Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05845320
Status:
UNKNOWN
Last Update Posted:
2023-05-30
First Post:
2023-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women', 'timeFrame': '6 months', 'description': 'as detected by questionnaire score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Female urinary continence is maintained through an integrated function of pelvic floor muscles (PFMs), fascial structures, nerves, supporting ligaments, and the vagina. In women with SUI, the postural activity of the PFMs is delayed, and the balance ability is decreased. Many women, by learning the correct timing of a pelvic floor contraction during a cough, are able to eliminate consequent SUI. Timing is an important function of motor coordination and could be affected by proprioception.\n\nWe aim to assess stress urinary incontinence in obese and non-obese Nulligravid females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy nulligravid females', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between18 and 45 years.\n* Non obese females with BMI \\<25kg/m2.\n* Obese females with BMI ≥30kg/m2.\n* Nulligravid females.\n\nExclusion Criteria:\n\n* Multiparous Females\n* Patients with active urinary tract infection.\n* Patients with respiratory or neurological diseases.\n* Patients with communication problems, cognitive disorders \\& mental disturbance.\n* Current treatment with drugs (benzodiazepines, diuretics)\n* Patients who underwent any previous abdominal or pelvic surgery.'}, 'identificationModule': {'nctId': 'NCT05845320', 'briefTitle': 'Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women', 'orgStudyIdInfo': {'id': 'MS 188/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'BMI\\>30', 'interventionNames': ['Other: ICIQ-UI SF questionnaire']}, {'label': 'Non-obesse', 'description': 'BMI\\<25', 'interventionNames': ['Other: ICIQ-UI SF questionnaire']}], 'interventions': [{'name': 'ICIQ-UI SF questionnaire', 'type': 'OTHER', 'description': 'validated arabic short form of ICIQ on urinary incontinence', 'armGroupLabels': ['Non-obesse', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo/القاهرة', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maii Nawara, MD', 'role': 'CONTACT', 'email': 'maii_nawara@hotmail.com', 'phone': '01001848388'}], 'facility': 'Ain Shams University maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maii Nawara', 'role': 'CONTACT', 'email': 'maii_nawara@hotmail.com', 'phone': '+201001848388'}], 'overallOfficials': [{'name': 'Maii Nawara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'all data will be available with principal investigator upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}