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

NCT ID: NCT00603343

Last Updated: 2008-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

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This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Conditions

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Overactive Bladder Urinary Incontinence Children

Keywords

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antimuscarinics children overactive bladder propiverine urinary incontinence urotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Mictonetten 5 mg, coated tablet

Intervention Type DRUG

propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo corresponding to body weight

Interventions

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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)

Intervention Type DRUG

placebo

placebo corresponding to body weight

Intervention Type DRUG

Other Intervention Names

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Mictonetten

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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APOGEPHA Arzneimittel GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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APOGEPHA Arzneimittel GmbH

Principal Investigators

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Daniela Marschall-Kehrel, MD

Role: PRINCIPAL_INVESTIGATOR

urologist

References

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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.

Reference Type DERIVED
PMID: 18502028 (View on PubMed)

Other Identifiers

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EudraCT-Number 200400124330

Identifier Type: -

Identifier Source: org_study_id