Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02352103
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ddalela1@hfhs.org', 'phone': '3139162600', 'title': 'Deepansh Dalela, MD', 'organization': 'Vattikuti Urology Institute, Henry Ford Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.", 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 2, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.", 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 4, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small Bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Continence Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '133'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One week after the removal of the suprapubic urinary catheter', 'description': '24-hour pad weights', 'unitOfMeasure': 'grams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Urinary Continence Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 3 months from the intervention', 'description': '0 pad per day', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Peri and Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-year median follow up', 'description': 'Clavien-Dindo complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-year median follow up', 'description': 'SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \\>=22 is normal and \\>=17 is considered mild ED', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-year median follow up', 'description': 'Patients without biochemical evidence of disease recurrence (i.e. postop PSA \\>=0.2 ng/mL)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-operative Urinary Function and Urinary Function-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '6.7'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 3 months from the intervention', 'description': 'International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Who Regained Urinary Continence Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year median follow up', 'description': '0 pad per day', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post-operative Urinary Function and Urinary Function-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year median follow up', 'description': 'MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'FG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm', 'description': "Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System\n\nVattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'BG001', 'title': 'Treatment Arm', 'description': "Retzius sparing radical prostatectomy da Vinci Surgical System\n\nRetzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique\n\nda Vinci Surgical System: The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '67'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '67'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'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': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '26.4', 'upperLimit': '30.9'}, {'value': '27.9', 'groupId': 'BG001', 'lowerLimit': '26.1', 'upperLimit': '30.6'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '26.2', 'upperLimit': '30.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'preoperative prostate specific antigen level', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'BG000', 'lowerLimit': '3.7', 'upperLimit': '7.3'}, {'value': '5.7', 'groupId': 'BG001', 'lowerLimit': '4.7', 'upperLimit': '7.4'}, {'value': '5.6', 'groupId': 'BG002', 'lowerLimit': '4.1', 'upperLimit': '7.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'preoperative IPSS score', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'International Prostatic Symptom Score (IPSS) objectively assesses urinary symptoms. It ranges from 0 to 35, with higher scores indicating worse urinary symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'preoperative SHIM score', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '24'}, {'value': '20', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'description': 'SHIM (Sexual Health Inventory for Men) objectively asses sexual function. It ranges from 0-25, with higher scores indicating better sexual function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'NCCN clinical risk', 'classes': [{'categories': [{'title': 'Low Risk', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Intermediate Risk', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NCCN (National Comprehensive Cancer Network) risk categorizes prostate cancer based on their likelihood of disease progression, recurrence and outcomes, into low, intermediate, high and very high risk groups. It uses clinical information (i.e information available PRIOR to surgery) for this (i.e PSA, biopsy gleason score and clinical T stage)', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2015-01-22', 'resultsFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-26', 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients Who Regained Urinary Continence Postoperatively', 'timeFrame': '1 year median follow up', 'description': '0 pad per day'}, {'measure': 'Post-operative Urinary Function and Urinary Function-related Quality of Life', 'timeFrame': '1 year median follow up', 'description': 'MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function'}], 'primaryOutcomes': [{'measure': 'Urinary Continence Recovery', 'timeFrame': 'One week after the removal of the suprapubic urinary catheter', 'description': '24-hour pad weights'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Urinary Continence Recovery', 'timeFrame': 'within 3 months from the intervention', 'description': '0 pad per day'}, {'measure': 'Number of Participants With Peri and Postoperative Complications', 'timeFrame': '1-year median follow up', 'description': 'Clavien-Dindo complications'}, {'measure': 'Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)', 'timeFrame': '1-year median follow up', 'description': 'SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \\>=22 is normal and \\>=17 is considered mild ED'}, {'measure': 'Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)', 'timeFrame': '1-year median follow up', 'description': 'Patients without biochemical evidence of disease recurrence (i.e. postop PSA \\>=0.2 ng/mL)'}, {'measure': 'Post-operative Urinary Function and Urinary Function-related Quality of Life', 'timeFrame': 'Within 3 months from the intervention', 'description': 'International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'Urinary continence', 'robotic assisted radical prostatectomy', 'Vattikuti Urology Institute (VIP) radical prostatectomy', 'Retzius sparing radical prostatectomy'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '28483330', 'type': 'RESULT', 'citation': 'Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6.'}, {'pmid': '29225060', 'type': 'RESULT', 'citation': 'Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/28483330/', 'label': 'A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29225060/', 'label': 'Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches'}]}, 'descriptionModule': {'briefSummary': 'To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.', 'detailedDescription': 'Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality\n* Be able to read and speak English and be able to provide written informed consent\n\nExclusion Criteria:\n\n* patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.\n* evidence of clinical nodal involvement (cN1) or metastatic disease (M1)\n* patients participating in a competing study\n* patients with pre-operative urinary incontinence.'}, 'identificationModule': {'nctId': 'NCT02352103', 'briefTitle': 'Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '9220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System', 'interventionNames': ['Procedure: Vattikuti Urology Institute radical prostatectomy', 'Device: da Vinci Surgical System']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Retzius sparing radical prostatectomy da Vinci Surgical System', 'interventionNames': ['Procedure: Retzius sparing radical prostatectomy', 'Device: da Vinci Surgical System']}], 'interventions': [{'name': 'Retzius sparing radical prostatectomy', 'type': 'PROCEDURE', 'description': 'Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique', 'armGroupLabels': ['Treatment arm']}, {'name': 'Vattikuti Urology Institute radical prostatectomy', 'type': 'PROCEDURE', 'description': 'Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique', 'armGroupLabels': ['Control arm']}, {'name': 'da Vinci Surgical System', 'type': 'DEVICE', 'description': "The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.", 'armGroupLabels': ['Control arm', 'Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford West Bloomfield Hospital', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}], 'overallOfficials': [{'name': 'Mani Menon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Vattikuti Urology Institute', 'investigatorFullName': 'Mani Menon', 'investigatorAffiliation': 'Henry Ford Health System'}}}}