Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01972061
Status:
TERMINATED
Last Update Posted:
2020-02-26
First Post:
2013-10-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'chermanskycj2@upmc.edu', 'phone': '412-6418385', 'title': 'Dr. Christopher Chermansky', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The 3 hour hand group was not started or completed due to lack of funding.'}}, 'adverseEventsModule': {'timeFrame': '3 Weeks at the individual participant level.', 'description': 'Adverse events were tracked from the time of consent until study completion. The study team followed the data safety and monitoring plan outlined in the protocol. The Principal Investigator and study team reviewed the data at regular intervals to assess, record and report any Adverse Events or Serious Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'CMG Group', 'description': 'Foot stimulation will be applied during a cystometrogram (CMG).\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Urinary Incontinence Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'OG001', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.', 'unitOfMeasure': 'Urinary Incontinence Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Urinary Urgency Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'OG001', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '7.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary urgency episodes was calculated for week 1 and week 2 for each subject.', 'unitOfMeasure': 'Urinary urgency episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bladder Volume as Recorded on CMG for Strong Desire to Void', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CMG Group', 'description': 'Foot stimulation will be applied during a cystometrogram (CMG).\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}], 'classes': [{'title': 'CMG#1 Baseline', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}]}]}, {'title': 'CMG #2 Foot Stimulation', 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'CMG #1 and CMG#2', 'description': 'Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation', 'unitOfMeasure': 'ml', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Urinary Voids Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'OG001', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '7.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '7.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)', 'unitOfMeasure': 'urinary voids per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CMG Group', 'description': 'Foot stimulation will be applied during a cystometrogram (CMG).\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'FG001', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'FG002', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CMG Group', 'description': 'Foot stimulation will be applied during a cystometrogram (CMG).\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'BG001', 'title': '3 Hours Group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'BG002', 'title': '1/2 Hour Group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.\n\nFoot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The funding was not available to complete the 3 hour hand group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-01', 'size': 2365385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-21T12:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Lack of continued funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2013-10-18', 'resultsFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-14', 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bladder Volume as Recorded on CMG for Strong Desire to Void', 'timeFrame': 'CMG #1 and CMG#2', 'description': 'Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation'}, {'measure': 'Number of Urinary Voids Per Day', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)'}], 'primaryOutcomes': [{'measure': 'Number of Urinary Incontinence Episodes Per Day', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.'}], 'secondaryOutcomes': [{'measure': 'Number of Urinary Urgency Episodes Per Day', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary urgency episodes was calculated for week 1 and week 2 for each subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.', 'detailedDescription': 'Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 year old men and women and older\n2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence\n3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB\n\nExclusion Criteria:\n\n1. Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.\n2. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.\n3. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.'}, 'identificationModule': {'nctId': 'NCT01972061', 'acronym': 'FootStim', 'briefTitle': 'Foot/Hand Neuromodulation for Overactive Bladder (OAB)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Foot/Hand Neuromodulation for Overactive Bladder (OAB)', 'orgStudyIdInfo': {'id': 'PRO13020474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMG group', 'description': 'Foot stimulation will be applied during a cystometrogram (CMG).', 'interventionNames': ['Device: Foot stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 hours group', 'description': 'Foot stimulation will be applied daily for 3 hours in the evening.', 'interventionNames': ['Device: Foot stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1/2 hour group', 'description': 'Foot stimulation will be applied daily for 1/2 hour in the evening.', 'interventionNames': ['Device: Foot stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 hour hand group', 'description': 'Hand stimulation will be applied daily for 3 hours in the evening.', 'interventionNames': ['Device: Foot stimulation']}], 'interventions': [{'name': 'Foot stimulation', 'type': 'DEVICE', 'description': 'Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.', 'armGroupLabels': ['1/2 hour group', '3 hour hand group', '3 hours group', 'CMG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Christopher Chermansky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Dawn McBride, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher J Chermansky, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Urology', 'investigatorFullName': 'Christopher J Chermansky, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}