A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis
A clinical study to compare the efficacy and safety of solifenacin succinate in patients with neurogenic detrusor overactivity. In this randomized, double blind, double dummy study solifenacin will be compared to placebo and an active comparator, oxybutynin hydrochloride. Patients will be randomized to one of four treatment arms; solifenacin 10mg, solifenacin 5mg, placebo or oxybutynin 15mg. Patients will be assessed over a four week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
249
Oral, 10mg
Oral, 5mg
Oral, 15mg
Unnamed facility
Brisbane, Australia
Change from baseline in maximum cystometric capacity
Time frame: 4 Weeks
Change from baseline in bladder volume at first involuntary contraction
Time frame: 4 Weeks
Change from baseline in pressure at first leak
Time frame: 4 Weeks
Change from baseline in volume at first leak
Time frame: 4 Weeks
Change from baseline in maximum detrusor pressure
Time frame: 4 Weeks
Change from baseline in micturition or catheterization frequency
Time frame: 4 Weeks
Change from baseline in incontinence episodes
Time frame: 4 Weeks
Incidence and severity of adverse events
Time frame: 4 Weeks
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Oral
Unnamed facility
Melbourne, Australia
Unnamed facility
Perth, Australia
Unnamed facility
Randwick, Australia
Unnamed facility
Antwerp, Belgium
Unnamed facility
Esneux, Belgium
Unnamed facility
Fraiture-en-Condroz, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Melsbroek, Belgium
...and 29 more locations