An interventional study of TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS in Bedwetting, sponsored by Heidi Stephany. Completed at 1 site in United States. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.
Sponsored by Heidi Stephany · Not applicable, Interventional, and Treatment
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
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.
845 studies on the registry are indexed under Enuresis; 81 are open to participants now.
This study's enrollment of 25 is below the median of 64 across 654 interventional studies indexed under Enuresis.
Browse Enuresis studies →Heidi Stephany is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit
Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS
electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Decrease in Nocturnal Enuresis
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
Quality of Life Questionnaire Scores
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.
Time frame: 6 weeks
| Milestone | Tibial Nerve Stimulation |
|---|---|
| Started | 25 |
| Completed | 22 |
| Not completed | 3 |
| Withdrew: Noncompliance by subjects | 3 |
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.
| Participants | Foot Stimulation |
|---|---|
| Decrease in Nocturnal Enuresis | 16 |
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.
| units on a scale | Foot Stimulation |
|---|---|
| Pre-stimulation | 13.9 (5 to 35) |
| Stimulation | 11.6 (5 to 33) |
| Post-stimulation | 10.5 (2 to 28) |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Foot Stimulation | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Tibial Nerve Stimulation |
|---|---|
| <=18 years | 22 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Tibial Nerve Stimulation |
|---|---|
| Mean | 11.4 (7 to 16) |
| Sex: Female, Male(Participants) | Tibial Nerve Stimulation |
|---|---|
| Female | 10 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | Tibial Nerve Stimulation |
|---|
| Region of Enrollment(Participants) | Tibial Nerve Stimulation |
|---|---|
| United States | 22 |
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