Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-01 @ 10:01 PM
Study NCT ID:
NCT01583166
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2012-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.flynn@umassmemorial.org', 'phone': '508-334-9840', 'title': 'Michael Flynn, MD', 'organization': 'UMass Worcester'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Failure to obtain 6-7 hour pain score for 24/80 participants. Impact of large preponderance of slings placed by a subrapublic approach. Study not designed to examine the effect of phenazopyridine in study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'OG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Passed void trial'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Scores at 2-3 Hours Post op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'OG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '2-3 hours', 'description': 'Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please notice that the number of subjects is different because we only analyzed the pain scores from the subjects who were randomized and had the surgery. We also had some missing pain scores'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Scale at 6-7 Hours Post op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'OG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-7 hours', 'description': 'Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study team failed to obtain 6-7 hour pain score for 24 out of the 80 participants. The overall number of participants analyzed reflects this occurence.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale for Pain: Pre-operative.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'OG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At enrollment', 'description': 'Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.', 'unitOfMeasure': 'Reported Pain Level score on VAS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please noticed that there is a discrepancy with the number of subjects. We include the data from all subjects who were randomized and had the intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'FG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Subjects with stress incontinence or stress-predominant mixed urinary incontinence who were scheduled to undergo a retropubic midurethral sling with no concomitant procedures at UMass Memorial Healthcare, Inc.\n\nEnrollment occurred from March 2012 to June 2015 with study presented and consent sought at time of preoperative appointment.', 'preAssignmentDetails': '10 participants did not receive allocated intervention--patient-initiated cancellation of surgery. (Saline + Epinephrine n=6, Bupivavane + Epinephrine n=4). Midway through study, indigo carmine became unavailable and surgical team opted for phenazopyridine. Failed to obtain 6-7 hour pain score in 24 out of 80 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Marcaine + Epinephrine', 'description': 'Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine'}, {'id': 'BG001', 'title': 'Saline + Epinephrine', 'description': 'Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'all subjects were included in the baseline assessments\n\nthe final numbers in the results section differ due to subject withdrawal or drop out'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '45 randomized to each, number analyzed differs due to participant withdrawal'}, {'title': 'Visual Analog Scale for Pain: Preoperative', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '1', 'groupId': 'BG000'}, {'value': '0.0', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '0.0', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were asked to report on pre-operative level of pain using a Visual Analog Scale, The scale is participant reported and ranged form 0 representing no pain to 10 representing unbearable pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2012-04-19', 'resultsFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling', 'timeFrame': '2 weeks', 'description': 'Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Scores at 2-3 Hours Post op', 'timeFrame': '2-3 hours', 'description': 'Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)'}, {'measure': 'Post-operative Pain Scale at 6-7 Hours Post op', 'timeFrame': '6-7 hours', 'description': 'Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)'}, {'measure': 'Visual Analog Scale for Pain: Pre-operative.', 'timeFrame': 'At enrollment', 'description': 'Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '27682748', 'type': 'DERIVED', 'citation': 'Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures\n\nExclusion Criteria:\n\n* Undergoing procedure in addition to the sling\n* Not competent to give consent\n* Using intermittent self catheterization pre-operatively\n* Known allergy to local anesthetic\n* Undergoing spinal anesthesia for the procedure\n* Prisoners\n* Non-English speaker\n* Under 18 years of age\n* Has a condition that would contra-indicate the use of local anesthetic or epinephrine'}, 'identificationModule': {'nctId': 'NCT01583166', 'acronym': 'URINE&ME', 'briefTitle': 'Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine + epinephrine', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline + epinephrine', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': '10ml 0.5% bupivacaine', 'armGroupLabels': ['Bupivacaine + epinephrine']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Sodium Chloride'], 'description': '10ml 0.9% sodium chloride', 'armGroupLabels': ['Saline + epinephrine']}, {'name': 'Epinephrine', 'type': 'DRUG', 'description': '1:200,000 epinephrine', 'armGroupLabels': ['Bupivacaine + epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Michael Flynn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Flynn', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}