Foot Neuromodulation for Nocturnal Enuresis in Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bedwetting
- Sponsor
- Heidi Stephany
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Decrease in Nocturnal Enuresis
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Detailed Description
Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.
Investigators
Heidi Stephany
Assistant Professor
University of Pittsburgh
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.
Outcomes
Primary Outcomes
Decrease in Nocturnal Enuresis
Time Frame: 6 weeks
To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.
Secondary Outcomes
- Quality of Life Questionnaire Scores(6 weeks)