The Role of Timed Awakening in Treatment of Enuresis

NCT ID: NCT06586476

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-01

Brief Summary

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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

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Conditions

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Nocturnal Enuresis Voiding Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks).

Group Type NO_INTERVENTION

No interventions assigned to this group

Nightly Timed Awakening

Control-arm therapy plus a nightly timed-awakening intervention.

Group Type EXPERIMENTAL

Nightly Timed Awakening

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifting

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Evalynn Vasquez

Medical Staff/USC Faculty CWR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evalynn Vasquez, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Christine Do, DrPH

Role: CONTACT

3233612247

Jonathan Olais

Role: CONTACT

3233612247

Facility Contacts

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Christine Do, DrPH

Role: primary

Jonathan Olais, MPA

Role: backup

Other Identifiers

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CHLA-23-00080

Identifier Type: -

Identifier Source: org_study_id

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