Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-25 @ 3:00 AM
Study NCT ID:
NCT01799902
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in I-PSS storage scores (frequency, urgency, nocturia)', 'timeFrame': 'Baseline, Week 6 and 12', 'description': 'To evaluate the effect of solifenacin monotherapy or combination with an α receptor blocker on storage symptoms measured by the patient I-PSS (International Prostate Symptom Score questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours', 'timeFrame': 'Baseline, Week 6 and 12'}, {'measure': 'Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours', 'timeFrame': 'Baseline, Week 6 and 12'}, {'measure': 'Change in Storage symptoms assessed in the patient bladder diary by Mean number of urgency (grade 3 or 4, Patient Perception of Intensity of Urgency Scale (PPIUS)) episodes per 24 hours', 'timeFrame': 'Baseline, Week 6 and 12'}, {'measure': 'Change in Storage symptoms assessed in the patient bladder diary by Mean number of urge incontinence (grade 4, PPIUS) episodes per 24 hours', 'timeFrame': 'Baseline, Week 6 and 12'}, {'measure': 'Voiding scores (incomplete emptying, intermittency, weak stream and straining)', 'timeFrame': 'Week 1, 6 and 12'}, {'measure': 'Total and individual I-PSS item scores', 'timeFrame': 'Week 1, 6 and 12'}, {'measure': 'Quality Of Life assessed by the patient I-PSS questionnaire', 'timeFrame': 'Week 1, 6 and 12'}, {'measure': 'Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)', 'timeFrame': 'Week 1, 6 and 12'}, {'measure': 'Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)', 'timeFrame': 'Week 1, 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Observational', 'Non-Interventional Prospective', 'Phase IV Treatment', 'Overactive Bladder Syndrome', 'Solifenacin'], 'conditions': ['Lower Urinary Tract Predominant Storage Symptoms']}, 'descriptionModule': {'briefSummary': 'This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol.\n\nAfter standard evaluation the investigator will decide the treatment strategy and upon eligibility criteria met will propose subject to participate to the study. Informed consent will be collected for all subjects.\n\nThe study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow up).\n\nDuring all observational visits (V1, V2 and V3) the patient will complete the I-PSS (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL) questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual Analogue Scale (VAS).\n\nThe patient will be asked to complete a voiding diary the first 3 days after Visit 1 (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.\n\nProstate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and Trans Rectal Ultra Sound data will be collected only if available.\n\nDuring all observational visits (V1, V2 and V3) the investigator will complete the assessment of treatment benefit and satisfaction using a VAS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe following subjects can be included in this study if they answer the following criteria:\n\n* they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC).\n* Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator.\n* IPSS storage sub-score \\> 8\n* Subject expected to require at least 3 months treatment with solifenacin.\n\nExclusion Criteria:\n\n* Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).\n* History of bladder obstruction not being adequately corrected.\n* Anticipate or plan to participate in another study during study period of 12 weeks from study entry.'}, 'identificationModule': {'nctId': 'NCT01799902', 'acronym': 'VENICE', 'briefTitle': 'Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination', 'orgStudyIdInfo': {'id': 'BE-11-VES-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male subjects with LUT predominant storage symptoms (OAB)', 'description': 'male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination', 'interventionNames': ['Drug: Solifenacin']}], 'interventions': [{'name': 'Solifenacin', 'type': 'DRUG', 'otherNames': ['YM905, Vesicare®'], 'description': 'Oral', 'armGroupLabels': ['Male subjects with LUT predominant storage symptoms (OAB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'ASZ', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Stuyvenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1180', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Private practice', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2100', 'city': 'Deurne', 'country': 'Belgium', 'facility': 'AZ St. Monica', 'geoPoint': {'lat': 51.22134, 'lon': 4.46595}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Sint-Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '8400', 'city': 'Ostend', 'country': 'Belgium', 'facility': 'AZ Damiaan', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}, {'zip': '9700', 'city': 'Oudenaarde', 'country': 'Belgium', 'facility': 'AZ Oudenaarde', 'geoPoint': {'lat': 50.85168, 'lon': 3.60891}}, {'zip': '8800', 'city': 'Roeselaere', 'country': 'Belgium', 'facility': 'H.Hart Roeselaere'}, {'zip': '9620', 'city': 'Zottegem', 'country': 'Belgium', 'facility': 'AZ Sint Elisabeth', 'geoPoint': {'lat': 50.86955, 'lon': 3.81052}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Veeda Clinical Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}