Surface Nerve Stimulation Treatment for OAB in Children
Condition: Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Nerve stimulator
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive bladder; Children; Nerve stimulation; TENS