Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:56 PM
Study NCT ID:
NCT00937833
Status:
COMPLETED
Last Update Posted:
2014-12-29
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011468', 'term': 'Prostatectomy'}], 'ancestors': [{'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhodde@CookBiotech.com', 'phone': '765-497-3355', 'title': 'Jason Hodde, Clinical Affairs Manager', 'organization': 'Cook Biotech Incorporated'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Urethrovesical Sling', 'description': 'Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.', 'otherNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control', 'description': 'No sling placed at the time of prostatectomy', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervention to prevent impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Continent Patients Post Prostatectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Urethrovesical Sling', 'description': 'Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.'}, {'id': 'OG001', 'title': 'Control', 'description': 'No sling placed at the time of prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Month', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Urethrovesical Sling', 'description': 'Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.'}, {'id': 'FG001', 'title': 'Control', 'description': 'No sling placed at the time of prostatectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Procedure delayed; enrollment closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Urethrovesical Sling', 'description': 'Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.'}, {'id': 'BG001', 'title': 'Control', 'description': 'No sling placed at the time of prostatectomy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '147 patients were treated with the study procedure.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2009-07-10', 'resultsFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-05', 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Continent Patients Post Prostatectomy', 'timeFrame': '1 Month'}]}, 'conditionsModule': {'keywords': ['prostate cancer', 'prostatectomy', 'incontinence'], 'conditions': ['Urinary Incontinence', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have organ confined prostate cancer.\n* Patients must have PSA\\< 15.\n* Patients must have clinical stage prostate cancer \\< cT3.\n* Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.\n* Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.\n* Patients must be at least 18 years of age.\n\nExclusion Criteria:\n\n* Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.\n* Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.\n* Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.\n* Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.\n* Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.\n* Patients must not have a prior history of radiation to the pelvis.\n* Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.\n* Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.'}, 'identificationModule': {'nctId': 'NCT00937833', 'briefTitle': 'Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling', 'orgStudyIdInfo': {'id': '08-015'}, 'secondaryIdInfos': [{'id': '350017'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urethrovesical Sling', 'description': 'Surgisis Male Sling placed at the time of prostatectomy', 'interventionNames': ['Procedure: Prostatectomy', 'Device: Surgisis Male Sling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Prostatectomy', 'interventionNames': ['Procedure: Prostatectomy']}], 'interventions': [{'name': 'Prostatectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Control', 'Urethrovesical Sling']}, {'name': 'Surgisis Male Sling', 'type': 'DEVICE', 'armGroupLabels': ['Urethrovesical Sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology of San Antonio Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Chandru Sundaram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana Cancer Pavilion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}