A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis

Children's Hospital Los Angeles1 site in 1 country40 target enrollmentOctober 1, 2024

ConditionsNocturnal Enuresis Voiding Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nocturnal Enuresis
Sponsor: Children's Hospital Los Angeles
Enrollment: 40
Locations: 1
Primary Endpoint: Mean number of wet nights reported in electronic survey weekly for 12-weeks
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2024

End Date

December 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Children's Hospital Los Angeles

Responsible Party

Principal Investigator

Evalynn Vasquez

Medical Staff/USC Faculty CWR

Children's Hospital Los Angeles

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

Outcomes

Primary Outcomes

Mean number of wet nights reported in electronic survey weekly for 12-weeks

Time Frame: Baseline to 12-weeks

All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.

Secondary Outcomes

Mean change from baseline in the number of wet nights/week reported in electronic survey(Baseline to 12-weeks)
Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.(24-weeks post-intervention)
Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.(Baseline to 12-weeks)
Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.(Baseline to 24-week follow-up)
Mean satisfaction score obtained from patient and parental satisfaction questionnaire.(Baseline to 12-weeks)