The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Placebo tablet once daily with sham titration
Scott Department of Urology Baylor College of Medicine
Houston, Texas, United States
Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.
Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
Safety and tolerability.
Quality of life at week 6 and/or 12.
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