Nocturnal Enuresis, Voiding Dysfunction
Conditions
Keywords
Lifting, Incontinence, Bedwetting
Brief summary
The goal of this clinical trial is to evaluate the effectiveness of nightly timed awakening in the treatment of nocturnal enuresis in children aged 6-17. The main questions it aims to: * Determine feasibility of nightly timed awakenings * Determine the role, if any, of comorbidities on resolution of enuresis * Determine incidence of daytime accidents * Obtain patient and parental satisfaction scores Researchers will compare a control group to treatment groups to see if there is any impact on nocturnal enuresis. Participants will be woken up by parents in the middle of the night to use the restroom. In addition, participants will receive 30 minute psychotherapy sessions using telehealth.
Interventions
BEHAVIORALNightly Timed Awakening
Patients in this arm will be awakened 1-hr after going to bed by their caregiver(s) to use the restroom and then returned to sleep. This awakening will occur every night.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Our inclusion criteria are new and recently evaluated (within past 6 months) patients who are English-speaking * aged 6-17 * referred to the urology clinic for enuresis (Enuresis in our study is defined as nocturnal or diurnal enuresis (more than 1 bedwetting episode/week) for greater than 3 months)
Exclusion criteria
* Diagnosis of enuresis with comorbid diagnosis of diabetes mellitus (type 1 and 2), diabetes insipidus, chronic kidney disease, polyuria and/or polydipsia * Structural urologic disease (evaluated via baseline imaging) * Diagnosis of neurodevelopmental delays or conditions (i.e. celebral palsy, autism spectrum disorder) that hinders inability to follow age-appropriate instructions * Not potty trained * Improved or resolved enuresis for patients recently evaluated (within the past 6 months) * Non-English speaking * Patients currently on any over-active-bladder (OAB) medications (b3- agonists, antichloingerics) or alpha blockers for urinary symptoms (i.e. alfuzosin, tamsulosion, etc) or anti-diurectic medications for urinary symptoms (i.e.: desmopression (DDAVP)) * Patients currently using bed-wetting alarms * Patients and families who are actively seeing Pediatric Clinical Urologic Psychologist. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent or participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of wet nights reported in electronic survey weekly for 12-weeks | Baseline to 12-weeks | All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in the number of wet nights/week reported in electronic survey | Baseline to 12-weeks | All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period. |
| Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey. | 24-weeks post-intervention | All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention |
| Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm. | Baseline to 12-weeks | Intervention arm will report bed wetting via redcap electronic survey 1x/week for a 12-week period. |
| Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up. | Baseline to 24-week follow-up | All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention |
| Mean satisfaction score obtained from patient and parental satisfaction questionnaire. | Baseline to 12-weeks | Mean Patient and Parental Satisfaction Scores (Pq-EnU behavioral sub-score) will be collected via telehealth sessions. |
Countries
United States
Contacts
Primary ContactChristine Do, DrPH
Backup ContactJonathan Olais
Outcome results
None listed