N/A N=27 Randomized Treatment

Hand & Foot Nocturnal Enuresis TENS Study

Bedwetting

Bottom Line

View on ClinicalTrials.gov: NCT02747849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Change in Number of Nights Wet Per 2 Weeks — 11; 8.78; 8.75; 6.22 # nights wet over 2 weeks

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TENS (Device)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: Rajeev Chaudhry
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Number of Nights Wet Per 2 Weeks	11; 8.78; 8.75; 6.22; 9.5; 6.78	—
PRIMARY Response to Treatment	8; 9	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02747849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.