Children's Hospital of Pittsburgh og UPMC
Pittsburgh, Pennsylvania, 15224, United States
NCT Number: NCT02747849
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.
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Notify Me5 year–18 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
Time frame: 6 weeks
The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit
Time frame: An average of 6 weeks
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Rajeev Chaudhry
Other
Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children
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