Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-02 @ 4:36 PM
Study NCT ID:
NCT04352257
Status:
UNKNOWN
Last Update Posted:
2020-04-20
First Post:
2020-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036761', 'term': 'Ultrasound, High-Intensity Focused, Transrectal'}], 'ancestors': [{'id': 'D057086', 'term': 'High-Intensity Focused Ultrasound Ablation'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2020-04-12', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pelvic and transrectal ultrasound', 'timeFrame': '18 months', 'description': 'bladder wall thickness, prostate volume, and prostate morphology'}], 'secondaryOutcomes': [{'measure': 'pelvic and transrectal ultrasound in relation to pressure flow study', 'timeFrame': '18 months', 'description': 'correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?', 'detailedDescription': 'Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient more than 50 year old who were presented with Lower urinary tract symptoms.The patients were be subjected to pelvic and transrectal ultrasound.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmale patients with LUTS/BPH prostate size \\> 25 g\n\nExclusion Criteria:\n\nurinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (\\< 150 ml) urethral stricture evident prostate carcinoma.'}, 'identificationModule': {'nctId': 'NCT04352257', 'briefTitle': 'Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Bladder and Prostate Sonomorphology as a Useful Tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'RS/19.21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ultrasonography', 'description': 'pelvic and transrectal ultrasound', 'interventionNames': ['Radiation: pelvic Ultrasound']}], 'interventions': [{'name': 'pelvic Ultrasound', 'type': 'RADIATION', 'otherNames': ['transrectal ultrasound'], 'description': 'pelvic and transrectal ultrasound', 'armGroupLabels': ['ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Diaa ELDIN Taha, MD', 'role': 'CONTACT', 'email': 'drdiaaeldin@gmail.com', 'phone': '01008531384'}], 'facility': 'Kafrelsheikh faculty of medicine', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Diaa Eldin Taha, MD', 'role': 'CONTACT', 'email': 'drdiaaeldin@gmail.com', 'phone': '01008531384'}], 'overallOfficials': [{'name': 'Diaa Eldin Taha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of urology', 'investigatorFullName': 'Diaa Eldin Taha Ramadan Mohamed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}