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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks). | |
| Nightly Timed Awakening | Experimental | Control-arm therapy plus a nightly timed-awakening intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of wet nights reported in electronic survey weekly for 12-weeks | All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period. | Baseline to 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the number of wet nights/week reported in electronic survey | All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period. | Baseline to 12-weeks |
| Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Do, DrPH | Contact | 3233612247 | cdo1@chla.usc.edu | |
| Jonathan Olais | Contact | 3233612247 | jolais@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evalynn Vasquez, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017770 | Lifting |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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|
All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention |
| 24-weeks post-intervention |
| Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm. | Intervention arm will report bed wetting via redcap electronic survey 1x/week for a 12-week period. | Baseline to 12-weeks |
| Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up. | All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention | Baseline to 24-week follow-up |
| Mean satisfaction score obtained from patient and parental satisfaction questionnaire. | Mean Patient and Parental Satisfaction Scores (Pq-EnU behavioral sub-score) will be collected via telehealth sessions. | Baseline to 12-weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |