Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
- Registration Number
- NCT00366002
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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• Symptoms of OAB for at least six months prior to randomization
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≥ 8 micturitions on average/24 hours
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≥ 1 urgency episodes on average/24 hours
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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
-
-
• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Darifenacin Darifenacin
- Primary Outcome Measures
Name Time Method Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Investigative Site
🇺🇸Milwaukee, Wisconsin, United States
Investigative Site🇺🇸Milwaukee, Wisconsin, United States