Programmable Timer in the Bladder Rehabilitation Treatment of OAB

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00238680
First received: October 12, 2005
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention
Overactive Bladder
Urinary Incontinence
Behavioral: Bladder rehabilitation
Behavioral: Bladder rehabilitation with programmable timer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

Secondary Outcome Measures:
  • Bladder capacity measure before and after treatment.

Estimated Enrollment: 100
Study Start Date: March 2005
Study Completion Date: April 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.

The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.

When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.

Hypothesis:

  • Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation
  • The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment.

Material and methods:

100 children with idiopathic OAB will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.

After a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer.

The effect of the treatment will be estimated based on home recordings.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238680

Locations
Denmark
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Soeren Hagstroem, MD University of Aarhus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238680     History of Changes
Other Study ID Numbers: SHTIMER2005, 2005-41-4853, 20040192
Study First Received: October 12, 2005
Last Updated: June 13, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Overactive bladder
Children
Bladder rehabilitation

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on July 23, 2014