Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:56 PM
Study NCT ID:
NCT01371994
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2011-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@us.astellas.com', 'title': 'Medical Director, Urology', 'organization': 'Astellas Pharma Global Development, Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data, or 18 months after data lock, whichever occurs first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.'}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.', 'otherNumAtRisk': 310, 'otherNumAffected': 2, 'seriousNumAtRisk': 310, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.', 'otherNumAtRisk': 313, 'otherNumAffected': 19, 'seriousNumAtRisk': 313, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthritis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infected Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Psoas Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bladder Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From First Dose to Urinary Continence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not observed during 12-week treatment period due to low incidence of continence events.', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not observed during 12-week treatment period due to low incidence of continence events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1745', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \\>3) at a 2-sided significance level of 0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \\> 3).'}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Gain Continence During 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4833', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison at Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mental-Haenszel test stratified by (pooled) center'}, {'pValue': '0.5761', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison at Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mental-Haenszel test stratified by (pooled) center'}, {'pValue': '0.0592', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mental-Haenszel test stratified by (pooled) center'}, {'pValue': '0.0390', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mental-Haenszel test stratified by (pooled) center'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. End of treatment is the last on-treatment assessment during the treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.'}, {'type': 'SECONDARY', 'title': 'Average Daily Pad Usage at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (7 days prior to Day 1)', 'description': 'Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.', 'unitOfMeasure': 'pads', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available pad usage data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Pad Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 4 (n=297, 302)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=280, 292)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=226, 226)', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=298, 302)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Comparison at Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of variance model including treatment and (pooled) center as fixed factors.'}, {'pValue': '0.0761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Comparison at Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of variance model including treatment and (pooled) center as fixed factors.'}, {'pValue': '0.0149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of variance model including treatment and (pooled) center as fixed factors.'}, {'pValue': '0.0325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of variance model including treatment and (pooled) center as fixed factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. End of treatment is the last on-treatment assessment during the treatment period.', 'unitOfMeasure': 'pads', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available pad usage data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'American Urology Association Symptom Score (AUASS) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '7.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available AUASS data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in American Urology Association Symptom Score (AUASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n=262, 277)', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=293, 307)', 'categories': [{'measurements': [{'value': '-7.4', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '1.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.4521', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '1.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). End of treatment is the last on-treatment assessment during the treatment period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available AUASS data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'American Urology Association Quality of Life (QOL) Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available AUA QOL data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in American Urology Association Quality of Life (QOL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n=261, 276)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=292, 306)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.1499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). End of treatment is the last on-treatment assessment during the treatment period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available AUA data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '4.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available ICIQ-SF QOL data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n=262, 277)', 'categories': [{'measurements': [{'value': '-5.7', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=292, 307)', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1279', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '1.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.1038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '1.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available ICIQ-SF data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '46.22', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '45.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.', 'unitOfMeasure': 'percent work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n= 81, 88)', 'categories': [{'measurements': [{'value': '-37.9', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-37.6', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=88, 102)', 'categories': [{'measurements': [{'value': '-36.8', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-34.4', 'spread': '2.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8876', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-4.19', 'ciUpperLimit': '3.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.3950', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-8.10', 'ciUpperLimit': '3.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.86', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'Percent work time missed', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '30.05', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '29.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.", 'unitOfMeasure': 'percent impairment while working', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n=66, 80)', 'categories': [{'measurements': [{'value': '-21.8', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-23.8', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=72, 91)', 'categories': [{'measurements': [{'value': '-20.8', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-21.8', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '6.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.43', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.6959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-3.92', 'ciUpperLimit': '5.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.47', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'percent impairment while working', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '35.26', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '33.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.", 'unitOfMeasure': 'percent overall work impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n= 59, 69)', 'categories': [{'measurements': [{'value': '-30.4', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-33.7', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=65, 79)', 'categories': [{'measurements': [{'value': '-30.0', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-31.1', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-2.26', 'ciUpperLimit': '8.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.81', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.6980', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-4.50', 'ciUpperLimit': '6.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.83', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'percent overall work impairment', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '28.38', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '27.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.", 'unitOfMeasure': 'percent activity impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available WPAI data at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'title': 'Week 12 (n=115, 129)', 'categories': [{'measurements': [{'value': '-28.2', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-30.2', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment (n=124, 145)', 'categories': [{'measurements': [{'value': '-28.4', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-28.8', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '6.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.46', 'groupDescription': 'Comparison at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}, {'pValue': '0.8507', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-4.21', 'ciUpperLimit': '5.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.36', 'groupDescription': 'Comparison of end of treatment analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'Percent activity impairment', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available WPAI data at both Baseline and each time point; "n" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Time From Baseline to First Day of Returning to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '12.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.2700', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on a Log-rank test stratified by (pooled) center.