The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
Unnamed facility
Emmendingen, Baden-Wurttemberg, Germany
Unnamed facility
Heidelberg, Baden-Wurttemberg, Germany
Unnamed facility
Lahr, Baden-Wurttemberg, Germany
Change from baseline in volume at first detrusor contraction as determined by urodynamics
Time frame: At week 4
Detrusor pressure at first contraction
Time frame: At week 4
Volume at first detectable leakage
Time frame: At week 4
Volume at 10/20/30/40 cm H2O
Time frame: At week 4
Compliance
Time frame: At week 4
Maximum cystometric bladder capacity
Time frame: At week 4
7-day micturition diary: Micturitions
Time frame: At days 0, 14, 28
7-day micturition diary: Urgency episodes
Time frame: At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes
Time frame: At days 0, 14, 28
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Unnamed facility
Tübingen, Baden-Wurttemberg, Germany
Unnamed facility
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Unnamed facility
Planegg, Bavaria, Germany
Unnamed facility
Hamburg, Hamburg, Germany
Unnamed facility
Oberursel, Hesse, Germany
Unnamed facility
Herne, North Rhine-Westphalia, Germany
Unnamed facility
Mönchengladbach, North Rhine-Westphalia, Germany
...and 5 more locations