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The Role of Timed Awakening in Treatment of Enuresis

Children's Hospital Los Angeles logo

Children's Hospital Los Angeles

Status

Not yet enrolling

Conditions

Nocturnal Enuresis
Voiding Dysfunction

Treatments

Behavioral: Nightly Timed Awakening

Study type

Interventional

Funder types

Other

Identifiers

NCT06586476
CHLA-23-00080

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Control
No Intervention group
Description:
Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks).
Nightly Timed Awakening
Experimental group
Description:
Control-arm therapy plus a nightly timed-awakening intervention.
Treatment:
Behavioral: Nightly Timed Awakening

Trial contacts and locations

1

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Central trial contact

Jonathan Olais; Christine Do, DrPH

Data sourced from clinicaltrials.gov

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