The Role of Timed Awakening in Treatment of Enuresis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nightly Timed Awakening.
- Who it may be relevant to
- Registry conditions: Nocturnal Enuresis, Voiding Dysfunction. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis
Overview
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
- Behavioral Nightly 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.
Primary outcome measures
- Mean number of wet nights reported in electronic survey weekly for 12-weeks [Time frame: Baseline to 12-weeks]
Secondary outcome measures (5)
- Mean change from baseline in the number of wet nights/week reported in electronic survey [Time frame: Baseline to 12-weeks]
- Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey. [Time frame: 24-weeks post-intervention]
- Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm. [Time frame: Baseline to 12-weeks]
- Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up. [Time frame: Baseline to 24-week follow-up]
- Mean satisfaction score obtained from patient and parental satisfaction questionnaire. [Time frame: Baseline to 12-weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT06586476 · CHLA-23-00080