Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-30 @ 7:35 PM
Study NCT ID:
NCT00883103
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2009-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test
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': 'C008371', 'term': 'phenylmercury borate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oz.harmanli@baystatehealth.org', 'phone': '4137945608', 'title': 'Oz Harmanli, MD', 'organization': 'Baystate Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Gel', 'description': '2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'otherNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'Lidocaine gel was applied to the Q-tip and the catheter before insertion.'}, {'id': 'OG001', 'title': 'Aqueous Gel', 'description': 'Aqueous gel was applied to the Q-tip and the catheter before insertion.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': 'number', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately after the examination', 'description': "A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Gel', 'description': '2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Gel', 'description': '2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', '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/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Previous Live Births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous Vaginal Births', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Previous Vaginal Births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal Atrophy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Neurological Impairment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'History of stroke, or degenerative vertebral disease without loss of sensation.', 'unitOfMeasure': 'Participants'}, {'title': 'Current Estrogen Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Examination Anxiety', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Self reported as yes/no by participant, recorded before exam.', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for the Visit', 'classes': [{'title': 'Urinary Incontinence', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Pelvic Organ Prolapse', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Both', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2009-04-15', 'resultsFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2009-04-16', 'lastUpdatePostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-10', 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain", 'timeFrame': 'Immediately after the examination', 'description': "A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['female urethral catheterization', 'Lidocaine', 'lubricant', 'Q-tip test', 'Q tip test', 'K-Y jelly', 'pain perception', 'straight catheterization'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '19701033', 'type': 'RESULT', 'citation': 'Harmanli OH, Okafor O, Ayaz R, Knee A. Lidocaine jelly and plain aqueous gel for urethral straight catheterization and the Q-tip test: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):547-550. doi: 10.1097/AOG.0b013e3181b43808.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.', 'detailedDescription': "This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will be then randomized either to 2% Lidocaine Hydrochloride jelly (Akorn, Buffalo Grove, IL) or Surgilube (Fougera, Melville, NY) using computer generated blocks of 10. The latter is a commonly used, commercially available aqueous lubricant gel. Both the urogynecologist who perform the examinations and the patient will be blinded to the randomization. The appearances of the study gels are indistinguishable. Based on our power analysis targeting a power of 0.80, an α value of 0.05, and 20% difference in pain perception between the groups, we are aiming to recruit a sample of minimum132 subjects.\n\nFirst, demographic information including the age, parity, previous vaginal births, body mass index (BMI), race, diabetes, vaginal atrophy, neurological impairment, current estrogen use, indication for visit and exam anxiety will be collected as a part of patient history. Immediately after voiding, each patient will be placed in a lithotomy position. An independent nurse who is not involved in patient's care will prepare the study gels according to the randomization. After cleansing external urethral meatus with povidone iodine solution, a lubricated a sterile 14-French polyvinyl chloride Mentor Self-Cath catheter (Coloplast, Minneapolis, MN) will be placed transurethrally into the bladder to measure the postvoid residual volume. Following removal of the catheter, a cotton swab, lubricated with the same allocated gel, will be advanced to the urethrovesical junction until resistance was felt. The angle of the Q-tip with the horizontal plane will be measured at rest and with Valsalva maneuver. All the examinations will be performed by the same urogynecologist in the same order. Immediately following the Q-tip test, patient's perception of pain level will be measured using a validated pain scoring system, the Wong-Baker FACES visual scale where 0 represented no pain and 5 represented worst imaginable pain. The rest of the physical examination will be completed after this pain assessment.\n\nWe will evaluate patient characteristics and pain score variables by exposure to either Lidocaine or Surgilube using SPSS Version 11.01 software (Chicago, Illinois). For continuous variables, we will calculate the mean and standard deviation and then evaluate significant differences using the Mann Whitney U test. For categorical variables, we will calculate the number and percent and then evaluate significant differences using Pearson's chi-square test. Significance for all results was set at an alpha of \\<0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse\n\nExclusion Criteria:\n\n* Being a minor\n* Pregnancy\n* Allergy to Lidocaine or aqueous lubricant gel\n* Any current use of analgesia\n* Structural abnormalities of the urethra\n* Active genital Herpes or other vulvovaginal infections or inability to cooperate with pain assessment due to mental disorders."}, 'identificationModule': {'nctId': 'NCT00883103', 'briefTitle': 'Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test', 'organization': {'class': 'OTHER', 'fullName': 'Baystate Medical Center'}, 'officialTitle': 'Double Blinded Randomized Trial Between Lidocaine Jelly And Plain Aqueous Gel For Urethral Straight Catheterization And The Q-Tip Test', 'orgStudyIdInfo': {'id': '07-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': '2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'interventionNames': ['Drug: 2% Lidocaine jelly']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aqueous gel', 'description': 'Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'interventionNames': ['Drug: Plain aqueous gel']}], 'interventions': [{'name': '2% Lidocaine jelly', 'type': 'DRUG', 'description': '2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Plain aqueous gel', 'type': 'DRUG', 'otherNames': ['Surgilube'], 'description': 'Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.', 'armGroupLabels': ['Aqueous gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Oz Harmanli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baystate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baystate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Oz Harmanli, MD', 'oldOrganization': 'Baystate Medical Center'}}}}