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Completed

NCT Number: NCT02747849

Hand & Foot Nocturnal Enuresis TENS Study

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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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh og UPMC

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
  • Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
  • Having been assessed for and treated if applicable for constipation

Exclusion criteria

  • Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
  • Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
  • Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
  • Children who are not adequately potty trained
  • Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
  • Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
  • 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.

Treatment and study plan

TENS

Device

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.

Primary outcomes

  1. Change in Number of Nights Wet Per 2 Weeks

    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

  2. Response to Treatment

    Time frame: An average of 6 weeks

    Total number of participants that responded to treatment after stimulation with Hand or Foor unit.

Sponsors and collaborators

Lead sponsor

Rajeev Chaudhry

Other

Collaborators

  • The Coulter Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2016
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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