Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-31 @ 11:04 AM
Study NCT ID:
NCT03543995
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2018-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}, {'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D016136', 'term': 'Spina Bifida Occulta'}], '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'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dry bed days', 'timeFrame': '3 months', 'description': 'Patients were called for check-up one and three months later. When waking in the morning they were given a form to mark as dry or wet, and dry bed days were examined at check-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lower urinary tract symptoms', 'nocturnal enuresis', 'spina bifida occulta', 'treatment response'], 'conditions': ['Enuresis, Nocturnal', 'Spina Bifida']}, 'referencesModule': {'references': [{'pmid': '26149636', 'type': 'RESULT', 'citation': 'Kurt O, Yazici CM, Paketci C. Nocturnal enuresis with spina bifida occulta: Does it interfere behavioral management success? Int Urol Nephrol. 2015 Sep;47(9):1485-91. doi: 10.1007/s11255-015-1047-4. Epub 2015 Jul 7.'}, {'pmid': '25641449', 'type': 'RESULT', 'citation': 'Cakiroglu B, Tas T, Eyyupoglu SE, Hazar AI, Can Balci MB, Nas Y, Yilmazer F, Aksoy SH. The adverse influence of spina bifida occulta on the medical treatment outcome of primary monosymptomatic nocturnal enuresis. Arch Ital Urol Androl. 2014 Dec 30;86(4):270-3. doi: 10.4081/aiua.2014.4.270.'}, {'pmid': '17199857', 'type': 'RESULT', 'citation': 'Miyazato M, Sugaya K, Nishijima S, Owan T, Ogawa Y. Location of spina bifida occulta and ultrasonographic bladder abnormalities predict the outcome of treatment for primary nocturnal enuresis in children. Int J Urol. 2007 Jan;14(1):33-8. doi: 10.1111/j.1442-2042.2006.01666.x.'}]}, 'descriptionModule': {'briefSummary': 'It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients.\n\nThe present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 6 to 15 years who were admitted to an urology outpatient clinics with at least one night-time wetting weekly, were included in this prospective study.\n\nThe control group consisted of patients who were admitted to the urology outpatient clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination. The patients who were selected as the control group had night wetness questioned and the dysfunctional voiding symptom score (DVSS) form was completed. Those who had night wetting, neurological disease or diabetes mellitus were not included in the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 6 to 15 years\n* at least one night-time wetting weekly\n\nExclusion Criteria:\n\n* neurological disease,\n* diabetes mellitus or insipidus,\n* spinal surgery history, spina bifida skin findings,\n* chronic renal insufficiency\n* and secondary enuresis'}, 'identificationModule': {'nctId': 'NCT03543995', 'briefTitle': 'The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Training and Research Hospital'}, 'officialTitle': 'The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial', 'orgStudyIdInfo': {'id': '5520'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enuresis nocturna', 'description': 'Patients aged 6 to 15 years with at least one night-time wetting weekly'}, {'label': 'Normal population', 'description': 'Patients who were admitted to the urology clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammet Fatih Kilinc', 'investigatorAffiliation': 'Ankara Training and Research Hospital'}}}}