The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
303
propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
placebo corresponding to body weight
voiding frequency
Time frame: before therapy and at end of therapy
voided volume
Time frame: before and at end of treatment
incontinence episodes per day
Time frame: before and at end of therapy
safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate
Time frame: before and at end of treatment
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