Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT02315560
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Foot Neuromodulation for Nocturnal Enuresis
Sponsor:
Organization:
Raw JSON
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This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit\n\nTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decrease in Nocturnal Enuresis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Stimulation', 'description': 'The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit\n\nTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Stimulation', 'description': 'The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit\n\nTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children'}], 'classes': [{'title': 'Pre-stimulation', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '35'}]}]}, {'title': 'Stimulation', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '33'}]}]}, {'title': 'Post-stimulation', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tibial Nerve Stimulation', 'description': 'The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit\n\nTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'noncompliance by subjects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tibial Nerve Stimulation', 'description': 'The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit\n\nTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-01', 'size': 1265540, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-01T08:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2014-12-09', 'resultsFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-14', 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in Nocturnal Enuresis', 'timeFrame': '6 weeks', 'description': 'To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Questionnaire Scores', 'timeFrame': '6 weeks', 'description': 'The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bedwetting'], 'conditions': ['Bedwetting']}, 'descriptionModule': {'briefSummary': 'To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children', 'detailedDescription': "Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history\n2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence\n3. Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants\n4. Having been assessed for and treated if applicable for constipation\n\nExclusion Criteria:\n\n1. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes\n2. Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants\n3. Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.\n4. Children who are not adequately potty trained\n5. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence\n\n5\\. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment\n\n6\\. Children with any implantable medical devices such as a pacemaker will be excluded from the study\n\nNote: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.'}, 'identificationModule': {'nctId': 'NCT02315560', 'briefTitle': 'Foot Neuromodulation for Nocturnal Enuresis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Foot Neuromodulation for Nocturnal Enuresis in Children', 'orgStudyIdInfo': {'id': 'PRO14080250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tibial Nerve Stimulation', 'description': 'The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit', 'interventionNames': ['Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS']}], 'interventions': [{'name': 'TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS', 'type': 'DEVICE', 'description': 'electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children', 'armGroupLabels': ['Tibial Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh og UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidi Stephany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Heidi Stephany', 'investigatorAffiliation': 'University of Pittsburgh'}}}}