Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02092558
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D006417', 'term': 'Hematuria'}, {'id': 'D008679', 'term': 'Metaplasia'}], 'ancestors': [{'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': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097909', 'term': 'Second Generation Cephalosporins'}, {'id': 'D009582', 'term': 'Nitrofurantoin'}, {'id': 'D002511', 'term': 'Cephalosporins'}], 'ancestors': [{'id': 'D000097902', 'term': 'beta Lactam Antibiotics'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways", 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metaplasia, dysfunction, urinary bladder, children'], 'conditions': ['The Follow-up Duration Was 1-8 Years.', 'The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,', 'Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,', "Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary", 'System and Hematuria.']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oil.org.pl/xml/oil/oil68/tematy/komisje/stale/bioetyki', 'label': 'Bioethics Commitee in Warsaw'}]}, 'descriptionModule': {'briefSummary': 'Background: Squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (N-KSM).\n\nObjective: To present the investigators experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children.', 'detailedDescription': 'Design, setting, and participants: In this study, the investigators present their experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children aged from 5 to 17 years. From 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys. The reasons behind visiting the hospital were non-specific intense pain in the abdomen, recurrent urinary tract infections, and urination disorders. The most common symptoms of urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and retention of urine (reduced detrusor muscle activity).\n\nOutcome measurements and statistical analysis: In 20 patients (16.8%), metaplasia was incidentally diagnosed during cystoscopy performed for other causes. Only the children whose bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for collecting specimens for further histopathological examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In all, 119 children (116 girls and 3 boys), aged between 5 and 17 years (mean age, 13.7 years), who were treated in the Pediatric Surgery Department during the period of 2005-2013 were included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The follow-up duration was 1-8 years.\n* The main reasons behind visiting the hospital were:\n\n 1. recurrent urinary tract infection,\n 2. urinary urgencies,\n 3. pollakiuria,\n 4. difficulty in initiating micturition,\n 5. pain in hypogastrium,\n 6. night wetting and day wetting,\n 7. menstruation's disorders,\n 8. urolithiasis,\n 9. defects of urinary system and hematuria.\n\nExclusion Criteria:\n\n* No confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy"}, 'identificationModule': {'nctId': 'NCT02092558', 'briefTitle': 'Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital, Dziekanów Leśny, Poland"}, 'orgStudyIdInfo': {'id': 'KB/677/09'}, 'secondaryIdInfos': [{'id': 'Bioethics Commitee of Regional', 'type': 'REGISTRY', 'domain': 'KB/677/09'}, {'id': 'KB/677/09'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female 1', 'description': 'Owing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months.', 'interventionNames': ['Drug: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution']}, {'label': 'Male 2', 'description': 'Owing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months.', 'interventionNames': ['Drug: cephalosporin with chemotherapeutics']}], 'interventions': [{'name': 'Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution', 'type': 'DRUG', 'armGroupLabels': ['Female 1']}, {'name': 'cephalosporin with chemotherapeutics', 'type': 'DRUG', 'description': 'Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months', 'armGroupLabels': ['Male 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05-092', 'city': 'Dziekanów Lesny', 'country': 'Poland', 'facility': "Children's Hospital, Marii Konopnickiej Street 65"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital, Dziekanów Leśny, Poland", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD MD', 'investigatorFullName': 'Beata Jurkiewicz', 'investigatorAffiliation': "Children's Hospital, Dziekanów Leśny, Poland"}}}}