A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Overactive Bladder, Urinary Incontinence, Urge Incontinence

Intervention / Treatment
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* Drug: Solifenacin succinate
* Behavioral: Simplified bladder training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months Exclusion Criteria: Clinically significant outflow obstruction 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Solifenacin succinate | Drug: Solifenacin succinate<br>* tablet<br>* Other names: YM905;|
| Experimental: 2<br>Solifenacin succinate and simplified bladder training | Behavioral: Simplified bladder training<br>* Instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of micturitions per 24 hours after 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frequency, treatment outcomes, Overactive bladder, Solifenacin succinate, urinary incontinence, urge incontinence