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

January 16, 2008 updated by: APOGEPHA Arzneimittel GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
placebo corresponding to body weight
Active Comparator: 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
voiding frequency
Time Frame: before therapy and at end of therapy
before therapy and at end of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
voided volume
Time Frame: before and at end of treatment
before and at end of treatment
incontinence episodes per day
Time Frame: before and at end of therapy
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
before and at end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

APOGEPHA Arzneimittel GmbH

Investigators

  • Principal Investigator: Daniela Marschall-Kehrel, MD, Urologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT-Number 200400124330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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