Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

Conditions
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Enuresis, Nocturnal Enuresis, Urinary Incontinence

Intervention / Treatment
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* Device: Transcutaneous Electric Nerve Stimulation (TENS) - active
* Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS, 10 weeks (active) 2 hours a day.<br>26 children. | Device: Transcutaneous Electric Nerve Stimulation (TENS) - active<br>* TENS is a non-invasive method using surface electrodes. Except a few cases with local skin irritation in the area where the electrodes are applied, there is no evidence of side effects of TENS treatment.<br>|
| Placebo Comparator: TENS, 10 weeks (placebo) 2 hours a day.<br>26 children. | Device: Transcutaneous Electric Nerve Stimulation (TENS) - placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of wet nights | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |