Nocturnal EnuresisNCT06586476
The Role of Timed Awakening in Treatment of Enuresis
A study testing Nightly Timed Awakening in people with Nocturnal Enuresis and Voiding Dysfunction, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Nocturnal Enuresis, Voiding Dysfunction
- What is being tested?
- Nightly Timed Awakening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
Christine Do, DrPH, cdo1@chla.usc.edu
Jonathan Olais, MPA, jolais@chla.usc.edu
About this study
Official title: A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the 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.
- Conditions
- Nocturnal Enuresis, Voiding Dysfunction
- Being tested
- Nightly Timed Awakening
- Keywords
- Lifting, Incontinence, Bedwetting
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nightly Timed AwakeningBehavioural
Also called Lifting
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nightly Timed Awakening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12-weeks
Secondary outcomes (5)
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.
Measured: Baseline to 12-weeks
Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.
All study participants will report bed wetting via redcap electronic survey 24-week after completion of intervention
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evalynn Vasquez, Children's Hospital Los Angeles
- Investigators
- Evalynn Vasquez, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586476
- Sponsor's protocol ID
- CHLA-23-00080
- Status last verified
- Apr 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis
- ClinicalTrials.gov ID
- NCT06586476
- Acronym / sponsor ID
- CHLA-23-00080
- Conditions
- Nocturnal Enuresis, Voiding Dysfunction
- Keywords
- Lifting, Incontinence, Bedwetting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Nightly Timed AwakeningControl-arm therapy plus a nightly timed-awakening intervention. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nightly Timed AwakeningAlso: LiftingPatients 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. | Behavioural | Nightly Timed Awakening |
Primary outcome
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.
5 secondary outcomes
Mean change from baseline in the number of wet nights/week reported in electronic survey
Time frame: Baseline to 12-weeks
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
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
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
Mean satisfaction score obtained from patient and parental satisfaction questionnaire.
Time frame: Baseline to 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evalynn Vasquez, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nightly Timed Awakening in people with Nocturnal Enuresis and Voiding Dysfunction, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Do, DrPH (3233612247, cdo1@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of wet nights reported in electronic survey weekly for 12-weeks (time frame: Baseline to 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.