Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 5:27 AM
Study NCT ID:
NCT05207969
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006417', 'term': 'Hematuria'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D001744', 'term': 'Urinary Bladder Calculi'}, {'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1)To determine the efficacy of the act of urination in reducing patient urethral pain during flexible cystoscopy procedure.', 'timeFrame': 'During cystoscopy procedure', 'description': 'To determine the efficacy of the act of urination , we will use visual analogue score (VAS) , subjective assessment for assessing the patient pain score.'}], 'secondaryOutcomes': [{'measure': '2)To determine the association between the act of urination with relaxation of external urethral sphincter during flexible cystoscopy procedure.', 'timeFrame': 'During cystoscopy procedure', 'description': 'We will use electromyography (EMG) as objective assessent to determine association between act of urination and relaxation of external urethral sphinter.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematuria', 'Bladder Ca', 'Bladder Stone', 'Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'This research is about modification during routine cystoscopy (scope in the bladder) procedure \\[ experimental research \\]. The goal of the study is to evaluate patient experience with cystoscopy by using procedural modification to reduce pain perception. The investigator aim for quality improvement of the current methods of cystoscopy to achieve a better patient experience.', 'detailedDescription': 'Study Area\n\n-Department of Urology, Hospital Universiti Sains Malaysia.\n\nStudy population. -Patient who is required for flexible cystoscopy procedure attending Urology Unit in Hospital USM\n\nParticipants\n\nInclusion Criteria :\n\n• Adult (\\>18 years old)\n\nExclusion criteria:\n\n* Analgesic use within 24hours\n* History of stricture ,urinary tract infection, existing urethral pain\n* Secondary procedure(example stent, stone removal, fulguration)\n\nWithdrawal Criteria\n\n* Change of mind\n* Found to be outside the parameters of inclusion criteria, and inside the parameters of exclusion criteria\n* Breach of Protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more 18 years old\n\nExclusion Criteria:\n\n* Analgesic use within 24hours\n* History of stricture ,urinary tract infection, existing urethral pain\n* Secondary procedure(exp stent, stone removal, fulguration)'}, 'identificationModule': {'nctId': 'NCT05207969', 'briefTitle': 'Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Efficacy of the Act of Urination to Relief the Pain During Flexible Cystoscopy Procedure.', 'orgStudyIdInfo': {'id': 'HUSMKK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure patient will not giving instruction to urinate during the procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder', 'interventionNames': ['Procedure: Instruction to urinate']}], 'interventions': [{'name': 'Instruction to urinate', 'type': 'PROCEDURE', 'otherNames': ['voiding instruction'], 'description': 'Cystoscopy procedure will be done based on cystoscopy protocol. During scope procedure, patient will be ask to urinate and this will lead to contraction of urinary bladder and relaxation of external urethral sphincter. Scope will then pass through external urethral sphinter and go to the urinary bladder', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15100', 'city': 'Kota Bharu', 'state': 'Kelantan', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'MUNAWWAR BIN MOHD ADNAN, MD', 'role': 'CONTACT', 'email': 'munir_120@hotmail.com', 'phone': '0174388516'}], 'facility': 'Hospital University Sains Malaysia', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}], 'centralContacts': [{'name': 'MUNAWWAR ADNAN DR, MD', 'role': 'CONTACT', 'email': 'munir_120@hotmail.com', 'phone': '+60174388516'}], 'overallOfficials': [{'name': 'MUNAWWAR BIN ADNAN DR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUSM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Munawwar Bin Mohd Adnan', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}