Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT00945594
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003558', 'term': 'Cystoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lieschen-quiroz@ouhsc.edu', 'phone': '405-271-8787', 'title': 'Lieschen Quiroz, MD', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'OG001', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}], 'classes': [{'title': 'No new symptoms', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Frequency', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Urgency', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Blood in urine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Burning with urination', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Urinary infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week after procedure', 'description': 'Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a "yes" or "no"', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 42 participants and 43 participants were analyzed from each group, respectively. Some participants may have reported multiple symptoms, which is why the numbers below may exceed to total number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Duration of Post-procedure Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'OG001', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after procedure', 'description': 'Duration of post-procedure complications, surveyed 1 week post procedure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'OG001', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.72'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately after procedure', 'description': 'The Visual analog pain scale measures patient-reported pain levels from 0-10, with 0 being no pain reported and 10 being the highest level of pain reported. In this study, researchers compared pain levels between females who had rigid and flexible cystoscopies.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'FG001', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flexible Cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'BG001', 'title': 'Rigid Cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)\n\nCystoscopy: A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2009-07-22', 'resultsFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-05', 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.', 'timeFrame': '1 week after procedure', 'description': 'Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a "yes" or "no"'}, {'measure': 'Duration of Post-procedure Complications', 'timeFrame': '1 week after procedure', 'description': 'Duration of post-procedure complications, surveyed 1 week post procedure'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Pain Scale', 'timeFrame': 'Immediately after procedure', 'description': 'The Visual analog pain scale measures patient-reported pain levels from 0-10, with 0 being no pain reported and 10 being the highest level of pain reported. In this study, researchers compared pain levels between females who had rigid and flexible cystoscopies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['flexible cystoscopy', 'rigid cystoscopy', 'bladder', 'outcome assessment', 'pain measurement'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.', 'detailedDescription': 'This will be a prospective randomized trial study in order to determine to compare rigid and flexible cystoscopy in female patients. Patients will be recruited from OU Physicians Pelvic and Bladder Health clinic. Patients receive an information leaflet describing the procedure prior to their appointment. All procedures are performed by the attending physician. Procedures performed by residents and/or fellows are excluded from this study. The vulva is cleaned with antiseptic solution and 10 ml of Xylocaine 2% is be instilled into the urethra before the endoscope was introduced. A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA) is used to enable optimal visualization of the lateral bladder wall in those with previous continence surgeries. The investigator may choose to use a 30° scope when appropriate. Cystoscopy is commenced by recording a postvoid residual ensuring appropriate bladder emptying prior to filling. Filling is performed with continuous saline infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). A standard systematic approach was adopted to ensure global assessment of the vesical surface. This included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral orifices. The urethroscopy portion of the procedure is performed last. When performing rigid cystoscopy, a 0° degree lens is used for this portion of the procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the following indications for outpatient cystourethroscopy:\n\n 1. Microscopic hematuria or\n 2. Voiding dysfunction, or recurrence of urinary incontinence, or\n 3. History of recurrent bacterial cystitis\n* Age \\>18\n* Patient willingness to enroll\n* Patient able to read and understand an English language self- administered questionnaire.\n\nExclusion Criteria:\n\n* Severe detrussor overactivity\n* Interstitial cystitis or chronic urethral or bladder pain\n* Acute urinary tract infection\n* Urinary retention defined as a post void residual \\>120cc\n* Pregnancy or planning pregnancy within the next 3 months\n* Prior urethral surgery\n* Dementia or inability to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT00945594', 'briefTitle': 'Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Randomized Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females', 'orgStudyIdInfo': {'id': 'Cystoscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible cystoscopy', 'description': '16F flexible cysto urethroscope (Storz, Culver city, CA)', 'interventionNames': ['Device: Cystoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Rigid cystoscopy', 'description': '17F, 70° scope (Storz, Culver city, CA)', 'interventionNames': ['Device: Cystoscopy']}], 'interventions': [{'name': 'Cystoscopy', 'type': 'DEVICE', 'description': 'A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)', 'armGroupLabels': ['Flexible cystoscopy', 'Rigid cystoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Lieschen H Quiroz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}