Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 7:50 AM
Study NCT ID:
NCT06285006
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of episodes per week after desmopressin treatment', 'timeFrame': 'After the end of the treatment for one month.', 'description': 'Patients will be evaluate by no. of episodes per week after desmopressin treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nocturnal enuresis', 'Desmopressin', 'Monotherapy'], 'conditions': ['Nocturnal Enuresis']}, 'descriptionModule': {'briefSummary': 'Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.\n\nNE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* School age group (from 7 to 14 years)\n* Primary monosymptomatic nocturnal enuresis\n\nExclusion Criteria:\n\nPatients with one or more of the following will be excluded from the study.\n\n* Diurnal enuresis\n* Urinary tract infection within the preceding 3 months\n* Diabetes mellitus\n* History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.\n* Post-micturition residual urine \\>1/3 expected bladder capacity.\n* Each patient will be subjected to the following.'}, 'identificationModule': {'nctId': 'NCT06285006', 'briefTitle': 'Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis', 'orgStudyIdInfo': {'id': 'MScAZASTPED025/23/202/12/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desmopressin', 'description': 'Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules.', 'interventionNames': ['Drug: Desmopressin']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'description': 'Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules.', 'armGroupLabels': ['Desmopressin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11884', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omnia Nassar, Dr', 'role': 'CONTACT', 'email': 'omnianassar835@gmail.com', 'phone': '01010112054'}, {'name': 'Hosny Elmasry, Prof', 'role': 'CONTACT', 'email': 'omnianassar835@gmail.com', 'phone': '01010112054'}], 'facility': 'Alazhar university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Omnia Nassar, Dr', 'role': 'CONTACT', 'email': 'omnianassar835@gmail.com', 'phone': '01010112054'}, {'name': 'Hosny Elmasry, Prof', 'role': 'CONTACT', 'email': 'omnianassar835@gmail.com', 'phone': '01010112054'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hosny Mohamed Ahmed Elmasry', 'investigatorAffiliation': 'Al-Azhar University'}}}}