NCT00238680

Brief Summary

The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

1.5 years

First QC Date

October 12, 2005

Last Update Submit

June 13, 2008

Conditions

Overactive BladderUrinary Incontinence

Keywords

Overactive bladderChildrenBladder rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.

Secondary Outcomes (1)

  • Bladder capacity measure before and after treatment.

Interventions

Bladder rehabilitationBEHAVIORAL
Bladder rehabilitation with programmable timerBEHAVIORAL

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
  • More than 6 voidings per day
  • Informed consent

You may not qualify if:

  • Known diseases of the kidneys or urinary tract besides OAB
  • Receiving treatment with drugs that have an effect on the urine production or bladder function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pediatrics, University hospital of Aarhus, Skejby Sygehus

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

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

  • Soeren Hagstroem, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2006

Study Completion

April 1, 2007

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

DK(1)