Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT04300400
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of the Overactive Bladder Syndrome: A Delphi Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of consensus on the level of appropriateness', 'timeFrame': '8 months', 'description': 'No consensus, trend towards consensus or consensus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive bladder Syndrome', 'Delphi study', 'Treatment algorithm'], 'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.', 'detailedDescription': 'Guidelines on the overactive bladder syndrome (European Association of Urology, American Urology Association and International Consultation on Incontinence) are comparable but remain vague mainly on the level between conservative and major surgery. They do not specify combinations of medications and do not distinguish between intradetrusor botulinum toxin injections (BTX) and sacral neuromodulation (SNM) because of lack of evidence.\n\nTo reduce the variability in the treatment management of OAB, standardization is needed.\n\nBy use of a Delphi technique, the current perception of Belgian urologists towards the most appropriate treatment approach for idiopathic OAB (iOAB) was explored.\n\nBased on these results a practical treatment algorithm for its use in daily clinical practice could be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Belgian Urologists: members of the working group of Functional Urology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Profession: MD, Urologist\n* Member of the working group of Functional Urology\n\nExclusion Criteria:\n\n* Retirement\n* Non-operative as an urologist.'}, 'identificationModule': {'nctId': 'NCT04300400', 'briefTitle': 'Treatment of the Overactive Bladder Syndrome: A Delphi Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Development of a Flowchart Reflecting the Current Attitude and Approach Towards the Idiopathic Overactive Bladder Treatment in Belgium: A Delphi Study', 'orgStudyIdInfo': {'id': 'B670201835542'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Delphi panel', 'description': 'Urologists of the Belgian Working group of Functional Urology willing to participate on the Delphi project.', 'interventionNames': ['Other: Delphi questionnaire']}], 'interventions': [{'name': 'Delphi questionnaire', 'type': 'OTHER', 'description': 'Statements on OAB topics, rated along their level of appropriateness on a scale from 1 to 9. Multiple rounds are organised to reach consensus on a topic.', 'armGroupLabels': ['Delphi panel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Lynn Ghijselings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}