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Clinical Trials/NCT06586476
NCT06586476Not yet recruitingNot Applicable

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

Children's Hospital Los Angeles2 sites in 1 country40 target enrollmentStarted: October 1, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
2
Primary Endpoint
Mean number of wet nights reported in electronic survey weekly for 12-weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Evalynn Vasquez

Medical Staff/USC Faculty CWR

Children's Hospital Los Angeles

Study Sites (2)

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