Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT01876706
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2013-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Monica.Ransom@Teleflex.com', 'phone': '4159648770', 'title': 'Monica Ransom Director of Clinical Operations', 'organization': 'NeoTract'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 Years;', 'description': 'AEs reported from Index Procedure through 5 Year follow-up; No UADEs; No device or related SAEs', 'eventGroups': [{'id': 'EG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 47, 'seriousNumAtRisk': 51, 'deathsNumAffected': 3, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 44, 'numAffected': 42}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 46, 'numAffected': 37}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urge Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.a'}], 'seriousEvents': [{'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastatic melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': '90 - 100 Score', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': '80 - 89 Score', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Month', 'description': 'Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IPSS Scores at Baseline and 12 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline IPSS', 'categories': [{'measurements': [{'value': '20.78', 'spread': '5.28', 'groupId': 'OG000'}]}]}, {'title': '12 Month IPSS', 'categories': [{'measurements': [{'value': '9.73', 'spread': '7.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.\n\nScore Correlation\\[1\\] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic', 'unitOfMeasure': 'IPSS total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IPSS 12 Month Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '11.05', 'spread': '7.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.\n\nThe larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IPSS 12 Month Percent (%) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '43.1', 'upperLimit': '63.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.\n\nThe larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject.', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BPH II Scores at Baseline and 12 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline BPHII', 'categories': [{'measurements': [{'value': '6.32', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': '12 Month BPHII', 'categories': [{'measurements': [{'value': '1.71', 'spread': '2.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.', 'unitOfMeasure': 'BPHII total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BPH II 12 Month Percent (%) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '82.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BPH II 12 Month Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '4.61', 'spread': '3.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.', 'unitOfMeasure': 'BPHII total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Qmax Scores at Baseline and 12 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline Qmax', 'categories': [{'measurements': [{'value': '8.33', 'spread': '2.07', 'groupId': 'OG000'}]}]}, {'title': '12 Month Qmax', 'categories': [{'measurements': [{'value': '11.79', 'spread': '4.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QMAX maximum peak urinary flow rate, if valid void \\>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.'}, {'type': 'SECONDARY', 'title': 'QMAX 12 Month Change Minus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3.45', 'spread': '4.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QMAX maximum peak urinary flow rate, if valid void \\>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.'}, {'type': 'SECONDARY', 'title': 'QMAX 12 Month Percent (%) Change in mL/Sec From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '97.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'QMAX maximum peak urinary flow rate, if valid void \\>125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.'}, {'type': 'SECONDARY', 'title': 'Pain Tolerability Throughout the UroLift System Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'During Flexible cystoscopy', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'After Rigid cystoscopy', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'During UroLift implant placement', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'After sheath removed (end of procedure)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pain Tolerability throughout the UroLift System Procedure'}, {'type': 'SECONDARY', 'title': 'BPHII Baseline and 12 Month Median Score, 95% CI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline BPHII', 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '7.28'}]}]}, {'title': '12 Month BPHII', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '2.43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Month', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.', 'unitOfMeasure': 'BPHII total score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IPSS at Baseline and 12 Months, Median , 95% CI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline IPSS score', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '19.11', 'upperLimit': '22.45'}]}]}, {'title': '12 Month IPSS score', 'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '7.38', 'upperLimit': '12.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Month', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.\n\nScore Correlation\\[1\\] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic', 'unitOfMeasure': 'IPSS total score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QMAX Median at Baseline and 12 Months With CI 95%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '7.60', 'upperLimit': '9.07'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.19', 'upperLimit': '13.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Month', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.', 'unitOfMeasure': 'mL/sec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': '1 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': '3 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': '6 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': '12 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': '24 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': '36 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': '48 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': '60 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'BPH Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawals', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'UroLift Arm', 'description': 'Subjects that undergo the UroLift System procedure'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '7.6', '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': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '48', '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': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2013-05-06', 'resultsFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-22', 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery', 'timeFrame': '1 Month', 'description': 'Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.'}], 'secondaryOutcomes': [{'measure': 'IPSS Scores at Baseline and 12 Month Follow-up', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.\n\nScore Correlation\\[1\\] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic'}, {'measure': 'IPSS 12 Month Change From Baseline', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.\n\nThe larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS.'}, {'measure': 'IPSS 12 Month Percent (%) Change From Baseline', 'timeFrame': '12 Months', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.\n\nThe larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject.'}, {'measure': 'BPH II Scores at Baseline and 12 Month Follow-up', 'timeFrame': '12 Month', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.'}, {'measure': 'BPH II 12 Month Percent (%) Change From Baseline', 'timeFrame': '12 Months', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.'}, {'measure': 'BPH II 12 Month Change From Baseline', 'timeFrame': '12 Months', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.'}, {'measure': 'Qmax Scores at Baseline and 12 Month Follow-up', 'timeFrame': '12 Month', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.'}, {'measure': 'QMAX 12 Month Change Minus Baseline', 'timeFrame': '12 Months', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX'}, {'measure': 'QMAX 12 Month Percent (%) Change in mL/Sec From Baseline', 'timeFrame': '12 Months', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject'}, {'measure': 'Pain Tolerability Throughout the UroLift System Procedure', 'timeFrame': '12 Month', 'description': 'Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.'}, {'measure': 'BPHII Baseline and 12 Month Median Score, 95% CI', 'timeFrame': '12 Month', 'description': 'BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.\n\nQuestions 1-4:\n\n1. Over the past month how much physical discomfort did any urinary problems cause you? \\&\n2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.\n3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.\n4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.'}, {'measure': 'IPSS at Baseline and 12 Months, Median , 95% CI', 'timeFrame': '12 Month', 'description': 'The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.\n\nScore Correlation\\[1\\] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic'}, {'measure': 'QMAX Median at Baseline and 12 Months With CI 95%', 'timeFrame': '12 Month', 'description': 'QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['UroLift System'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.', 'detailedDescription': 'The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)\n\nExclusion Criteria:\n\n* Size, volume,length of prostate'}, 'identificationModule': {'nctId': 'NCT01876706', 'acronym': 'LOCAL', 'briefTitle': 'UroLift System TOlerability and ReCovery When Administering Local Anesthesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeoTract, Inc.'}, 'officialTitle': 'L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia', 'orgStudyIdInfo': {'id': 'CP12911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UroLift® System', 'description': 'Single-arm of qualified subjects receiving UroLift® System intervention.', 'interventionNames': ['Device: UroLift® System']}], 'interventions': [{'name': 'UroLift® System', 'type': 'DEVICE', 'description': 'The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.', 'armGroupLabels': ['UroLift® System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Research LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Pinellas Urology', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sheldon J. Freedman, M.D., Ltd.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Neal D Shore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grand Strand Urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeoTract, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}