Clinical trial NCT06586476: The Role of Timed Awakening in Treatment of Enuresis
Official title: A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nocturnal Enuresis
Voiding Dysfunction
Keywords: Lifting
Incontinence
Bedwetting
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean number of wet nights reported in electronic survey weekly for 12-weeks
timeFrame: Baseline to 12-weeks
Secondary outcomes:
measure: Mean change from baseline in the number of wet nights/week reported in electronic survey
timeFrame: Baseline to 12-weeks
measure: Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.
timeFrame: 24-weeks post-intervention
measure: Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.
timeFrame: Baseline to 12-weeks
measure: Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.
timeFrame: Baseline to 24-week follow-up
measure: Mean satisfaction score obtained from patient and parental satisfaction questionnaire.
timeFrame: Baseline to 12-weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Evalynn Vasquez, MD
role: PRINCIPAL_INVESTIGATOR
References: