Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:07 AM
Study NCT ID:
NCT01093534
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder 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': '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': 'Director Medical Affairs - Urology', 'organization': 'Astellas Pharma Europe Ltd.'}, '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. Sponsor must receive a site's manuscript at least 60 days prior to publication for review and comment. Sponsor may delay the publication for up to 6 months to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Company makes no warranties or representations of any kind as to the currency or completeness of 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': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.', 'otherNumAtRisk': 186, 'otherNumAffected': 9, 'seriousNumAtRisk': 186, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.', 'otherNumAtRisk': 182, 'otherNumAffected': 21, 'seriousNumAtRisk': 182, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.', 'otherNumAtRisk': 175, 'otherNumAffected': 34, 'seriousNumAtRisk': 175, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pancreatitis necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Endotoxic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Bladder Wall Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '1.28', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.169', 'ciLowerLimit': '-0.368', 'ciUpperLimit': '0.030', 'pValueComment': 'Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.', 'groupDescription': 'The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.'}, {'type': 'PRIMARY', 'title': 'Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '344', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.359', 'spread': '26.1760', 'groupId': 'OG000'}, {'value': '31.855', 'spread': '29.4371', 'groupId': 'OG001'}, {'value': '38.917', 'spread': '60.3231', 'groupId': 'OG002'}, {'value': '35.325', 'spread': '47.2694', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.', 'groupDescription': 'The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Nonparametric Wilcoxon rank-sum test does not adjust for other factors.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Nerve Growth Factor subset (FAS\\_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '342', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.564', 'spread': '23.0347', 'groupId': 'OG000'}, {'value': '30.135', 'spread': '47.4089', 'groupId': 'OG001'}, {'value': '34.199', 'spread': '56.2180', 'groupId': 'OG002'}, {'value': '32.143', 'spread': '51.9123', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Nerve Growth Factor subset (FAS\\_uNGF0) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '116.9', 'spread': '260.5', 'groupId': 'OG000'}, {'value': '158.1', 'spread': '483.0', 'groupId': 'OG001'}, {'value': '160.4', 'spread': '373.0', 'groupId': 'OG002'}, {'value': '159.2', 'spread': '431.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS\\_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '326', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'title': 'Week 6 (n=157, 145, 141, 286)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '1.21', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=160, 143, 135, 278)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '1.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6 and Week 12', 'description': 'Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data at each time point (indicated by n).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '344', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'title': 'Week 6 (n=168, 163, 160, 323)', 'categories': [{'measurements': [{'value': '-4.638', 'spread': '30.7301', 'groupId': 'OG000'}, {'value': '4.650', 'spread': '38.3159', 'groupId': 'OG001'}, {'value': '4.309', 'spread': '89.1963', 'groupId': 'OG002'}, {'value': '4.481', 'spread': '68.3171', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=173, 171, 166, 337)', 'categories': [{'measurements': [{'value': '-1.318', 'spread': '27.9927', 'groupId': 'OG000'}, {'value': '0.801', 'spread': '33.3120', 'groupId': 'OG001'}, {'value': '2.625', 'spread': '44.0319', 'groupId': 'OG002'}, {'value': '1.699', 'spread': '38.9150', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6 and Week 12', 'description': 'Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Nerve Growth Factor subset (FAS\\_uNGF0) participants with available data at each time point (indicated by n).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.40', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '3.55', 'groupId': 'OG001'}, {'value': '-1.80', 'spread': '2.63', 'groupId': 'OG002'}, {'value': '-2.13', 'spread': '3.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '257', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.58', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '-1.88', 'spread': '2.71', 'groupId': 'OG002'}, {'value': '-2.06', 'spread': '2.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits.', 'unitOfMeasure': 'urgency events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with events at Baseline and with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '3.77', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '2.61', 'groupId': 'OG002'}, {'value': '-1.55', 'spread': '3.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '247', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '2.99', 'groupId': 'OG001'}, {'value': '-1.60', 'spread': '2.45', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '2.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'urgency micturitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '-1.04', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '-1.24', 'spread': '1.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-0.90', 'spread': '1.23', 'groupId': 'OG002'}, {'value': '-1.09', 'spread': '1.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'urgency incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '1.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.', 'unitOfMeasure': 'urgency incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Level of Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.525', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.504', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.578', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.539', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Total Urgency Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '259', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.61', 'spread': '25.98', 'groupId': 'OG000'}, {'value': '-22.39', 'spread': '29.80', 'groupId': 'OG001'}, {'value': '-16.91', 'spread': '22.57', 'groupId': 'OG002'}, {'value': '-19.81', 'spread': '26.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '1.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Assessment of Urgency Bother', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.60', 'spread': '29.51', 'groupId': 'OG000'}, {'value': '-27.70', 'spread': '30.39', 'groupId': 'OG001'}, {'value': '-28.90', 'spread': '28.72', 'groupId': 'OG002'}, {'value': '-28.20', 'spread': '29.