Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03614767
Status:
UNKNOWN
Last Update Posted:
2019-10-15
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacral Neuromodulation & Urodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014563', 'term': 'Urodynamics'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-13', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bladder volume', 'timeFrame': '3 weeks', 'description': 'Change in bladder volume is measured before and after test procedure for sacral neuromodulation'}, {'measure': 'Change in bladder sensation', 'timeFrame': '3 weeks', 'description': 'Bladder sensation is measured by a slider (indicating bladder fullness scaled from 0 to 100) before and after test procedure for sacral neuromodulation'}, {'measure': 'Change in ice water test', 'timeFrame': '3 weeks', 'description': 'Ice water is infused in the bladder and incontinence upon insertion of the ice water is assessed before and after sacral neuromodulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder', 'Non-obstructive Urinary Retention']}, 'descriptionModule': {'briefSummary': 'In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).\n\nLong-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with overactive bladder or non-obstructive urinary retention.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overactive bladder\n* Non-obstructive urinary retention\n\nExclusion Criteria:\n\n* Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)'}, 'identificationModule': {'nctId': 'NCT03614767', 'briefTitle': 'Sacral Neuromodulation & Urodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients', 'orgStudyIdInfo': {'id': '17/30334'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Successes', 'description': 'Patients with \\>50% improvement during test procedure of sacral neuromodulation.', 'interventionNames': ['Diagnostic Test: urodynamics']}, {'label': 'Failures', 'description': 'Patients with \\<50% improvement during test procedure of sacral neuromodulation.', 'interventionNames': ['Diagnostic Test: urodynamics']}], 'interventions': [{'name': 'urodynamics', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Ice water test', 'Slider'], 'description': 'Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.', 'armGroupLabels': ['Failures', 'Successes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'state': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Stefan De Wachter, MD PhD FEBU', 'role': 'CONTACT'}], 'facility': 'University of antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'centralContacts': [{'name': 'Stefan De Wachter, MD PhD FEBU', 'role': 'CONTACT', 'email': 'stefan.dewachter@antwerpen.be', 'phone': '8215934', 'phoneExt': '323'}], 'overallOfficials': [{'name': 'Stefan De Wachter, MD PhD FEBU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Donald Vaganée', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}