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Week 12', 'description': 'The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed prior to the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'FG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '320'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '278'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Randomized but Never Received Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study population consisted of male patients \\> 18 years of age who were diagnosed with prostate cancer, treated by robotic assisted radical prostatectomy (RARP) and had urinary incontinence for 1 week following removal of the indwelling catheter.', 'preAssignmentDetails': 'Participants meeting the Baseline criteria were randomized 1:1 to 5 mg solifenacin succinate or matching placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.'}, {'id': 'BG001', 'title': 'Solifenacin Succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '6.72', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '7.21', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '6.98', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set, defined as all participants who took at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2013-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2011-06-10', 'resultsFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-06', 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From First Dose to Urinary Continence', 'timeFrame': '12 weeks', 'description': 'Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Gain Continence During 12-week Treatment Period', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. End of treatment is the last on-treatment assessment during the treatment period.'}, {'measure': 'Average Daily Pad Usage at Baseline', 'timeFrame': 'Baseline (7 days prior to Day 1)', 'description': 'Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.'}, {'measure': 'Change From Baseline in Average Daily Pad Usage', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. End of treatment is the last on-treatment assessment during the treatment period.'}, {'measure': 'American Urology Association Symptom Score (AUASS) at Baseline', 'timeFrame': 'Baseline', 'description': 'Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).'}, {'measure': 'Change From Baseline in American Urology Association Symptom Score (AUASS)', 'timeFrame': 'Baseline and Week 12', 'description': 'Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). End of treatment is the last on-treatment assessment during the treatment period.'}, {'measure': 'American Urology Association Quality of Life (QOL) Score at Baseline', 'timeFrame': 'Baseline', 'description': 'The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).'}, {'measure': 'Change From Baseline in American Urology Association Quality of Life (QOL) Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). End of treatment is the last on-treatment assessment during the treatment period.'}, {'measure': 'International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline', 'timeFrame': 'Baseline', 'description': 'The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).'}, {'measure': 'Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).'}, {'measure': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'timeFrame': 'Baseline', 'description': 'Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed', 'timeFrame': 'Baseline and Week 12', 'description': 'Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.'}, {'measure': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity."}, {'measure': 'Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement."}, {'measure': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity."}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement."}, {'measure': 'Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'timeFrame': 'Baseline', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity."}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment', 'timeFrame': 'Baseline and Week 12', 'description': "Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement."}, {'measure': 'Time From Baseline to First Day of Returning to Work', 'timeFrame': 'From Baseline to Week 12', 'description': 'The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radical Robotic Arm', 'Vesicare', 'Post Prostatectomy Incontinence', 'YM905'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=253', 'label': 'Link to results on the Astellas Clinical Study Results website.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.\n\nThis study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.', 'detailedDescription': 'The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.\n\nParticipants will complete an electronic daily pad use diary during the study\n\nduration. Participants will also be asked to complete several questionnaires during the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory\n* Willing and able to complete the daily pad use diary,\n\nAmerican Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)\n\n* Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment\n* Diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days\n\nExclusion Criteria:\n\n* Evidence of severe neurologic damage post-prostatectomy\n* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder\n* Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.\n* Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance \\< 30 ml/min)\n* History of diagnosed gastrointestinal obstruction disease\n* Any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct\n* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics\n* Treated with any investigational drug within last 30 days\n* History of a clinically significant illness or medical condition that would preclude participation in the study\n* Diagnosed with New York Heart Association Class III and IV heart failure\n* Any of the following peri-operative laboratory results: ALT \\> 2.0 ULN, AST \\> 2.0 ULN, serum creatinine \\> 1.5 mg/L, blood glucose \\> 130 mg/dL, blood urea nitrogen (BUN) \\> 23 mg/dL.\n* Severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure \\> 180 mmHg and/or diastolic blood pressure \\> 110 mmHg, and which is not corrected\n* Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization\n* Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening.'}, 'identificationModule': {'nctId': 'NCT01371994', 'briefTitle': 'A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': '905-UC-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solifenacin succinate', 'description': 'Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.', 'interventionNames': ['Drug: solifenacin succinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo tablets once a day for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'solifenacin succinate', 'type': 'DRUG', 'otherNames': ['Vesicare', 'YM905'], 'description': 'oral', 'armGroupLabels': ['Solifenacin succinate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Clinical Research Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Urological Associates of Southern Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento Medical Group, Inc.', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Center of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Associates', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Urology', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '06762', 'city': 'Middlebury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Clinical Research Center', 'geoPoint': {'lat': 41.52787, 'lon': -73.12761}}, {'zip': '06052', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Grove Hill Medical Center', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Urologic Surgeons of Washington', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Research Network', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Winter Park Urology Associates', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Southeastern Research Group', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northeast Indiana Research', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Urology of Indiana', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Iowa Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University School of Medicine, Department of Urology', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Medical Group', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '56377', 'city': 'Sartell', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Adult and Pediatric Urology Group', 'geoPoint': {'lat': 45.62163, 'lon': -94.20694}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Five Valley Urology', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'South Nevada Aids Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AdvanceMed Research', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08043', 'city': 'Mount Laurel', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology', 'geoPoint': {'lat': 39.934, 'lon': -74.891}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Community Care Physicians PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Urology Research Group', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'University Urology Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Hudson Valley Urology, PC', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'AMP Urology', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Urology', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Associated Urologists of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Urology Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43615', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Romius Institute of Northwest Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Urologic Consultants of Southeastern Pennsylvania', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '02915', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pharma Resources', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Academic Urologists', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Volunteer Research Group', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeast Urology Network', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77094', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Urology Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Urology Group', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Institute Clinical Trial Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'V5Z IM9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'The Prostate Centre, Diamond Health Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network/ Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}