Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT01023269
Status:
TERMINATED
Last Update Posted:
2019-01-31
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alexandra.delacour@medtronic.com', 'phone': '0041218027622', 'title': 'Alexandra Delacour, Clinical Research Manager', 'organization': 'Medtronic International Trading Sarl'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Patients', 'description': 'Adverse events in this study were reported on the 17 enrolled patients. Due to the small number of patients in each group, the summary on adverse events was provided for the combined groups.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'URINARY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain after surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Battery empty at 07h30 and return of symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead cut by the nurse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infection of the device stimulator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Bladder Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Randomized Patients', 'description': 'All randomized patients have been used for the primary objective. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.\n\nCombined groups:\n\n* group ON/OFF :Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks\n* group OFF/ON: Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '186.02', 'spread': '38.15', 'groupId': 'OG000'}]}]}, {'title': '4 weeks after impalnt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '367.16', 'spread': '201.17', 'groupId': 'OG000'}]}]}, {'title': '8 weeks after implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '346.07', 'spread': '177.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks after implant, 8 weeks after implant', 'description': "Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.", 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ON / OFF', 'description': 'Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.\n\nInterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.'}, {'id': 'FG001', 'title': 'OFF / ON', 'description': 'Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.\n\nInterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'early termination of the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '17 patients were included in the study: 9 patients did not pass the test stimulation period, 1 patient dropped out due to exclusion criteria, 1 patient dropped out due to protocol deviation during screening visit, 1 patient dropped out before test stimulation due to early termination of the study, leaving 5 patients who were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Patient', 'description': 'The patient demographic were analysed without splitting by study intervention since all randomized subjects were to receive both stimulation options (ie, ON and OFF)."'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.60', 'spread': '14.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The analysis was based on all randomized patients in the study. Due to early termination of the study, only 17 patients have been enrolled versus 78 planned enrolled patients. No analysis was done comparing the functional bladder capacity between the two intervention groups due to the low patient numbers in each group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'difficulty in the enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Bladder Capacity', 'timeFrame': 'Baseline, 4 weeks after implant, 8 weeks after implant', 'description': "Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neurogenic overactive bladder', 'Urinary incontinence due to incomplete spinal cord injury', 'Neuromodulation', 'Neuromodulation for treatment of neurogenic overactive bladder', 'Patients with Urge urinary incontinence and detrusor overactivity'], 'conditions': ['Neurogenic Overactive Bladder', 'Urinary Incontinence', 'Detrusor Overactivity']}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.', 'detailedDescription': 'The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.\n\nThis trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incomplete upper motor neuron lesion\n* Detrusor overactivity\n* Two leaks or two notices of leaks per day\n* Mean functional bladder capacity (volume voided per episode) of ≥100 ml\n\nExclusion Criteria:\n\n* Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.\n* Degenerative disease of the central nervous system'}, 'identificationModule': {'nctId': 'NCT01023269', 'acronym': 'ACCEPTANCE', 'briefTitle': 'Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder', 'orgStudyIdInfo': {'id': '1.02.7004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ON / OFF', 'description': 'Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.', 'interventionNames': ['Device: InterStim Therapy']}, {'type': 'OTHER', 'label': 'OFF / ON', 'description': 'Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.', 'interventionNames': ['Device: InterStim Therapy']}], 'interventions': [{'name': 'InterStim Therapy', 'type': 'DEVICE', 'description': 'Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.', 'armGroupLabels': ['OFF / ON', 'ON / OFF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Lyon-Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44627', 'city': 'Herne', 'country': 'Germany', 'facility': 'Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Klinik für Urologie Oberarzt-Sekretaria', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': "Niguarda Ospedale Ca' Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'National Hospital for Neurology and Neurosurgery', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michele Spinelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale Niguarda Ca' Granda, Milan, Italy"}, {'name': 'Karel Everaert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}, {'name': 'Philip Van Kerrebroeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Ziekenhuis, Maastricht, The Netherlands'}, {'name': 'Emmanuel Chartier-Kastler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Pitié Salpétrière, Paris, France'}, {'name': 'Arndt Van Ophoven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany'}, {'name': 'Karl Sievert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany'}, {'name': 'Suzy Elneil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Hospital for Neurology and Neurosurgery, London, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}