Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 11:57 AM
Study NCT ID:
NCT03386292
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2017-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary and Anal Incontinence in Tunisian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2017-12-16', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of urinary incontinence', 'timeFrame': '1 month', 'description': 'The participant will be asked to fill out the urinary symptom profile questionnaire (USP). This questionnaire contains 13 items to assess stress urinary incontinence, urge urinary incontinence and dysuria. Each question is scored from 0 to 3 providing a maximal score of 9, 21 and 9 for stress urinary incontinence, urge urinary incontinence and dysuria respectively. Women diagnosed with both stress and urge urinary incontinence by the USP were classified as having mixed urinary incontinence.'}, {'measure': 'Prevalence of anal incontinence', 'timeFrame': '1 month', 'description': 'The participant will be asked to fill out the anal incontinence Jorge and Wexner which contains five questions scored on a scale from zero (normal continence) to 20 (total incontinence).'}], 'secondaryOutcomes': [{'measure': 'Risk factors for urinary and anal incontinence', 'timeFrame': '1 month'}]}, 'conditionsModule': {'keywords': ['prevalence', 'urinary incontinence', 'anal incontinence', 'risk factors', 'women'], 'conditions': ['Woman']}, 'descriptionModule': {'briefSummary': 'The publications on prevalence and risk factors of urinary and anal incontinence in women were performed mainly in Europe and America. Consequently, result extrapolation to Tunisian population may not be a good practice which justifies this study and demonstrates its importance.', 'detailedDescription': 'A cross-sectional study will be conducted among female doctors and nurses randomly selected from 3 large hospitals in the center of Tunisia. The prevalence of urinary incontinence and anal incontinence will be measured using validated questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female doctors and nurses working at Sahloul Hospital, Taher Sfar Hospital and Fattouma Bourguiba Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Professional seniority in the current service over than 6 months\n* Subject has given his consent\n\nExclusion Criteria:\n\n* Resident\n* Intern\n* An ongoing pregnancy\n* A recent birth (less than 6 months)\n* A psychiatric disease\n* An acute or chronic kidney disease\n* Neurological disease'}, 'identificationModule': {'nctId': 'NCT03386292', 'briefTitle': 'Urinary and Anal Incontinence in Tunisian Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Prevalence and Risk Factors for Urinary and Anal Incontinence in Tunisian Middle Aged Women', 'orgStudyIdInfo': {'id': 'Monastir University'}}, 'contactsLocationsModule': {'locations': [{'zip': '5019', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Faculty of Medecine', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Syrine GALLAS', 'investigatorAffiliation': 'University of Monastir'}}}}