CompletedNot Applicable

Hand & Foot Nocturnal Enuresis TENS Study

United States27 participantsStarted 2016-04

Plain-language summary

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.

Who can participate

Age range5 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Number of Nights Wet Per 2 Weeks

Timeframe: 6 weeks

Response to Treatment

Timeframe: An average of 6 weeks

Trial details

NCT IDNCT02747849

SponsorRajeev Chaudhry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Results submitted2022-12-22

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