Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT03150758
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2017-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CancerCenterResearch@ccf.org', 'phone': '1-800-223-2273', 'title': 'Dr. Eric Klein', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 30 days from end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Electrical Stimulation', 'description': 'Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded\n\n10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds\n\n7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Cavernosal Nerve Stimulation Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Stimulation', 'description': 'Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded\n\n10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds\n\n7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 21 days after prostatectomy', 'description': 'Median value of "maximum stimulation pattern men received prior to erection" in responders', 'unitOfMeasure': 'mA', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who responded to therapy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrical Stimulation', 'description': 'Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded\n\n10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds\n\n7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrical Stimulation', 'description': 'Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded\n\n10Hz + 100 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n10Hz + 200 micro-seconds: 10Hz Electrical Stimulation with a pulse width of 200 micro-seconds\n\n7Hz + 100 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 100 micro-seconds\n\n7Hz + 200 micro-seconds: 7Hz Electrical Stimulation with a pulse width of 200 micro-seconds'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who were put on study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-29', 'size': 318063, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-15T12:01', 'hasProtocol': True}, {'date': '2018-06-01', 'size': 164645, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-10T08:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2017-05-10', 'resultsFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-11', 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Cavernosal Nerve Stimulation Threshold', 'timeFrame': 'Up to 21 days after prostatectomy', 'description': 'Median value of "maximum stimulation pattern men received prior to erection" in responders'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Erectile Disfunction', 'Urinary Function'], 'conditions': ['Prostatectomy']}, 'descriptionModule': {'briefSummary': 'Erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not provided benefit. Electrical stimulation has been demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular systems. Therefore, electrical stimulation of the cavernosal nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy. This pilot study is intended to determine the threshold of electrical stimulation that results in penile erection, as defined by persistent intracavernosal pressure increase, such that future studies of sub-threshold stimulation may be pursued.', 'detailedDescription': 'Objective:\n\nTo determine the cavernosal nerve electrical stimulation amplitude thresholds at which an erection, as indicated by persistent increases in intracavernosal pressure, occurs for various stimuli of fixed frequency and fixed pulse-width.\n\nStudy Design:\n\nThis is a prospective pilot study used to determine a threshold range of cavernosal nerve electrical stimulation parameters that result in penile erection. Assignment to the order of stimulation paradigms will be randomized. No placebos are used. No blinding is used.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must have prostate cancer being treated via radical prostatectomy by a single surgeon (primary investigator) with planned intraoperative nerve sparing.\n* Subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a Sexual Health Inventory for Men (SHIM) / International Index of Erectile Function (IIEF-2) score 22 or higher, which is collected as part of routine care.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM / IIEF-2 21 or lower, which is collected as part of routine care.\n* Lack of successful intraoperative nerve sparing.\n* Neurologic, metabolic, or vascular diseases that may negatively impact erectile function, such as: diabetes mellitus, peripheral vascular disease, coronary artery disease, stroke, multiple sclerosis, parkinson's disease, multiple systems atrophy, epilepsy, or spinal cord injury.\n* Inability to provide a fully informed consent."}, 'identificationModule': {'nctId': 'NCT03150758', 'briefTitle': 'Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Intra-operative Assessment of Cavernosal Nerve Stimulus Threshold', 'orgStudyIdInfo': {'id': 'CASE1816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical Stimulation', 'description': 'Each participant will be given 4 electrical stimulants with an amplitude ranging from 1mA to 30mA. The maximum stimulus without causing an erection will be recorded', 'interventionNames': ['Device: 10Hz + 100 micro-seconds', 'Device: 10Hz + 200 micro-seconds', 'Device: 7Hz + 100 micro-seconds', 'Device: 7Hz + 200 micro-seconds']}], 'interventions': [{'name': '10Hz + 100 micro-seconds', 'type': 'DEVICE', 'description': '10Hz Electrical Stimulation with a pulse width of 100 micro-seconds', 'armGroupLabels': ['Electrical Stimulation']}, {'name': '10Hz + 200 micro-seconds', 'type': 'DEVICE', 'description': '10Hz Electrical Stimulation with a pulse width of 200 micro-seconds', 'armGroupLabels': ['Electrical Stimulation']}, {'name': '7Hz + 100 micro-seconds', 'type': 'DEVICE', 'description': '7Hz Electrical Stimulation with a pulse width of 100 micro-seconds', 'armGroupLabels': ['Electrical Stimulation']}, {'name': '7Hz + 200 micro-seconds', 'type': 'DEVICE', 'description': '7Hz Electrical Stimulation with a pulse width of 200 micro-seconds', 'armGroupLabels': ['Electrical Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Eric Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}