Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 12:25 PM
Study NCT ID:
NCT02291432
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'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': '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': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from enrollment through study exit - 24 months total.', 'description': 'All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Micturition urgency', 'notes': 'Study Product-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Pollakiuria', 'notes': 'Study Product-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Post procedural contusion', 'notes': 'Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Post procedural swelling', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Procedural hypotension', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Procedural nausea', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Procedural pain', 'notes': 'Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Arthralgia', 'notes': '1 Event Biopsy Procedure-Related Adverse Event, 1 Event Not Related to Study Product or Procedures, AEs with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Hypoaesthesia', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Erythema', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Hyperhidrosis', 'notes': 'Biopsy Procedure-Related Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Abdominal Pain', 'notes': 'AEs Not Related to Study Product or Procedures with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Sinusitis', 'notes': 'AEs Not Related to Study Product or Procedures with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Fall', 'notes': 'AEs Not Related to Study Product or Procedures with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Laceration', 'notes': 'AEs Not Related to Study Product or Procedures with ≥5% Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Study product-related serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Product-related adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Injection procedure-related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy procedure-related adverse events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled (biopsied)'}, {'type': 'PRIMARY', 'title': 'Volume of Post-void Residual (PVR) Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Post void residual volume 1 month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '52'}]}]}, {'title': 'Post void residual volume 3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '37'}]}]}, {'title': 'Post void residual volume 6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '142'}]}]}, {'title': 'Post void residual volume 12 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.', 'unitOfMeasure': 'millileters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': '24 hour pad weight at 1 month', 'categories': [{'measurements': [{'value': '101.2', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '674.3'}]}]}, {'title': '24 hour pad weight at 3 months', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '357'}]}]}, {'title': '24 hour pad weight at 6 months', 'categories': [{'measurements': [{'value': '104.9', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '359.5'}]}]}, {'title': '24 hour pad weight at 12 months', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '319.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.', 'unitOfMeasure': 'grams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': '≥50% reduction in 24 hour pad weight at 1 month', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '≥50% reduction in 24 hour pad weight at 3 months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '≥50% reduction in 24 hour pad weight at 6 months', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '≥50% reduction in 24 hour pad weight at 12 months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Change in I-QOL total score at 1 month', 'categories': [{'measurements': [{'value': '-6.8', 'groupId': 'OG000', 'lowerLimit': '-14.8', 'upperLimit': '6.8'}]}]}, {'title': 'Change in I-QOL total score at 3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-27.3', 'upperLimit': '9.1'}]}]}, {'title': 'Change in I-QOL total score at 6 months', 'categories': [{'measurements': [{'value': '-9.1', 'groupId': 'OG000', 'lowerLimit': '-37.5', 'upperLimit': '12.5'}]}]}, {'title': 'Change in I-QOL total score at 12 months', 'categories': [{'measurements': [{'value': '-9.1', 'groupId': 'OG000', 'lowerLimit': '-36.4', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL.', 'unitOfMeasure': 'points', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Change in ICIQ score at 1 month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '7'}]}]}, {'title': 'Change in ICIQ score at 3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '7'}]}]}, {'title': 'Change in ICIQ score at 6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '7'}]}]}, {'title': 'Change in ICIQ score at 12 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Change in I-PSS score at 1 month', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '8'}]}]}, {'title': 'Change in I-PSS score at 3 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '10'}]}]}, {'title': 'Change in I-PSS score at 6 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '15'}]}]}, {'title': 'Change in I-PSS score at 12 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'PGI-S score at 1 month', 'categories': [{'title': 'Normal', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'PGI-S score at 3 months', 'categories': [{'title': 'Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PGI-S score at 6 months', 'categories': [{'title': 'Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PGI-S score at 12 months', 'categories': [{'title': 'Normal', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'PGI-I score at 1 month', 'categories': [{'title': 'Very much better', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much better', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'A little better', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'A little worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'PGI-I score at 3 months', 'categories': [{'title': 'Very much better', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much better', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'A little better', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'A little worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PGI-I score at 6 months', 'categories': [{'title': 'Very much better', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much better', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'A little better', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'A little worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PGI-I score at 12 months', 'categories': [{'title': 'Very much better', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much better', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'A little better', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'A little worse', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 