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Assessment of Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.90', 'spread': '42.18', 'groupId': 'OG000'}, {'value': '24.90', 'spread': '39.58', 'groupId': 'OG001'}, {'value': '31.90', 'spread': '41.02', 'groupId': 'OG002'}, {'value': '28.20', 'spread': '40.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The treatment satisfaction visual analog scale (TS\\_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'title': 'Mobility: Improvement', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}]}]}, {'title': 'Mobility: Worsening', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '5.3', 'groupId': 'OG003'}]}]}, {'title': 'Self-care: Improvement', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}]}]}, {'title': 'Self-care: Worsening', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}]}]}, {'title': 'Usual Activities: Improvement', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}, {'value': '9.3', 'groupId': 'OG003'}]}]}, {'title': 'Usual Activities: Worsening', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}, {'value': '8.0', 'groupId': 'OG003'}]}]}, {'title': 'Pain/Discomfort: Improvement', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}, {'value': '18.5', 'groupId': 'OG002'}, {'value': '18.9', 'groupId': 'OG003'}]}]}, {'title': 'Pain/Discomfort: Worsening', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}, {'value': '8.0', 'groupId': 'OG003'}]}]}, {'title': 'Anxiety/Depression: Improvement', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '19.9', 'groupId': 'OG002'}, {'value': '18.6', 'groupId': 'OG003'}]}]}, {'title': 'Anxiety/Depression: Worsening', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}, {'value': '13.7', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform). Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems. Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.60', 'spread': '16.86', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '20.22', 'groupId': 'OG001'}, {'value': '5.10', 'spread': '17.86', 'groupId': 'OG002'}, {'value': '4.90', 'spread': '19.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS). Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptom Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.90', 'spread': '19.11', 'groupId': 'OG000'}, {'value': '-22.32', 'spread': '20.59', 'groupId': 'OG001'}, {'value': '-22.91', 'spread': '18.69', 'groupId': 'OG002'}, {'value': '-22.60', 'spread': '19.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-Related Quality of Life (HRQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '11.72', 'spread': '16.71', 'groupId': 'OG000'}, {'value': '17.25', 'spread': '19.74', 'groupId': 'OG001'}, {'value': '17.69', 'spread': '15.75', 'groupId': 'OG002'}, {'value': '17.46', 'spread': '17.94', 'groupId': 'OG003'}]}]}, {'title': 'Coping subscale', 'categories': [{'measurements': [{'value': '12.40', 'spread': '18.85', 'groupId': 'OG000'}, {'value': '18.26', 'spread': '20.89', 'groupId': 'OG001'}, {'value': '20.21', 'spread': '19.42', 'groupId': 'OG002'}, {'value': '19.18', 'spread': '20.20', 'groupId': 'OG003'}]}]}, {'title': 'Concern subscale', 'categories': [{'measurements': [{'value': '13.80', 'spread': '18.64', 'groupId': 'OG000'}, {'value': '20.35', 'spread': '22.52', 'groupId': 'OG001'}, {'value': '20.77', 'spread': '18.73', 'groupId': 'OG002'}, {'value': '20.55', 'spread': '20.79', 'groupId': 'OG003'}]}]}, {'title': 'Sleep subscale', 'categories': [{'measurements': [{'value': '10.80', 'spread': '19.31', 'groupId': 'OG000'}, {'value': '15.50', 'spread': '21.33', 'groupId': 'OG001'}, {'value': '15.10', 'spread': '15.95', 'groupId': 'OG002'}, {'value': '15.30', 'spread': '18.95', 'groupId': 'OG003'}]}]}, {'title': 'Social interaction subscale', 'categories': [{'measurements': [{'value': '8.70', 'spread': '16.95', 'groupId': 'OG000'}, {'value': '13.00', 'spread': '19.65', 'groupId': 'OG001'}, {'value': '12.00', 'spread': '15.54', 'groupId': 'OG002'}, {'value': '12.50', 'spread': '17.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6). The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.4', 'spread': '317.6', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '426.9', 'groupId': 'OG001'}, {'value': '-88.1', 'spread': '980.6', 'groupId': 'OG002'}, {'value': '-27.8', 'spread': '754.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS\\_uBDNF); LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '342', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.962', 'spread': '24.2241', 'groupId': 'OG000'}, {'value': '2.758', 'spread': '49.0191', 'groupId': 'OG001'}, {'value': '3.858', 'spread': '44.0421', 'groupId': 'OG002'}, {'value': '3.302', 'spread': '46.5612', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.', 'unitOfMeasure': 'pg/µmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set urinary Nerve Growth Factor subset (FAS\\_uNGF0) participants with available data; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '324', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'OG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'OG003', 'title': 'Pooled Solifenacin', 'description': 'Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.'}], 'classes': [{'title': 'Deterioration', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '5.2', 'groupId': 'OG002'}, {'value': '5.9', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}, {'value': '20.3', 'groupId': 'OG002'}, {'value': '21.0', 'groupId': 'OG003'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000'}, {'value': '71.9', 'groupId': 'OG001'}, {'value': '74.5', 'groupId': 'OG002'}, {'value': '73.1', 'groupId': 'OG003'}]}]}, {'title': 'Major Improvement', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '42.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Bladder Wall Thickness (FAS\\_BWT) participants with available data; LOCF was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'FG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'Received Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '543', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '54.9', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '543', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '519', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set: all randomized participants who took at least 1 dose of the randomized study medication and for whom any data was reported after the first dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2012-07-18', 'completionDateStruct': {'date': '2011-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2010-03-24', 'dispFirstSubmitQcDate': '2012-08-31', 'resultsFirstSubmitDate': '2014-02-26', 'studyFirstSubmitQcDate': '2010-03-24', 'dispFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-26', 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Bladder Wall Thickness', 'timeFrame': 'Baseline and Week 12', 'description': 'Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.'