The Role of Timed Awakening in Treatment of Enuresis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nightly Timed Awakening
BehavioralPatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Nightly Timed AwakeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean number of wet nights reported in electronic survey weekly for 12-weeks
All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
Time frame
Baseline to 12-weeksSecondary outcomes
1
Mean change from baseline in the number of wet nights/week reported in electronic survey
All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
Time frame
Baseline to 12-weeks2
Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.
All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention
Time frame
24-weeks post-intervention3
Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.
Intervention arm will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
Time frame
Baseline to 12-weeks4
Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.
All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention
Time frame
Baseline to 24-week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: