Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT05380661
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2022-05-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D020211', 'term': 'Autonomic Dysreflexia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057928', 'term': 'Intermittent Urethral Catheterization'}], 'ancestors': [{'id': 'D014546', 'term': 'Urinary Catheterization'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants blinded to order of catheterization procedures conducted by the urology nurse.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure (BP) during self-catheterization', 'timeFrame': 'During self-catheterization', 'description': 'Systolic and diastolic BP (mmHg) will be measured continuously (beat-by-beat) via finger photoplethysmography, corrected to brachial pressure. BP will be measured 5 minutes prior to and then throughout the self-catheterization procedure.'}, {'measure': 'Heart rate (HR) during self-catheterization', 'timeFrame': 'During self-catheterization', 'description': 'HR (BPM) will be recorded continuously via one-lead electrocardiogram. HR will be measured 5 minutes prior to and then throughout the self-catheterization procedure.'}, {'measure': 'BP during catheterization performed by urology nurse, participant blinded to time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant blinded to time of procedure', 'description': 'Systolic and diastolic BP (mmHg) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.'}, {'measure': 'HR during catheterization performed by urology nurse, participant blinded to time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant blinded to time of procedure', 'description': 'HR (BPM) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.'}, {'measure': 'BP during catheterization performed by urology nurse, participant aware of time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant aware of time of procedure', 'description': 'Systolic and diastolic BP (mmHg) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is aware of time of procedure.'}, {'measure': 'HR during catheterization performed by urology nurse, participant aware of time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant aware of time of procedure', 'description': 'HR (BPM) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is aware of time of procedure.'}, {'measure': 'Change in state anxiety in the context of self-catheterization (STAIS-5)', 'timeFrame': '5 minutes before and 5 minutes after self-catheterization', 'description': "The State-Trait Anxiety Inventory - State, 5 item version (STAIS-5) will be used to measure participants' state anxiety prior to and after self-catheterization. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety."}, {'measure': 'Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)', 'timeFrame': '5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure', 'description': "The STAIS-5 will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is blinded to time of procedure. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety."}, {'measure': 'Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)', 'timeFrame': '5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure', 'description': "The STAIS-5 will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is aware of time of procedure. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety."}], 'secondaryOutcomes': [{'measure': 'Baseline trait anxiety', 'timeFrame': 'During screening', 'description': "The 7-item General Anxiety Disorder (GAD) scale will be used to measure participants' anxiety. The GAD-7 sum score will be calculated, ranging from 0 to 21, with higher score indicating more severe anxiety symptoms."}, {'measure': 'Change in state anxiety in the context of self-catheterization (GA-VAS)', 'timeFrame': '5 minutes before and 5 minutes after self-catheterization', 'description': "The Global Anxiety-Visual Analogue Scale (GA-VAS) will be used to measure participants' state anxiety prior to and after self-catheterization. Rating can range between 0 to 10, with higher rating on the GA-VAS indicates greater state anxiety."}, {'measure': 'Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)', 'timeFrame': '5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure', 'description': "The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is blinded to time of procedure. Rating can range between 0 to 10, higher rating on the GA-VAS indicates greater state anxiety."}, {'measure': 'Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)', 'timeFrame': '5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure', 'description': "The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is aware of time of procedure. Higher rating on the GA-VAS indicates greater state anxiety."}, {'measure': 'Change in heart rate variability (HRV) during self-catheterization', 'timeFrame': 'During self-catheterization', 'description': 'HRV will be calculated from continuous ECG recording'}, {'measure': 'Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant blinded to time of procedure', 'description': 'HRV will be calculated from continuous ECG recording'}, {'measure': 'Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure', 'timeFrame': 'During catheterization performed by urology nurse, participant aware of time of procedure', 'description': 'HRV will be calculated from continuous ECG recording'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intermittent Catheterization'], 'conditions': ['Spinal Cord Injuries', 'Urinary Bladder, Neurogenic', 'Anxiety State', 'Catheter Complications', 'Autonomic Dysreflexia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).', 'detailedDescription': 'Given that intermittent catheterization is the recommended method of bladder management in individuals with SCI, it is crucial that the potentially negative cardiovascular and psychological responses to this procedure are examined. Individuals will undergo self-catheterization, then two standard of care catheterization procedures performed by an experienced urology nurse, while either blinded to or aware of time of catheterization. Continuous cardiovascular monitoring will be in place throughout all three procedures. Assessment of anxiety will be administered pre- and post- each procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18-70 years of age\n* Any chronic traumatic SCI with either motor sensory complete injury (AIS A/B, N=10) or motor sensory incomplete injury (AIS B/D, N=10).\n* At least 1 year post injury, and at least 6 months from any spinal surgery\n* Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage\n* Must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator)\n* Willing and able to comply with clinic visit and study-related procedures\n\nExclusion Criteria:\n\n* Signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra\n* Currently taking beta blockers or other medications that may affect heart rate\n* History of ureteral injury\n* History of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy\n* For women of childbearing potential, currently pregnant\n* A member of the investigational team or his/her immediate family Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study"}, 'identificationModule': {'nctId': 'NCT05380661', 'briefTitle': 'Heart Rate Variability and Anxiety During Urinary Bladder Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort', 'orgStudyIdInfo': {'id': 'H22-00971'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individuals with motor-complete SCI', 'description': 'Individuals with motor sensory complete injury (AIS A/B)', 'interventionNames': ['Procedure: Self-catheterization', 'Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure', 'Procedure: Catheterization performed by urology nurse, participant aware of time of procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Individuals with motor-incomplete SCI', 'description': 'Individuals with motor sensory incomplete injury (AIS C/D)', 'interventionNames': ['Procedure: Self-catheterization', 'Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure', 'Procedure: Catheterization performed by urology nurse, participant aware of time of procedure']}], 'interventions': [{'name': 'Self-catheterization', 'type': 'PROCEDURE', 'description': 'Participants will perform self-catheterization, following the same routine for intermittent catheterization at home', 'armGroupLabels': ['Individuals with motor-complete SCI', 'Individuals with motor-incomplete SCI']}, {'name': 'Catheterization performed by urology nurse, participant blinded to time of procedure', 'type': 'PROCEDURE', 'description': 'Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting blood pressure and heart rate will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be draped and they will be not aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.', 'armGroupLabels': ['Individuals with motor-complete SCI', 'Individuals with motor-incomplete SCI']}, {'name': 'Catheterization performed by urology nurse, participant aware of time of procedure', 'type': 'PROCEDURE', 'description': 'Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting BP and HR will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be visible to participant and they will be fully aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.', 'armGroupLabels': ['Individuals with motor-complete SCI', 'Individuals with motor-incomplete SCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrea Maharaj, BSc', 'role': 'CONTACT', 'email': 'amaharaj@icord.org', 'phone': '6046758856'}, {'name': 'Andrei Krassioukov, MD,PhD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Blusson Spinal Cord Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Andrea Maharaj, BSc', 'role': 'CONTACT', 'email': 'amaharaj@icord.org', 'phone': '(604) 675-8856'}], 'overallOfficials': [{'name': 'Andrei Krassioukov, MD,PhD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, {'name': 'Vancouver Coastal Health', 'class': 'OTHER_GOV'}, {'name': 'International Collaboration on Repair Discoveries', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrei Krassioukov', 'investigatorAffiliation': 'University of British Columbia'}}}}