Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT00696761
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2008-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}], 'ancestors': [{'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'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': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047638', 'term': 'alfuzosin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mschoo@amc.seoul.kr', 'phone': '82-2-3010-3735', 'title': 'Kanghyon Song, Myung-Soo Choo, Kyu-Sung Lee, Ji-Yeon Han, Young-Suk Lee,', 'organization': 'the Department of Urology, Asan Medical Center, University of Ulsan College'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Patients were not divided into three groups according to the ICS nomogram (obstructed \\[BOOI \\<40\\], equivocally obstructed (20 \\<BOOI \\<40), and unobstructed \\[BOOI \\<20\\]).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100)\n\nalfuzosin : 10mg, once daily, 12months', 'otherNumAtRisk': 41, 'otherNumAffected': 2, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12 months', 'otherNumAtRisk': 54, 'otherNumAffected': 2, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'group1', 'description': 'BOOI≥ 20, BCI≥ 100\n\nalfuzosin : 10mg, once daily, 12months', 'otherNumAtRisk': 61, 'otherNumAffected': 2, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12months', 'otherNumAtRisk': 76, 'otherNumAffected': 3, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3.9'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BOOI≥ 20, BCI≥100', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nalfuzosin: 10mg, once daily, 12months'}, {'id': 'OG001', 'title': 'BOOI≥ 20, BCI<100', 'description': 'BOOI≥ 20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nalfuzosin: 10mg, once daily, 12months'}, {'id': 'OG002', 'title': 'BOOI<20, BCI≥ 100', 'description': 'BOOI\\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nalfuzosin: 10mg, once daily, 12months'}, {'id': 'OG003', 'title': 'BOOI<20, BCI<100', 'description': 'BOOI\\<20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nalfuzosin: 10mg, once daily, 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '13.4', 'spread': '6.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '12months', 'description': 'international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome\n\nBaseline score minus 12-month score', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Efficacy Was Analyzed by Validated Symptom Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100)\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'OG001', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12 months'}, {'id': 'OG002', 'title': 'group1', 'description': 'BOOI≥ 20, BCI≥ 100\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'OG003', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12months'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '9.0', 'spread': '6.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': 'The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants receiving drug for 12 months'}, {'type': 'SECONDARY', 'title': 'Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'group1', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG001', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '6.4', 'groupId': 'OG002'}, {'value': '8.2', 'spread': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12months', 'description': 'Changes of International Continence Society (ICS)-male questionnaire (voiding sum) to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.\n\nRange 0-20, higher scores represent worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Peak Flow Rates on Uroflowmetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'group1', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG001', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '13.0', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.', 'unitOfMeasure': 'ml/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Residual Urine Volumes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'group1', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG001', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.\n\nAlfuzosin: 10mg, once daily, 12months'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '87', 'groupId': 'OG000'}, {'value': '37', 'spread': '45.2', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '31.7', 'spread': '35.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BOOI≥20, BCI≥ 100', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'FG001', 'title': 'BOOI≥20, BCI< 100', 'description': 'BOOI≥ 20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'FG002', 'title': 'BOOI<20, BCI≥ 100', 'description': 'BOOI\\<20, BCI≥ 100)\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'FG003', 'title': 'BOOI<20, BCI< 100', 'description': 'BOOI\\<20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants recruited from a specialty clinic at the Asan Medical Center, Samsung Medical Center,The Catholic University of Korea College of Medicine, Hallym University, Chuncheon, Korea for 12-month', 'preAssignmentDetails': '232 participants recruited; 276 screened, 44 excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 3', 'description': 'BOOI\\<20, BCI≥ 100)\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'BG001', 'title': 'Group 4', 'description': 'BOOI\\<20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12 months'}, {'id': 'BG002', 'title': 'group1', 'description': 'BOOI≥ 20, BCI≥ 100\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'BG003', 'title': 'group2', 'description': 'BOOI≥ 20, BCI\\<100\n\nalfuzosin : 10mg, once daily, 12months'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '0', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '5', 'groupId': 'BG003'}, {'value': '65.7', 'spread': '7.