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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603343
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : January 29, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Incontinence Children Drug: Mictonetten 5 mg, coated tablet Drug: placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Mictonetten

Placebo Comparator: 2 Drug: placebo
placebo corresponding to body weight

Primary Outcome Measures :
  1. voiding frequency [ Time Frame: before therapy and at end of therapy ]

Secondary Outcome Measures :
  1. voided volume [ Time Frame: before and at end of treatment ]
  2. incontinence episodes per day [ Time Frame: before and at end of therapy ]
  3. safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate [ Time Frame: before and at end of treatment ]

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603343

Sponsors and Collaborators
APOGEPHA Arzneimittel GmbH
Principal Investigator: Daniela Marschall-Kehrel, MD urologist

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: APOGEPHA, APOGEPHA Arzneimittel GmbH Identifier: NCT00603343     History of Changes
Other Study ID Numbers: EudraCT-Number 200400124330
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008

Keywords provided by APOGEPHA Arzneimittel GmbH:
overactive bladder
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents