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| Name | Class |
|---|---|
| Astellas Pharma Europe B.V. | INDUSTRY |
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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.
Subjects are screened between day -14 and day -1.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Solifenacin succinate |
|
| 2 | Experimental | Solifenacin succinate and simplified bladder training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin succinate | Drug | tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean number of micturitions per 24 hours after 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean number of micturitions per 24 hours after 16 weeks | 16 weeks | |
| Change from baseline in mean urgency frequency per 24 hours | 8 and 16 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astellas Medical Affairs Europe | University Hospital, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kogarah | New South Wales | 2217 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19818077 | Background | 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. | |
| 37811598 | Derived |
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| Simplified bladder training |
| Behavioral |
Instructions |
|
| Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours |
| 8 and 16 weeks |
| Change from baseline in number of pads used | 8 and 16 weeks |
| Incidence and severity of adverse events | 8 and 16 weeks |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Auchenflower | Queensland | 4066 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Concord | Australia |
| Parkville | Australia |
| Antwerp | 2020 | Belgium |
| Brussels | 1090 | Belgium |
| Brussels | 1200 | Belgium |
| Ghent | 9000 | Belgium |
| Ghent | Belgium |
| Kortrijk | 8500 | Belgium |
| La Louvière | Belgium |
| Sint-Truiden | 3800 | Belgium |
| Jihlava | 586 01 | Czechia |
| Liberec | 460 63 | Czechia |
| Olomouc | 772 00 | Czechia |
| Pilsen | 326 00 | Czechia |
| Prague | 147 00 | Czechia |
| Annecy | France |
| Arras | France |
| Bordeaux | France |
| Landerneau | France |
| Marseille | France |
| Paris | France |
| Rouen | France |
| Saint-Louis | France |
| Thionville | France |
| Toulouse | 31400 | France |
| Valenciennes | France |
| Vernon | France |
| Budapest | H-1145 | Hungary |
| Budapest | Hungary |
| Kecskemét | Hungary |
| Nyíregyháza | H-4400 | Hungary |
| Tatabánya | Hungary |
| Bari | Italy |
| Cinisello Balsamo | Italy |
| Como | Italy |
| Genova | Italy |
| Milan | 20092 | Italy |
| Naples | Italy |
| Leiden | 2334 | Netherlands |
| Roermond | 6043 | Netherlands |
| Tilburg | 5022 | Netherlands |
| Zwijndrecht | 331 | Netherlands |
| Warsaw | 00-846 | Poland |
| Warsaw | 02-520 | Poland |
| Moscow | 101000 | Russia |
| Moscow | 117815 | Russia |
| Moscow | 119049 | Russia |
| Moscow | 119415 | Russia |
| Moscow | 125206 | Russia |
| Saint Petersburg | 197098 | 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) |
| 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. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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