Urinary Incontinence Clinical Trial
Official title:
Randomized, Double Blind, Placebo Controlled Trial of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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