Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT04429360
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Effect of Prolapse Surgery on Voiding?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 453}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lower urinary tract symptoms pre- postoperatively', 'timeFrame': '1 year follow-up', 'description': 'Voiding diary'}, {'measure': 'Change in lower urinary tract symptoms pre- postoperatively', 'timeFrame': '1 year follow-up', 'description': 'Questionnaire: PFDI-20'}], 'secondaryOutcomes': [{'measure': 'Change in clinical outcome measures', 'timeFrame': '1 year follow-up', 'description': 'POP-Q'}, {'measure': 'Change in clinical outcome measures', 'timeFrame': '1 year follow-up', 'description': 'Transperineal ultrasound (TPUS)'}, {'measure': 'Change in voiding', 'timeFrame': '1 year follow-up', 'description': 'home-uroflowmetry'}, {'measure': 'Change in QoL', 'timeFrame': '1 year follow-up', 'description': 'Questionnaire: PFIQ-7'}, {'measure': 'Change in QoL', 'timeFrame': '1 year follow-up', 'description': 'Questionnaire: PISQ-12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic Organ Prolapse', 'Surgery', '3D/4D imaging', 'urinary incontinence', 'voiding dysfunction', 'patient reported outcome'], 'conditions': ['Pelvic Organ Prolapse', 'Stress Urinary Incontinence', 'Overactive Bladder', 'Voiding Disorders', 'Urge Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women attending a gynecological unit with symptoms of pelvic organ prolapse and who will undergo pelvic floor surgery as management of their symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* Dutch, French or English- speaking women\n* symptoms of pelvic organ prolapse\n* preoperatively pelvic floor surgery.\n\nExclusion Criteria:\n\n\\- history of neurological disease'}, 'identificationModule': {'nctId': 'NCT04429360', 'acronym': 'PROVOID', 'briefTitle': 'What is the Effect of Prolapse Surgery on Voiding?', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'What is the Effect of Prolapse Surgery on Voiding?', 'orgStudyIdInfo': {'id': 'EDGE000835'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pelvic reconstructive surgery', 'type': 'PROCEDURE', 'description': 'Pelvic reconstructive surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sascha Vereeck, Dr.', 'role': 'CONTACT', 'email': 'saschavereeck@hotmail.com', 'phone': '003238215945'}], 'facility': 'University Hospital of Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Sascha Vereeck, Dr.', 'role': 'CONTACT', 'email': 'saschavereeck@hotmail.com', 'phone': '003238215945'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department Gynecology, UZA', 'investigatorFullName': 'Prof Yves Jacquemyn', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}