NCT00603343

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

Enrollment Period

2.3 years

First QC Date

January 16, 2008

Last Update Submit

January 16, 2008

Conditions

Overactive BladderUrinary IncontinenceChildren

Keywords

antimuscarinicschildrenoveractive bladderpropiverineurinary incontinenceurotherapy

Outcome Measures

Primary Outcomes (1)

  • voiding frequency

    before therapy and at end of therapy

Secondary Outcomes (3)

  • voided volume

    before and at end of treatment

  • incontinence episodes per day

    before and at end of therapy

  • safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate

    before and at end of treatment

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Mictonetten 5 mg, coated tablet

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

Mictonetten 5 mg, coated tabletDRUG

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

Also known as: Mictonetten
1
placeboDRUG

placebo corresponding to body weight

2

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • normal age expected bladder capacity
  • PVR more than 10 ml
  • dysfunctional voiding
  • neurogenic disorders
  • UTI, constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18502028DERIVED

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

propiverine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Study Officials

  • Daniela Marschall-Kehrel, MD

    urologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

June 1, 2004

Primary Completion

September 1, 2006

Study Completion

December 1, 2006

Last Updated

January 29, 2008

Record last verified: 2008-01