Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT04835766
Status:
UNKNOWN
Last Update Posted:
2023-11-27
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urodynamic Changes Following Bladder Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder dysfunction', 'timeFrame': '6 months', 'description': 'Uroflowmerty measuring the flow of urine in ml per minute'}, {'measure': 'Residual urine volume', 'timeFrame': '6 months', 'description': 'Assessed by ultrasound to measure volume of residual urine'}, {'measure': 'maximum flow rate', 'timeFrame': '6 months', 'description': 'Urodynamic study'}, {'measure': 'Detrusor pressure at maximum flow', 'timeFrame': '6 months', 'description': 'Urodynamic study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urologic Injuries', 'Urodynamic Changes', 'Bladder Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study.', 'detailedDescription': 'Patients will be initially assessed by overactive bladder (OAB) and incontinence questionnaire. Examination was done to determine any neurological, or congenital abnormalities.\n\nUrodynamic study (UDS) will done for all patients. The patients will be asked to drink fluids to obtain a comfortably full bladder. Initially, a pelvic-abdominal ultrasound was done followed by the UDS. Urodynamic study consisted of uroflowmetry (volume: ≥150 ml and Qmax: 20-30 ml/s); filling cystometry in physiological or medium filling rate of 40 ml/min (using normal saline at room temperature through a double lumen urethral catheter); stress leak test; and pressure flow study.\n\nNo sedation will be administered during the study as the patient should be aware. The patients were placed in a semi-seated lithotomy position. After a detailed explanation to the patient, the examination will begin by passing a catheter into the bladder (5 Fr) to measure the postvoiding residual urine followed by filling the bladder and measuring the intravesical pressure through the catheter.\n\nA rectal catheter was placed for measuring the abdominal pressure. The systems will be always zeroed at the atmospheric pressure. The patients will be periodically asked to cough to check the operation of the equipment and instructed to report her sensations.\n\nThe volume of the first sensation of filling, first desire (1 s) and second desire (2 s) were recorded. When the bladder was filled up to 150 ml, patients were asked to cough (Valsalva) to predict the stress leakage. If not occur at 150 ml, the bladder was refilled, and the stress test was repeated until the leakage occurred or the bladder capacity was reached. Additionally, any unidentified involuntary detrusor contractions will be noted.\n\nWhen the patient had the urge to void, the permission for voiding will be given. Then voiding cystometrogram (pressure-flow) was performed and the urodynamic parameters, such as maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax) will be observed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is multi-center descriptive cohort study. This study will be conducted at Urology departments. Cases were recruited from both Obstetrics and gynecology and Urology departments of Al-Azhar University and Tanta University. All cases had past history of bladder injury during PAS surgery either by hysterectomy or uterine sparing techniques.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-40 years\n* Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment\n* Bladder injury was diagnosed and repaired during surgery 6 months ago.\n\nExclusion Criteria:\n\n* Patients with neurological problems\n* Presence of congenital urinary system anomalies\n* Urinary tract infections (UTIs)\n* Previous urologic surgeries\n* Patients with stone bladder or tumour\n* Diabetic patients'}, 'identificationModule': {'nctId': 'NCT04835766', 'acronym': 'Uro-PAS', 'briefTitle': 'Urodynamic Changes Following Bladder Injury', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study', 'orgStudyIdInfo': {'id': 'Uro-PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptomatic group', 'description': 'These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms', 'interventionNames': ['Diagnostic Test: Urodynamic study']}, {'label': 'Asymptomatic group', 'description': 'These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms', 'interventionNames': ['Diagnostic Test: Urodynamic study']}], 'interventions': [{'name': 'Urodynamic study', 'type': 'DIAGNOSTIC_TEST', 'description': 'Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).', 'armGroupLabels': ['Asymptomatic group', 'Symptomatic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Algharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Salah Zeidan, MD', 'role': 'CONTACT', 'email': 'salahshebl@gmail.com', 'phone': '+201020972067'}, {'name': 'Ayman Dawood, MD', 'role': 'CONTACT', 'email': 'ayman.dawood@med.tanta.edu.eg', 'phone': '+201020972067'}], 'facility': 'Ayman Shehata Dawood', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Ayman Dawoog, MD', 'role': 'CONTACT', 'email': 'ayman.dawood@med.tanta.edu.eg', 'phone': '+202020972067'}, {'name': 'Ayman Dawood, MD', 'role': 'CONTACT', 'email': 'ayman.dawood@med.tanta.edu.eg', 'phone': '+201020972067'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'description': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}