NCT00603343

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: APOGEPHA Arzneimittel GmbH · Industry
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder
• Urinary Incontinence
• Children

Interventions

Type	Name	Description
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)
DRUG	placebo	placebo corresponding to body weight

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-09-01
• Completion: 2006-12-01
• First posted: 2008-01-29
• Last updated: 2008-01-29