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 range

5 Years – 18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Bedwetting trials