Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-07 @ 11:06 AM
Study NCT ID:
NCT04646434
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'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': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}, {'id': 'D014563', 'term': 'Urodynamics'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG measures obtained during urination.', 'timeFrame': 'Up to 6 months after surgery', 'description': 'Recordings of brain and muscle activity will be collected during urination'}, {'measure': 'Pelvic floor muscle (PFM) EEG measures', 'timeFrame': 'Up to 6 months', 'description': 'Simultaneous recordings of brain activity using electrodes attached to the scalp and muscle activities of muscles of the anal sphincter with electrodes bonded to the skin.'}, {'measure': 'Identification of Areas of synchrony in EEG Patterns and associated Urodynamics (UDS) findings', 'timeFrame': 'UP to 6 months', 'description': 'UDS data of Incontinence/continence will be monitored along with EEG recordings of brain activity during urination.'}], 'secondaryOutcomes': [{'measure': 'EEG and EMG biofeedback', 'timeFrame': 'Up to 6 months', 'description': 'Patients will perform Kegel exercises while brain and muscle activity are monitored using a 128-channel EEG headset and up to 24 channel EMG system'}, {'measure': 'Improvement of continence', 'timeFrame': 'Throughout life of study up to 6 months after surgery', 'description': 'International Prostate Symptom score - an 8 question screening tool -with a score from 0= never experienced to 5= almost always experienced.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. This trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\n* Identify pelvic floor muscle (PFM) activity on electromyogram (EMG) and electroencephalography (EEG).\n* Identify any synchrony in EMG and EEG for PFM activity.\n* Identify any relationship between EEG activity and UDS findings.\n\nSECONDARY OBJECTIVES:\n\nI. Identify changes in EEG and EMG activity with Kegel exercise. II. Examine relationship between EEG activity and continence.\n\nEXPLORATORY OBJECTIVE:\n\nI. Examine feasibility of replacing EMG with EEG monitoring for muscle activity.\n\nOUTLINE:\n\nPatients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by EEG and EMG and UDS, respectively, before surgery, 6 weeks after surgery, 3,months after surgery and 6 months after surgery.. Patients complete questionnaires over 5-10 minutes about urinary function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults who had or are undergoing robot-assisted radical prostatectomy (RARP)\n* Must be continent preoperatively\n* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation"}, 'identificationModule': {'nctId': 'NCT04646434', 'briefTitle': 'Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Investigating the Correlation Between the Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'I 822320'}, 'secondaryIdInfos': [{'id': 'NCI-2020-08299', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 822320', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (brain and muscle monitoring, questionnaire)', 'description': 'Patients perform standard of care Kegel exercises while undergoing brain and muscle activity monitoring by UDS, EEG and EMG, respectively, before surgery, 6 weeks after surgery, and at 3, and 6 months after surgery. Patients complete questionnaires over 5-10 minutes about urinary function', 'interventionNames': ['Procedure: Electroencephalography', 'Procedure: Electromyography', 'Other: Questionnaire Administration', 'Procedure: Urodynamics (UDS)']}], 'interventions': [{'name': 'Electroencephalography', 'type': 'PROCEDURE', 'otherNames': ['EEG', 'electroencephalogram'], 'description': 'Undergo EEG', 'armGroupLabels': ['Supportive Care (brain and muscle monitoring, questionnaire)']}, {'name': 'Electromyography', 'type': 'PROCEDURE', 'otherNames': ['EMG'], 'description': 'Undergo EMG', 'armGroupLabels': ['Supportive Care (brain and muscle monitoring, questionnaire)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaire', 'armGroupLabels': ['Supportive Care (brain and muscle monitoring, questionnaire)']}, {'name': 'Urodynamics (UDS)', 'type': 'PROCEDURE', 'otherNames': ['UDS'], 'description': 'Undergo UDS', 'armGroupLabels': ['Supportive Care (brain and muscle monitoring, questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Khurshid A. Guru', 'role': 'CONTACT', 'email': 'Khurshid.Guru@roswellpark.org', 'phone': '716-845-4107'}, {'name': 'Khurshid A. Guru', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Khurshid A Guru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}