The Role of Timed Awakening in Treatment of Enuresis

Not Applicable

Not yet recruiting

• Conditions: Nocturnal Enuresis; Voiding Dysfunction
• Interventions: Behavioral: Nightly Timed Awakening

• Registration Number: NCT06586476
• Lead Sponsor: Children's Hospital Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nightly Timed Awakening	Nightly Timed Awakening	Control-arm therapy plus a nightly timed-awakening intervention.

Primary Outcome Measures

Name	Time	Method
Mean number of wet nights reported in electronic survey weekly for 12-weeks	Baseline to 12-weeks	All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in the number of wet nights/week reported in electronic survey	Baseline to 12-weeks	All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.	24-weeks post-intervention	All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention
Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.	Baseline to 12-weeks	Intervention arm will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.	Baseline to 24-week follow-up	All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention
Mean satisfaction score obtained from patient and parental satisfaction questionnaire.	Baseline to 12-weeks	Mean Patient and Parental Satisfaction Scores (Pq-EnU behavioral sub-score) will be collected via telehealth sessions.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States