Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT03397368
Status:
UNKNOWN
Last Update Posted:
2019-08-06
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Transperineal US in Stress Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014563', 'term': 'Urodynamics'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '5 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-04', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants who will be properly diagnosed to have genuine stress incontinence To determine the role of transperineal ultrasound in diagnosing stress incontinence', 'timeFrame': 'within a week', 'description': 'the outcome describes how much the transperineal us have a power to diagnose stress incontinence in comparison to urodynamic study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Incontinence, Female']}, 'descriptionModule': {'briefSummary': 'Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified risk factors are aging, obesity and repeated pregnancies and deliveries.\n\nUrodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound appears to have a good role in diagnosing stress incontinence', 'detailedDescription': 'A comparative observational cross sectional study will be conducted .\n\nThe symptom, or "subjective indicator of disease," of SUI is described as "the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing." 1 Stress urinary incontinence (SUI) has an observed prevalence of between 4% and 35%.\n\nIt\'s a social problem that causes hygienic problem that s distressing for females.\n\nUrodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it\'s not done routinely in all cases of urinary incontinence according to the NICE guidelines 2 Translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'females who are complaining from stress incontinence that did urodynamics study and proved to have a genuine stress incontinence and referred to do transperineal ultrasound', 'genderDescription': 'females who are complaining from stress incontinence', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfemales between 20-75 years old\n\n* -Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic.\n\nExclusion Criteria:\n\n* -Known to be Diabetic\n* Urge incontinence or mixed type\n* Voiding dysfunction\n* Neurological problems\n* open suprapubic wound\n* Previous surgery for POP(pelvic organ prolapse) or incontinence\n* suspicion of pelvic malignancy'}, 'identificationModule': {'nctId': 'NCT03397368', 'briefTitle': 'Evaluation of Transperineal US in Stress Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Evaluation of Role of Transperineal US in Differentiating Degrees of Genuine Stress Incontinence in Females Diagnosed by Urodynamics', 'orgStudyIdInfo': {'id': 'stress incontinence'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transperineal Ultrasound -', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Urodynamics'], 'description': 'Every women with stress incontinence witll be subjected to urodynamics to confirm genuine stress incontinence then will be subjected Transperineal US'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed el lithy, M.D', 'role': 'CONTACT', 'email': 'ahmedellithy75@gmail.com', 'phone': '01120205000'}], 'facility': 'Kasralainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mahmoud Alalfy, M.s.c', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Ellithy, M.D', 'role': 'CONTACT', 'email': 'ahmedellithy75@gmail.com', 'phone': '+201120205000'}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, M.s.c', 'role': 'STUDY_CHAIR', 'affiliation': 'Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital', 'investigatorFullName': 'Mahmoud Alalfy', 'investigatorAffiliation': 'Aljazeera Hospital'}}}}