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

Primary Purpose

Overactive Bladder, Urinary Incontinence, Children

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mictonetten 5 mg, coated tablet
placebo
Sponsored by
APOGEPHA Arzneimittel GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    voiding frequency

    Secondary Outcome Measures

    voided volume
    incontinence episodes per day
    safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate

    Full Information

    First Posted
    January 16, 2008
    Last Updated
    January 16, 2008
    Sponsor
    APOGEPHA Arzneimittel GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00603343
    Brief Title
    Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    September 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    APOGEPHA Arzneimittel GmbH

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder, Urinary Incontinence, Children
    Keywords
    antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    303 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Mictonetten 5 mg, coated tablet
    Other Intervention Name(s)
    Mictonetten
    Intervention Description
    propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo corresponding to body weight
    Primary Outcome Measure Information:
    Title
    voiding frequency
    Time Frame
    before therapy and at end of therapy
    Secondary Outcome Measure Information:
    Title
    voided volume
    Time Frame
    before and at end of treatment
    Title
    incontinence episodes per day
    Time Frame
    before and at end of therapy
    Title
    safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate
    Time Frame
    before and at end of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniela Marschall-Kehrel, MD
    Organizational Affiliation
    urologist
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18502028
    Citation
    Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, Strugala G. Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7.
    Results Reference
    derived

    Learn more about this trial

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

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