Children, Overactive Bladder, Urinary Incontinence
Conditions
Keywords
antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy
Brief summary
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.
Detailed description
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
Interventions
DRUGMictonetten 5 mg, coated tablet
propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
DRUGplacebo
placebo corresponding to body weight
Sponsors
APOGEPHA Arzneimittel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* voiding frequency 8 or above per day * at least one incontinence episode per day * age between 5-10 years * body weight between 17 and 45 kg
Exclusion criteria
* normal age expected bladder capacity * PVR more than 10 ml * dysfunctional voiding * neurogenic disorders * UTI, constipation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| voiding frequency | before therapy and at end of therapy |
Secondary
| Measure | Time frame |
|---|---|
| voided volume | before and at end of treatment |
| incontinence episodes per day | before and at end of therapy |
| safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate | before and at end of treatment |
Outcome results
None listed