Clinical trial NCT02600676: Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
Official title: Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enuresis
Nocturnal Enuresis
Urinary Incontinence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of wet nights
timeFrame: 1 year
Secondary outcomes:
measure: Maximum voided volume though daytime (MVV)
timeFrame: 1 year
measure: Nighttime urine production (NUP) on wet nights
timeFrame: 1 year
measure: Percent of wet night where NUP < MVV
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Søren Rittig, DMSc
role: PRINCIPAL_INVESTIGATOR
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