Surface Nerve Stimulation Treatment for OAB in Children

Urinary Incontinence Clinical Trial

Official title:

Sacral Transcutaneous Nerve Stimulation Treatment for Functional Daytime Incontinence in Children With Over Active Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282490
• Other study ID #: SHTENS2006
• Secondary ID: 2006-41-6085,200
• Status: Completed
• Phase: N/A
• First received: January 25, 2006
• Last updated: June 13, 2008
• Start date: February 2006
• Est. completion date: March 2008

Study information

• Verified date: June 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.

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 of OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. In the non-responding cases behavioural modifying regimes can be coupled with anticholinergic medication. However, poor compliance of the child or parents, or dose limiting side effects often influences the efficacy of this intervention. Also a considerable number of children experience no or only limited effect from the treatment even though all instructions are complied with. This has let to research into new treatment modalities and the use of low frequency electrical current to inhibit detrusor overactivity in adults has become common. Pilot studies have indicated a significant effect of TENS on urinary incontinence in children with OAB.

Hypothesis:

• Sacral TENS is an effective treatment of urinary incontinence in children with OAB refractory to anticholinergic medication coupled with bladder training and voiding reeducation.

• The acute effect of sacral TENS can be identified by urodynamics

• It is possible to predict the outcome of sacral TENS treatment in these children.

30 children (age 5-14 years) with functional daytime incontinence refractory to anticholinergic medication coupled with bladder training. The study protocol consists of 1 week of basic home registrations and a 4 day in-patient phase succeeded by a 4 week home training period. The participants will be randomized to treatment with either active or inactive TENS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Daytime urinary incontinence with at least 1 episode of at least 1 ml per week

• Incontinence refractory to treatment

• Informed consent

Exclusion Criteria:

• Severe diseases of the kidneys or urinary tract besides OAB

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Device:
• Nerve stimulator

Locations

Country	Name	City	State
Denmark	Department of pediatrics,Skejby Sygehus, University hospital of Aarhus	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.
Secondary	Bladder capacity, voiding frequency and subjective impression of incontinence.