}, {'measure': 'Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12', 'timeFrame': 'Week 12', 'description': 'Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}], 'secondaryOutcomes': [{'measure': 'Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12', 'timeFrame': 'Week 12', 'description': 'Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}, {'measure': 'Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12', 'timeFrame': 'Week 12', 'description': 'Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}, {'measure': 'Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness', 'timeFrame': 'Baseline, Week 6 and Week 12', 'description': 'Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.'}, {'measure': 'Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine', 'timeFrame': 'Baseline, Week 6 and Week 12', 'description': 'Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}, {'measure': 'Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours', 'timeFrame': '12 weeks', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits.'}, {'measure': 'Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours', 'timeFrame': 'Baseline and Week 12', 'description': 'An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.'}, {'measure': 'Change From Baseline to Week 12 in Mean Level of Urgency', 'timeFrame': 'Baseline and Week 12', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits.'}, {'measure': 'Change From Baseline to Week 12 in Total Urgency Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant.'}, {'measure': 'Change From Baseline in Patient Perception of Bladder Condition (PPBC)', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement."}, {'measure': 'Change From Baseline in Patient Assessment of Urgency Bother', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line. A negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Patient Assessment of Treatment Satisfaction', 'timeFrame': 'Baseline and Week 12', 'description': "The treatment satisfaction visual analog scale (TS\\_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement."}, {'measure': 'Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform). Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems. Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems."}, {'measure': 'Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale', 'timeFrame': 'Baseline and Week 12', 'description': "The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS). Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Symptom Bother Score', 'timeFrame': 'Baseline and Week 12', 'description': "Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement."}, {'measure': 'Change From Baseline in Health-Related Quality of Life (HRQL)', 'timeFrame': 'Baseline and Week 12', 'description': "Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6). The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement."}, {'measure': 'Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)', 'timeFrame': 'Baseline and Week 12', 'description': 'Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}, {'measure': 'Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine', 'timeFrame': 'Baseline and Week 12', 'description': 'Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations \\[pg/mL\\] by the urine creatinine concentrations (µmol/mL) from the same participant.'}, {'measure': 'Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)', 'timeFrame': 'Baseline and Week 12', 'description': "The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vesicare', 'Solifenacin', 'Detrusor Overactivity', 'Urinary Nerve Growth Factor', 'Overactive Bladder', 'Bladder wall thickness'], 'conditions': ['Detrusor Overactivity', 'Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '37160401', 'type': 'DERIVED', 'citation': 'Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=122', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.', 'detailedDescription': 'Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months\n* Urodynamic diagnosis of detrusor overactivity (DO)\n* Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit\n* Bladder post-void residual volume of less than 30 ml\n* Available to complete the study\n\nExclusion Criteria:\n\n* History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity\n* History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)\n* History of urinary tract operation within 6 months prior to screening\n* Indwelling catheter or permanent catheter fitted\n* History of pelvic area radiotherapy treatment\n* Uncontrolled diabetes mellitus\n* History of fibromyalgia\n* Post-partum or breast-feeding within 3 months prior to screening visit\n* Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)\n* Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening\n* History of drug and / or alcohol abuse at time of screening\n* History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions\n* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole\n* Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications\n* Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening\n* Participated in any clinical study less than or equal to 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT01093534', 'acronym': 'SHRINK', 'briefTitle': 'Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.', 'orgStudyIdInfo': {'id': '905-EC-007'}, 'secondaryIdInfos': [{'id': '2008-005215-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 2 placebo tablets once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Solifenacin 5 mg', 'description': 'Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: solifenacin']}, {'type': 'EXPERIMENTAL', 'label': 'Solifenacin 10 mg', 'description': 'Participants received two 5 mg solifenacin tablets once daily for 12 weeks.', 'interventionNames': ['Drug: solifenacin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching solifenacin placebo tablet', 'armGroupLabels': ['Placebo', 'Solifenacin 5 mg']}, {'name': 'solifenacin', 'type': 'DRUG', 'otherNames': ['YM905', 'Vesicare'], 'description': 'Tablet for oral administration', 'armGroupLabels': ['Solifenacin 10 mg', 'Solifenacin 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11530', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-4020', 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{'zip': '4809', 'city': 'Arendal', 'country': 'Norway', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'zip': '3004', 'city': 'Drammen', 'country': 'Norway', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '5507', 'city': 'Haugesund', 'country': 'Norway', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '3103', 'city': 'Tønsberg', 'country': 'Norway', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-530', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '00-846', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-432', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-929', 'city': 'Warsaw', 'country': 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