A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis
| Registry | NCT06586476 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Children's Hospital Los Angeles (Other) |
| Conditions | Nocturnal Enuresis, Voiding Dysfunction |
| Interventions | Nightly Timed Awakening (Behavioral) |
| Dates | start 2024-10-01 (estimated), primary completion 2026-10-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-09-19, last updated 2024-09-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Nocturnal Enuresis All trials for Voiding Dysfunction All trials of Nightly Timed Awakening
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | No intervention | Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks). | |
| Nightly Timed Awakening | Experimental | Behavioral: Nightly Timed Awakening | Control-arm therapy plus a nightly timed-awakening intervention. |
Sex: All, ages: 6 Years to 17 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles, California | United States |