Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

Study Overview
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Brief Summary
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This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.

Official Title
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A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Drug: Darifenacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Symptoms of OAB for at least six months prior to randomization ≥ 8 micturitions on average/24 hours ≥ 1 urgency episodes on average/24 hours with or without UUIE Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken. Patients without prior darifenacin treatment Exclusion Criteria: • A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL as verified in the micturition diary for two consecutive days prior to Baseline Males with post-void residual (PVR) urinary volume >200 mL at Baseline Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator Other protocol-defined inclusion / exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily<br>* Other names: Enablex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's perception of outcome using the PPBC questionnaire at Week 7. |  |  | 
| Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13. |  |  | 
| Assessment of efficacy of darifenacin with respect to change from baseline in: |  |  | 
| Number of micturitions per day at Weeks 7 and 13 |  |  | 
| Number of urgency episodes per day at Weeks 7 and 13 |  |  | 
| Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13 |  |  | 
| Assessment of safety and tolerability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist