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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
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
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
Chandler, Arizona, United States
Investigative Site
Mesa, Arizona, United States
Investigative Site
Sierra Vista, Arizona, United States
Investigative Site
Tempe, Arizona, United States
Investigative Site
Atherton, California, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Newport Beach, California, United States
Investigative Site
San Diego, California, United States
Investigative Site
Temecula, California, United States
...and 72 more locations