A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
NCT ID: NCT00337558
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
643 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
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Detailed Description
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At 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.
There 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)
All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)
Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Solifenacin succinate
Solifenacin succinate
tablet
2
Solifenacin succinate and simplified bladder training
Simplified bladder training
Instructions
Interventions
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Solifenacin succinate
tablet
Simplified bladder training
Instructions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant post void residual volume
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
* Patient with a neurological cause for abnormal detrusor activity.
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Astellas Medical Affairs Europe
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lund, Sweden
Locations
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Kogarah, New South Wales, Australia
Randwick, New South Wales, Australia
Auchenflower, Queensland, Australia
Clayton, Victoria, Australia
Concord, , Australia
Parkville, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
La Louvière, , Belgium
Sint-Truiden, , Belgium
Jihlava, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Annecy, , France
Arras, , France
Bordeaux, , France
Landerneau, , France
Marseille, , France
Paris, , France
Rouen, , France
Saint-Louis, , France
Thionville, , France
Toulouse, , France
Valenciennes, , France
Vernon, , France
Budapest, , Hungary
Budapest, , Hungary
Kecskemét, , Hungary
Nyíregyháza, , Hungary
Tatabánya, , Hungary
Bari, , Italy
Cinisello Balsamo, , Italy
Como, , Italy
Genova, , Italy
Milan, , Italy
Naples, , Italy
Leiden, , Netherlands
Roermond, , Netherlands
Tilburg, , Netherlands
Zwijndrecht, , Netherlands
Warsaw, , Poland
Warsaw, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Avilés, , Spain
Burgos, , Spain
Madrid, , Spain
Manacor, , Spain
Marbella, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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905-EC-003
Identifier Type: -
Identifier Source: org_study_id
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