Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2006

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

  • 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

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • voiding frequency
    • Time Frame: before therapy and at end of therapy

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • APOGEPHA Arzneimittel GmbH
  • Provider of Information About this Clinical Study
    • APOGEPHA, APOGEPHA Arzneimittel GmbH
  • Overall Official(s)
    • Daniela Marschall-Kehrel, MD, Principal Investigator, urologist

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