Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
Phase 3
Completed
- Conditions
- Overactive BladderUrinary IncontinenceChildren
- Interventions
- Drug: Mictonetten 5 mg, coated tabletDrug: placebo
- Registration Number
- NCT00603343
- Lead Sponsor
- APOGEPHA Arzneimittel GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
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
Read More
Exclusion Criteria
- normal age expected bladder capacity
- PVR more than 10 ml
- dysfunctional voiding
- neurogenic disorders
- UTI, constipation
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Mictonetten 5 mg, coated tablet - 2 placebo -
- Primary Outcome Measures
Name Time Method voiding frequency before therapy and at end of therapy
- Secondary Outcome Measures
Name Time Method 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