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

This study has been completed.
Sponsor:
Information provided by:
APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00603343
First received: January 16, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention Phase
Overactive Bladder
Urinary Incontinence
Children
 Drug: Mictonetten 5 mg, coated tablet
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by APOGEPHA Arzneimittel GmbH:

Primary Outcome Measures:
  • voiding frequency [ Time Frame: before therapy and at end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • voided volume [ Time Frame: before and at end of treatment ] [ Designated as safety issue: No ]
  • incontinence episodes per day [ Time Frame: before and at end of therapy ] [ Designated as safety issue: No ]
  • safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate [ Time Frame: before and at end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 303
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603343

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

No publications provided by APOGEPHA Arzneimittel GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: APOGEPHA, APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00603343     History of Changes
Other Study ID Numbers: EudraCT-Number 200400124330
Study First Received: January 16, 2008
Last Updated: January 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: Ministry of Public Health
Slovakia: State Institute for Drug Control
Sweden: The National Board of Health and Welfare

Keywords provided by APOGEPHA Arzneimittel GmbH:
antimuscarinics
children
overactive bladder
 propiverine
urinary incontinence
urotherapy

Additional relevant MeSH terms:
Urinary Incontinence
Stress, Psychological
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Urinary Bladder Diseases
Propiverine
 Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013