Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT03522818
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enuresis Alarm - Is a Manual Trigger System Beneficial?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-08', 'releaseDate': '2023-03-05'}, {'resetDate': '2025-09-02', 'releaseDate': '2025-08-13'}], 'estimatedResultsFirstSubmitDate': '2023-03-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-09-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the change and % reduction in mean number wet nights/week (>90%, 50-89%, <50%) of patients with treatment success with use of a manual trigger + moisture alarm vs. moisture alarm only', 'timeFrame': 'one year', 'description': 'Bladder Diary (Participant self-reported)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enuresis, Nocturnal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.', 'detailedDescription': 'Nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. However, use of alarms is very time-intensive, often taking months before yielding results. Researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.\n\nChildren between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.\n\nParticipants must first be evaluated by a pediatric urology specialist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children ages 5-15 years\n* Diagnosis of Primary Monosymptomatic Nocturnal Enuresis\n* \\>2 wet nights per week\n* Score of 7 or below on questions 1-6 and 9-13 on Vancouver Dysfunctional Elimination Questionnaire\n* Patients/parents compliance in recording data \\> 50% of nights\n\nExclusion Criteria:\n\n* Known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, VUR), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery\n* Concomitant DDAVP use, anticholinergic use, B3 agonist use'}, 'identificationModule': {'nctId': 'NCT03522818', 'briefTitle': 'Enuresis Alarm - Is a Manual Trigger System Beneficial?', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Enuresis Alarm - Is a Manual Trigger System Beneficial?', 'orgStudyIdInfo': {'id': '201801703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal', 'description': 'Group will use the alarm as provided by the manufacture.', 'interventionNames': ['Behavioral: Normal']}, {'type': 'EXPERIMENTAL', 'label': 'Manual trigger', 'description': 'Group will use the same model but will be instructed to manually trigger the alarm 1-2 hours after the child falls asleep.', 'interventionNames': ['Behavioral: Manual Trigger']}], 'interventions': [{'name': 'Manual Trigger', 'type': 'BEHAVIORAL', 'description': 'Will use the alarm as provided by the manufacture but parent has to manual trigger the alarm 1-2 hours after the child falls asleep.', 'armGroupLabels': ['Manual trigger']}, {'name': 'Normal', 'type': 'BEHAVIORAL', 'description': 'Will use the alarm as provided by the manufacture.', 'armGroupLabels': ['Normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gina Lockwood, MD, MS', 'role': 'CONTACT', 'email': 'gina-lockwood@uiowa.edu', 'phone': '319-353-8673'}, {'name': 'Denise Juhr, BS', 'role': 'CONTACT', 'email': 'denise-juhr@uiowa.edu', 'phone': '(319) 356-1111', 'phoneExt': 'Juhr'}, {'name': 'Gina Lockwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Gina M Lockwood, MD, MS', 'role': 'CONTACT', 'email': 'gina-lockwood@uiowa.edu', 'phone': '(319) 353-8673'}], 'overallOfficials': [{'name': 'Gina M Lockwood, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gina Lockwood', 'class': 'OTHER'}, 'collaborators': [{'name': 'PottyMD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor', 'investigatorFullName': 'Gina Lockwood', 'investigatorAffiliation': 'University of Iowa'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-05', 'type': 'RELEASE'}, {'date': '2023-12-08', 'type': 'RESET'}, {'date': '2025-08-13', 'type': 'RELEASE'}, {'date': '2025-09-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gina Lockwood, Principal Investigator, Medical Doctor, University of Iowa'}}}}