Hand & Foot Nocturnal Enuresis TENS Study



Status:Recruiting
Healthy:No
Age Range:5 - 18
Updated:10/17/2018
Start Date:April 2016
End Date:October 2019
Contact:Jennifer Clayton, BS
Email:jennifer.clayton2@chp.edu
Phone:4126927949

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Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children

The investigators believe in order to strengthen the evidence in support of transcutaneous
foot stimulation in this population the investigators need to move forward with a randomized
comparison study using the TENS device on the hand and foot as a control.

Nocturnal enuresis is a common problem in children which can have a dramatic psychological
and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of
peripheral tibial nerve branches has been shown to produce a prolonged inhibition of
micturition reflex contractions and significantly increase bladder capacity. The
investigators primary goal was to evaluate the effect of foot stimulation on the frequency of
nocturnal enuresis episodes in children.

Inclusion Criteria:

1. Children ages 5 to 18 years old without any specific neurological disorder or urinary
tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes
per month by history, nocturnal enuresis is a DSM V diagnosable medical condition

2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency,
urgency, or daytime incontinence

3. Having been assessed for and treated if applicable for behavioral etiologies of
nocturnal enuresis - consuming excess fluids or specific bladder irritants

4. Having been assessed for and treated if applicable for constipation

Exclusion Criteria:

1. Children with known neurological disorders which may be contributing to nocturnal
enuresis episodes

2. Children found through history to have significant behavioral causes of nocturnal
enuresis including consumption of excessive fluids or known bladder irritants

3. Children with chronic constipation who are non-compliant with previous pharmacologic
efforts to treat.

4. Children who are not adequately potty trained

5. Children with significant daytime symptoms of overactive bladder including frequency,
urgency, and daytime incontinence

6. Children who do not tolerate initial stimulation training session in the urology
clinic upon enrollment

7. Children with any implantable medical devices such as a pacemaker will be excluded
from the study

Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic
antidepressant for overactive bladder at time of enrollment will be eligible to participate
and will be continued on their usual medication and dosage throughout the study.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15224
Phone: 412-692-7932
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Pittsburgh, PA
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