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NCT Number: NCT06586476

The Role of Timed Awakening in Treatment of Enuresis

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.

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Key information

Conditions

Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases Voiding Dysfunction

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

Christine Do, DrPH

CONTACT

[email protected]

Jonathan Olais, MPA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nightly Timed Awakening

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.

Other names: Lifting

Primary outcomes

  1. 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

  1. Mean change from baseline in the number of wet nights/week reported in electronic survey

    Time frame: Baseline to 12-weeks

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

  2. Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.

    Time frame: 24-weeks post-intervention

    All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention

  3. Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.

    Time frame: Baseline to 12-weeks

    Intervention arm will report bed wetting via redcap electronic survey 1x/week for a 12-week period.

  4. Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.

    Time frame: Baseline to 24-week follow-up

    All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention

  5. Mean satisfaction score obtained from patient and parental satisfaction questionnaire.

    Time frame: Baseline to 12-weeks

    Mean Patient and Parental Satisfaction Scores (Pq-EnU behavioral sub-score) will be collected via telehealth sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Do, DrPH

CONTACT

[email protected]

3233612247

Jonathan Olais

CONTACT

[email protected]

3233612247

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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