Children's Hospital of Pittsburgh og UPMC
Pittsburgh, Pennsylvania, 15224, United States
NCT Number: NCT02315560
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
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Notify Me5 year–16 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
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.
Time frame: 6 weeks
The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.
Heidi Stephany
Other
Foot Neuromodulation for Nocturnal Enuresis in Children
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