1-Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, and 7-Very much worse. Percentages of participants in each category were determined at each visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'classes': [{'title': 'Change in IEEF-5 score at 1 month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '8'}]}]}, {'title': 'Change in IEEF-5 score at 3 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '8'}]}]}, {'title': 'Change in IEEF-5 score at 6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '4'}]}]}, {'title': 'Change in IEEF-5 score at 12 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects injected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 Autologous Muscle-Derived Cells (AMDCs)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Muscle Biopsy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'AMDC Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': '1-Month Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': '3-Month Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': '6-Month Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': '12-Month Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AMDC-USR', 'description': 'Single intraurethral injection of 150 x 10\\^6 autologous muscle-derived cells (AMDCs).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Participant Age', 'categories': [{'measurements': [{'value': '67.2', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Urinary Incontinence Type', 'classes': [{'title': 'Pure Stress Urinary Incontinence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Mixed Urinary Incontinence, Stress Predominant', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Mixed Urinary Incontinence, Urge Predominant', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '24-hour Pad Test Weight', 'classes': [{'categories': [{'measurements': [{'value': '109.1', 'groupId': 'BG000', 'lowerLimit': '4.1', 'upperLimit': '431'}]}]}], 'paramType': 'MEDIAN', 'description': 'A test in which the participant wears specific absorbent pads dispensed by the clinic. The pads are weighed to record the pre-test weight prior to dispensing to the participant. The participant must wear the absorbent pads for 24 hours. The participant returns the used absorbent pads to the clinic, and the clinic records the post-test weight to determine urinary leakage for the 24 hour period. The difference in weights represent the amount of urine leaked.', 'unitOfMeasure': 'grams', 'dispersionType': 'FULL_RANGE'}, {'title': 'Incontinence Quality of Life (I-QOL)', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '87.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to 100, with higher scores indicating a better QOL.', 'unitOfMeasure': 'scores on scales', 'dispersionType': 'FULL_RANGE'}, {'title': 'International Consultation on Incontinence Questionnaire (ICIQ)', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'description': 'The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.', 'unitOfMeasure': 'scores on scales', 'dispersionType': 'FULL_RANGE'}, {'title': 'International Prostate Symptom Score (IPSS)', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'description': 'The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.', 'unitOfMeasure': 'scores on scales', 'dispersionType': 'FULL_RANGE'}, {'title': 'International Index of Erectile Function (IIEF)', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'description': 'The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction (ED). Scored from 5 to 25, with lower scores indicating less ED symptoms.', 'unitOfMeasure': 'scores on scales', 'dispersionType': 'FULL_RANGE'}, {'title': 'Patient Global Impression of Severity (PGI-S) Questionnaire', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-17', 'size': 330033, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-26T11:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2019-09-16', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2014-11-11', 'dispFirstSubmitQcDate': '2019-09-16', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2014-11-13', 'dispFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-27', 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events', 'timeFrame': '24 months', 'description': 'Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.'}, {'measure': 'Volume of Post-void Residual (PVR) Urine', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.'}, {'measure': 'Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.'}, {'measure': 'Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL.'}, {'measure': 'Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.'}, {'measure': 'Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.'}, {'measure': 'Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit.'}, {'measure': 'Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 1-Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, and 7-Very much worse. Percentages of participants in each category were determined at each visit.'}, {'measure': 'Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire', 'timeFrame': 'Baseline, 1, 3, 6, and 12 months', 'description': 'SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary Incontinence, Stress', 'Tissue Therapy (Cell Therapy)'], 'conditions': ['Urinary Incontinence', 'Stress', 'Urination Disorders', 'Urologic Diseases', 'Lower Urinary Tract Symptoms', 'Urological Manifestations']}, 'descriptionModule': {'briefSummary': 'To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.', 'detailedDescription': 'This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,\n* Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,\n* SUI severity should be ≥10 g and \\<400 g of urine leakage over 24 hours,\n* Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.\n\nExclusion Criteria:\n\n* Symptoms of only urge urinary incontinence,\n* Symptoms of stress urinary incontinence prior to prostate surgery,\n* Routinely has more than 2 episodes of awakening to void during normal sleeping hours,\n* Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,\n* Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,\n* Symptoms of overflow incontinence\n* Additional medical restrictions as specified in the Clinical Investigation Plan,\n* Additional anatomical restrictions as specified in the Clinical Investigation Plan.'}, 'identificationModule': {'nctId': 'NCT02291432', 'briefTitle': 'Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook MyoSite'}, 'officialTitle': 'Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells', 'orgStudyIdInfo': {'id': '13-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMDC-USR', 'description': 'Cell treatment', 'interventionNames': ['Biological: autologous muscle-derived cells (AMDC)']}], 'interventions': [{'name': 'autologous muscle-derived cells (AMDC)', 'type': 'BIOLOGICAL', 'description': 'Cell treatment', 'armGroupLabels': ['AMDC-USR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'McKay Urology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kenneth Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaumont Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook MyoSite', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}