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

Sponsored by:	APOGEPHA Arzneimittel GmbH
Information provided by:	APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier:	NCT00603343

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 III

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Mictonorm Propiverine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Active Comparator	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)
2: Placebo Comparator	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

Responsible Party:	APOGEPHA Arzneimittel GmbH ( APOGEPHA )
Study ID Numbers:	EudraCT-Number 200400124330
Study First Received:	January 16, 2008
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00603343
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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Propiverine
Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence

Additional relevant MeSH terms:

Parasympatholytics
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Autonomic Agents
Physiological Effects of Drugs
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009