Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01382602
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2011-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Hong Kong', 'Netherlands']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ron.Jankowski@CookMyosite.com', 'phone': '412-963-7380', 'title': 'Ron Jankowski, PhD', 'organization': 'Cook MyoSite Incorporated'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Planned study enrollment was 246 patients; due to limitations in study design related to the primary efficacy endpoint, enrollment was halted early at 150 subjects.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from consent through study exit. Reporting groups are based on adverse events that occurred between initial blinded injection treatment and unblinding of subjects after 12-month follow-up.', 'description': 'Adverse events that occurred between initial blinded injection and unblinding of subjects after 12-month follow-up were compared between AMDC-USR and Placebo groups.', 'eventGroups': [{'id': 'EG000', 'title': 'AMDC-USR', 'description': 'Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of AMDC-USR, at the 12 month follow-up.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 32, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. Analysis population is based on subjects that underwent at least 1 treatment of placebo, at the 12 month follow-up.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 13, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '90'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is based on subjects that received at least 1 treatment of AMDC-USR or placebo at the 12 months follow-up..'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMDC-USR', 'description': 'Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. Analysis population is based on subjects that received at least 1 treatment of AMDC-USR at the 12 months follow-up.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up, subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received open-label AMDC-USR treatment were followed for 2 years after initial placebo treatment. Analysis population is based on subjects that received at least 1 treatment of placebo at the 12 months follow-up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled at 10 sites globally; 8 sites in Canada, 1 site in Germany, and 1 site in United Kingdom.', 'preAssignmentDetails': '227 subjects consented to study participation and were screened for eligibility, of whom 150 subjects were enrolled (underwent biopsy procedure) and 143 subjects underwent at least 1 study treatment AMDC-USR (93 subjects) or placebo (50 subjects). Analysis population is based on 143 subjects that underwent at least 1 study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AMDC-USR', 'description': 'Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection.'}, {'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': '82', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '143', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'Canada', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '150 subjects were enrolled and 143 subjects received at least 1 treatment of either AMDC-USR or placebo. Analysis population is based on 143 subjects that underwent at least 1 study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2017-02-02', 'completionDateStruct': {'date': '2017-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2011-06-24', 'dispFirstSubmitQcDate': '2017-02-02', 'resultsFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2011-06-24', 'dispFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-18', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months', 'timeFrame': '12 months', 'description': 'A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence, Stress', 'Tissue Therapy (Cell Therapy)', 'Transplantation, Autologous'], 'conditions': ['Urinary Incontinence, Stress']}, 'referencesModule': {'references': [{'pmid': '30178605', 'type': 'DERIVED', 'citation': 'Fontaine F, Tu LM, Carroll MS, Morin M. Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment. Neurourol Urodyn. 2018 Nov;37(8):2875-2880. doi: 10.1002/nau.23805. Epub 2018 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).', 'detailedDescription': 'Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.\n\nExclusion Criteria:\n\n* Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.\n* Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.\n* Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.\n* Patient has not previously attempted conservative treatment for at least 1 month prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)\n* Patient has more than 2 episode of awakening to void during normal sleeping hours.\n* Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course of the study.\n* Patient is pregnant, lactating, or plans to become pregnant during the course of the study.\n* Patient refuses to provide written informed consent.\n* Patient is not at least 18 years of age.\n* Patient is not available for the follow-up evaluations as required by the protocol.'}, 'identificationModule': {'nctId': 'NCT01382602', 'briefTitle': 'Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook MyoSite'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': '10-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMDC-USR', 'description': 'Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment.', 'interventionNames': ['Biological: AMDC-USR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'AMDC-USR', 'type': 'BIOLOGICAL', 'description': 'AMDC-USR Treatment', 'armGroupLabels': ['AMDC-USR']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2V 1P9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Southern Alberta Institute of Urology', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V8R 6R3', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Gynecology and Continence Clinic', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'V8T 5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Can-Med Clinical Research Inc.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Applied Urological Research Queens University', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '45468', 'city': 'Mülheim', 'country': 'Germany', 'facility': 'Praxisklinik Urologie Rhein-Ruhr', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': 'BN11 2DH', 'city': 'Worthing', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'overallOfficials': [{'name': 'Lesley K. Carr, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook MyoSite', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}