Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-11 @ 6:49 AM
Study NCT ID:
NCT04525105
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2020-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SMAD2', 'timeFrame': 'intraoperative', 'description': 'tissue expression and protein level'}, {'measure': 'SMAD3', 'timeFrame': 'intraoperative', 'description': 'tissue expression and protein level'}, {'measure': 'TGF-ß1 mRNA Expression Levels', 'timeFrame': 'intraoperative', 'description': 'tissue expression and protein level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SMAD2', 'SMAD3', 'TGF-β', 'Pelvic Organ Prolapse', 'Urge Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '33599951', 'type': 'DERIVED', 'citation': 'Akin MN, Sivaslioglu AA, Edgunlu T, Kasap B, Celik SK. SMAD2, SMAD3 and TGF-beta GENE expressions in women suffering from urge urinary incontinence and pelvic organ prolapse. Mol Biol Rep. 2021 Feb;48(2):1401-1407. doi: 10.1007/s11033-021-06220-4. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.', 'detailedDescription': 'This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who had been diagnosed with POP and UUI and asymptomatic women without complaints of POP and UUI', 'genderDescription': '\\> 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who had been diagnosed with POP and UUI\n* asymptomatic women without complaints of POP and UUI\n\nExclusion Criteria:\n\n* Women who have SUI,\n* a history of gynecologic malignancy,\n* endometriosis,\n* connective tissue disorders,\n* asthma,\n* previous pelvic inflammatory disease,\n* pelvic radiation anamnesis,\n* smoking,\n* previous surgery for POP or UI,\n* those on steroid therapy and hormone replacement therapy'}, 'identificationModule': {'nctId': 'NCT04525105', 'briefTitle': 'SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?', 'orgStudyIdInfo': {'id': '18/II/26.10.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'wıth URGE INCONTINANCE', 'interventionNames': ['Genetic: SMAD2']}, {'label': 'Control group', 'description': 'not urge incontinance', 'interventionNames': ['Genetic: SMAD2']}], 'interventions': [{'name': 'SMAD2', 'type': 'GENETIC', 'otherNames': ['SMAD3', 'TGF-β1'], 'description': 'a family of structurally related cytokines', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sıtkı Kocman University Faculty of Medicine', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If anyone demand the results of our study, we can share data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Melike Nur Akın', 'investigatorFullName': 'Melike Nur AKIN', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}