N/A
N=25
Foot Neuromodulation for Nocturnal Enuresis
Bedwetting
Bottom Line
View on ClinicalTrials.gov: NCT02315560 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Decrease in Nocturnal Enuresis — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Heidi Stephany
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in Nocturnal Enuresis |
16 | — |
| SECONDARY Quality of Life Questionnaire Scores |
13.9; 11.6; 10.5 | — |
Summary
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Eligibility Criteria
Inclusion Criteria
- Children ages 5 to 16 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
- 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.
Data sourced from ClinicalTrials.gov (NCT02315560). 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.