Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-29 @ 6:50 PM
Study NCT ID:
NCT02930720
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Displacement in Women With SUI and Healthy Women: An Ultrasound Study (Stress Urinary Incontinence)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D003371', 'term': 'Cough'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-11', 'lastUpdatePostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pelvic floor displacement', 'timeFrame': '20-30 minutes', 'description': 'in mm'}], 'secondaryOutcomes': [{'measure': 'Incontinence Quality of Life (I-QOL)', 'timeFrame': '5 minutes', 'description': 'score of questionaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TAUS', 'breathing protocols and cough', 'pelvic floor displacement', 'women', 'SUI'], 'conditions': ['Healthy', 'Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about 25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and obstetric history. SUI is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.', 'detailedDescription': '50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (TAUS) examination. the research group participants will be asked to fill a quality of life questionaire concerning their SUI complaint.\n\nat the TAUS examination the participant will be asked to perform:\n\n1. 3 times quiet breathing.\n2. 3 times forced exhalation.\n3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "50 parous women, who performed one vaginal delivey. age 25-50. all women are 'macabi medical services' members. 25 women who complain about stress urinary incontinence. 25 healthy women.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women after one vaginal delivery on term.\n* women aged 25-50\n* members of 'macabi medical services'\n\nExclusion Criteria:\n\n* pregnancy\n* nulliparous women\n* women who had C section delivery\n* known neurologic disease\n* previous history of pelvic or back surgery\n* previous history of pelvic fracture\n* known pulmonary disease\n* active urinary tract infection"}, 'identificationModule': {'nctId': 'NCT02930720', 'acronym': 'SUI', 'briefTitle': 'Pelvic Floor Displacement in Women With SUI and Healthy Women: An Ultrasound Study (Stress Urinary Incontinence)', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Hospital Systems'}, 'officialTitle': 'The Influence of Various Breathing Protocols and Cough on the Amount of Pelvic Floor Displacement in Women With Stress Urinary Incontinence and Healthy Women: An Ultrasound Study', 'orgStudyIdInfo': {'id': 'AssutaHS0087-16'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Macabi hadar yossef', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Iris Sinai, Bpt', 'role': 'CONTACT', 'email': 'Irisinai31@gmail.com', 'phone': '972-54-4468327'}, {'name': 'Vered Eisenberg, Md', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Hospital Systems', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Iris sinai', 'investigatorAffiliation': 'Assuta Hospital Systems'}}}}