Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00337558
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2006-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 643}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2006-06-14', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean number of micturitions per 24 hours after 8 weeks', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean number of micturitions per 24 hours after 16 weeks', 'timeFrame': '16 weeks'}, {'measure': 'Change from baseline in mean urgency frequency per 24 hours', 'timeFrame': '8 and 16 weeks'}, {'measure': 'Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours', 'timeFrame': '8 and 16 weeks'}, {'measure': 'Change from baseline in number of pads used', 'timeFrame': '8 and 16 weeks'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': '8 and 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment outcomes', 'Overactive bladder', 'Solifenacin succinate', 'urinary incontinence', 'urge incontinence', 'frequency'], 'conditions': ['Overactive Bladder', 'Urinary Incontinence', 'Urge Incontinence']}, 'referencesModule': {'references': [{'pmid': '19818077', 'type': 'BACKGROUND', 'citation': 'Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.'}, {'pmid': '37811598', 'type': 'DERIVED', 'citation': 'Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.', 'detailedDescription': 'Subjects are screened between day -14 and day -1.\n\nAt day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.\n\nThere are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)\n\nAll subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)\n\nSubjects randomized to bladder training will receive a single sheet of instructions for bladder training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\\> 3 months\n\nExclusion Criteria:\n\n* Clinically significant outflow obstruction\n* Significant post void residual volume\n* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.\n* Patient with a neurological cause for abnormal detrusor activity.\n* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs'}, 'identificationModule': {'nctId': 'NCT00337558', 'acronym': 'SOLAR', 'briefTitle': 'A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study', 'orgStudyIdInfo': {'id': '905-EC-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Solifenacin succinate', 'interventionNames': ['Drug: Solifenacin succinate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Solifenacin succinate and simplified bladder training', 'interventionNames': ['Behavioral: Simplified bladder training']}], 'interventions': [{'name': 'Solifenacin succinate', 'type': 'DRUG', 'otherNames': ['YM905'], 'description': 'tablet', 'armGroupLabels': ['1']}, {'name': 'Simplified bladder training', 'type': 'BEHAVIORAL', 'description': 'Instructions', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 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