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Behavioral Intervention
Timed Awakening for Bedwetting
N/A
Waitlist Available
Led By Evalynn Vasquez, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Referred to the urology clinic for enuresis (Enuresis defined as nocturnal or diurnal enuresis for greater than 3 months)
Be younger than 18 years old
Must not have
Currently on over-active-bladder (OAB) medications, alpha blockers, or anti-diuretic medications for urinary symptoms
Diagnosis of enuresis with comorbid diagnosis of diabetes mellitus, diabetes insipidus, chronic kidney disease, polyuria, or polydipsia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-weeks post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if waking children up at night to use the restroom can help with bedwetting. They will also look at how other health conditions may affect the results, the number of accidents
Who is the study for?
This trial is for children aged 6-17 who experience bedwetting. They should be able to participate in nightly awakenings and telehealth psychotherapy sessions. There are no specific exclusion criteria provided, but typically those with other medical conditions affecting sleep or bladder control might not qualify.
What is being tested?
The study tests if waking kids up at night to use the bathroom can help stop bedwetting. It compares a group that follows this routine against one that doesn't, checking for any improvements in nighttime dryness and daytime accidents, as well as satisfaction from both kids and parents.
What are the potential side effects?
There may not be direct 'side effects' like with medications, but possible issues include sleep disruption for the child and family, potential resistance or emotional distress from being woken up regularly, and possibly increased daytime tiredness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing bedwetting for more than 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for overactive bladder or urinary symptoms.
Select...
I have bed-wetting issues and also suffer from diabetes or kidney problems.
Select...
My scans show a structural issue with my urinary system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-weeks post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean number of wet nights reported in electronic survey weekly for 12-weeks
Secondary study objectives
Mean change from baseline in the number of wet nights/week reported in electronic survey
Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.
Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nightly Timed AwakeningExperimental Treatment1 Intervention
Control-arm therapy plus a nightly timed-awakening intervention.
Group II: ControlActive Control1 Intervention
Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks).
Find a Location
Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
249 Previous Clinical Trials
5,074,634 Total Patients Enrolled
Evalynn Vasquez, MDPrincipal InvestigatorChildren's Hospital Los Angeles