Trial | NCT00603343  Report issue

Title

Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    propiverine ...

  • Study Participants

    303
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 Started
Jun 30
2004
Primary Completion
Sep 30
2006
Study Completion
Dec 31
2006
Last Update
Jan 29
2008
Estimate

Drug Mictonetten 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)

  • Other names: Mictonetten

Drug placebo

placebo corresponding to body weight

1 Active Comparator

2 Placebo Comparator

Criteria 

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
No Results Posted