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'international prostate symptom score', 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '18.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '19.4', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '21.0', 'spread': '6.5', 'groupId': 'BG003'}, {'value': '19.5', 'spread': '6.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'higher values represent a worse outcome total score range (form 0 to 35)', 'unitOfMeasure': 'scores', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2008-06-11', 'resultsFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2008-06-12', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-15', 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment', 'timeFrame': '12months', 'description': 'international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome\n\nBaseline score minus 12-month score'}, {'measure': 'Treatment Efficacy Was Analyzed by Validated Symptom Scores.', 'timeFrame': '12 month', 'description': 'Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.'}], 'secondaryOutcomes': [{'measure': 'Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)', 'timeFrame': '12months', 'description': 'Changes of International Continence Society (ICS)-male questionnaire (voiding sum) to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.\n\nRange 0-20, higher scores represent worse outcomes.'}, {'measure': 'Changes of Peak Flow Rates on Uroflowmetry', 'timeFrame': '12 months', 'description': 'Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.'}, {'measure': 'Changes in Residual Urine Volumes', 'timeFrame': '12 months', 'description': 'Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LUTS', 'BPH', 'bladder outlet obstruction', 'bladder contractility'], 'conditions': ['BPH']}, 'descriptionModule': {'briefSummary': 'Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.\n\nIt is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.', 'detailedDescription': '1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility\n2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \\& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH\n* Patients satisfying all of the following:\n* Moderate to severe LUTS :\n* international prostate symptom score (IPSS)≥ 8\n* An enlarged prostate (≥25 mL)\n* Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)\n\nExclusion Criteria:\n\n* Post voided residual urine ≥ 200 mL\n* Patients performing catheterization\n* Urinary tract infection patients\n* Patients taking 5 alpha reductase inhibitor\n* Known hypersensitivity to alfuzosin\n* History of postural hypotension or syncope\n* Hypertension patients treated with other alpha1-blockers\n* Patients newly taking anticholinergic medication within 1 month\n* Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)\n* Renal insufficiency (s-Cr ≥ 2mg/dL)\n* Unstable angina pectoris\n* Uninvestigated hematuria\n* Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)\n* Interstitial cystitis patients\n* Severe concomitant condition threatening life.\n* Patient who is unable to make voiding diary\n* Bladder or prostate cancer patients\n* Patients receiving prostate or bladder surgery'}, 'identificationModule': {'nctId': 'NCT00696761', 'briefTitle': 'The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility', 'orgStudyIdInfo': {'id': 'L9990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group1', 'description': 'Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.', 'interventionNames': ['Drug: Alfuzosin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group2', 'description': 'BOOI≥ 20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.', 'interventionNames': ['Drug: Alfuzosin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 3', 'description': 'BOOI\\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.', 'interventionNames': ['Drug: Alfuzosin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 4', 'description': 'BOOI\\<20, BCI\\<100 Alfuzosin was administered daily (10 mg) for 12 month.', 'interventionNames': ['Drug: Alfuzosin']}], 'interventions': [{'name': 'Alfuzosin', 'type': 'DRUG', 'otherNames': ['xatral'], 'description': '10mg, once daily, 12months', 'armGroupLabels': ['group1']}, {'name': 'Alfuzosin', 'type': 'DRUG', 'otherNames': ['xatral'], 'description': '10mg, once daily, 12months', 'armGroupLabels': ['group2']}, {'name': 'Alfuzosin', 'type': 'DRUG', 'otherNames': ['xatral'], 'description': '10mg, once daily, 12months', 'armGroupLabels': ['group 3']}, {'name': 'Alfuzosin', 'type': 'DRUG', 'otherNames': ['xatral'], 'description': '10mg, once daily, 12months', 'armGroupLabels': ['group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Myung-Soo Choo, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'urology department', 'investigatorFullName': 'Myung-Soo Choo', 'investigatorAffiliation': 'Asan Medical Center'}}}}