Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-10 @ 3:31 PM
Study NCT ID:
NCT02599051
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2015-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transobturator Verus Single Incision Slings
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': 'D053825', 'term': 'Suburethral Slings'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'davilag@ccf.org', 'phone': '9546595559', 'title': 'G W Davila', 'organization': 'Cleveland Clinic Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence', 'otherNumAtRisk': 49, 'otherNumAffected': 2, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence', 'otherNumAtRisk': 49, 'otherNumAffected': 5, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'sling transectio', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mesh exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspareunia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Stress Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'The primary outcome was presence of leakage during cough stress test(CST) on examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire UDI-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Completed Self- Assessment of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire IIQ-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '8.95', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire ICIQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'OG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'FG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence\n\nMonarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence'}, {'id': 'BG001', 'title': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence\n\nMini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '57'}, {'value': '52.9', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '63'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', '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': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2015-11-03', 'resultsFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-28', 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Stress Urinary Incontinence', 'timeFrame': '1 year', 'description': 'The primary outcome was presence of leakage during cough stress test(CST) on examination'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Questionnaire UDI-6', 'timeFrame': '1 year', 'description': "Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life."}, {'measure': 'Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence', 'timeFrame': '1 year', 'description': 'Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination.'}, {'measure': 'Number of Participants Who Completed Self- Assessment of Cure', 'timeFrame': '1 year', 'description': 'Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed.'}, {'measure': 'Quality of Life Questionnaire IIQ-7', 'timeFrame': '1 year', 'description': 'Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected.'}, {'measure': 'Quality of Life Questionnaire ICIQ', 'timeFrame': '1 year', 'description': 'Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urinary Incontinence, Stress']}, 'referencesModule': {'references': [{'pmid': '37888839', 'type': 'DERIVED', 'citation': 'Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.'}]}, 'descriptionModule': {'briefSummary': 'A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling', 'detailedDescription': 'Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.\n\nIn contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.\n\nHowever, to date the success and complications of these two procedures have not been compared or studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.\n\nExclusion Criteria:\n\n* Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.'}, 'identificationModule': {'nctId': 'NCT02599051', 'briefTitle': 'Transobturator Verus Single Incision Slings', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Transobturator Versus Single Incision Slings: 1 Year Results of a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB 9034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monarc', 'description': 'Placement of a transobturator monarc sling for stress urinary incontinence', 'interventionNames': ['Device: Monarc']}, {'type': 'EXPERIMENTAL', 'label': 'Mini-arc', 'description': 'Placement of a single incision mini-arc sling for stress urinary incontinence', 'interventionNames': ['Device: Mini-arc']}], 'interventions': [{'name': 'Mini-arc', 'type': 'DEVICE', 'otherNames': ['single incision sling'], 'description': 'We will place a single incision sling at the time of surgery for stress urinary incontinence', 'armGroupLabels': ['Mini-arc']}, {'name': 'Monarc', 'type': 'DEVICE', 'otherNames': ['transobturator sling'], 'description': 'We will place a transobturator sling at the time of surgery for stress urinary incontinence', 'armGroupLabels': ['Monarc']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'G Willy Davila, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cecilia Calvo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'coordinator', 'investigatorFullName': 'Cecilia Calvo', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}