Medical Research Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult & Pediatric Urology P.C.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Associated Urologists of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Institute for Female Pelvic Medicine', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valencia Technologies Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}