Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

Not Applicable

Completed

Interventions: Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo
Device: Transcutaneous Electric Nerve Stimulation (TENS) - active

Brief Summary: This is a randomized, double blind, placebo controlled study of the effect of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic nocturnal enuresis (MNE).

Detailed Description: Objectives:

Nighttime urinary incontinence (enuresis) is seen by 5-10% of children from six to fifteen years. Enuresis is a socially and psychologically stressful condition that can lead to bullying and low self esteem. Today the condition is treated with desmopressin or bells, that awake children at nighttime urination. One third of children suffering from enuresis are refractory to first line of treatment. Transcutaneous Electric Nerve Stimulation (TENS) has been documented efficacious on symptoms in children with daytime incontinence. Little is known regarding the effect of TENS on monosymptomatic nocturnal enuresis (MNE). The aim of our study is to investigate the effect of TENS on children diagnosed with MNE.

Methods:

This is a randomized, double blind, placebo controlled study of the effect of TENS in fifty-two children with MNE. The study period is from September 2015 to September 2016. The children recruited will receive TENS one hour during daytime and one hour during sleep for a total treatment period of ten weeks. The surface electrodes will be placed on the skin over s2-s3. TENS is safe and not associated with adverse effects.

Expected results:

The investigators hypothesize a reduction in number of wet nights in the enuretic children receiving active TENS. If TENS proves effective in children with enuresis it will be implemented as part of enuresis treatment in the clinical practice.

Recruitment & Eligibility

Inclusion Criteria

Unremarkable clinical examination
3 or more wet nights per week
No treatment of enuresis 1 week before the treatment starts (for bells two weeks)

Exclusion Criteria

Nighttime urine production on wet nights > 130 % of "maximum voided volume" (MVV) for age
Ongoing constipation and/or faecal incontinence that are not successfully treated
Daytime incontinence
Prior or ongoing treatment with TENS
Current or previous clinical history, clinical or laboratory findings or daily treatment with drugs that can be related to diseases or conditions that are expected to change the parameters investigated, especially diseases of the kidney and urinary tract or endocrine disorder
Neurological and/or significant anatomical abnormalities of the urinary tract
Previous operation in the urinary tract
Recurrent urinary tract infections
Incomplete bladder emptying (assessed with ultrasound) which means post micturition urine volume in the bladder > 20 ml or > 10 % of the total urine production

Arm && Interventions

Group	Intervention	Description
TENS, 10 weeks (placebo) 2 hours a day.	Transcutaneous Electric Nerve Stimulation (TENS) - placebo	26 children.
TENS, 10 weeks (active) 2 hours a day.	Transcutaneous Electric Nerve Stimulation (TENS) - active	26 children.

Primary Outcome Measures

Name	Time	Method
Frequency of wet nights	1 year	Non-response is a reduction in wet nights \< 50%, partial response a reduction of 50-89%, response a reduction of 90-99% and full response a reduction of 100% or less than one wet night in a month

Secondary Outcome Measures

Name	Time	Method
Maximum voided volume though daytime (MVV)	1 year
Nighttime urine production (NUP) on wet nights	1 year
Percent of wet night where NUP < MVV	1 year

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