Timed Awakening for Bedwetting

Overseen By Jonathan Olais

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must not be taking: OAB medications, Alpha blockers

Disqualifiers: Diabetes, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking medications for overactive bladder, alpha blockers, or anti-diuretic medications for urinary symptoms, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Nightly Timed Awakening for bedwetting?

Research suggests that simple behavioral methods like waking children at night to urinate can help manage bedwetting. This approach is similar to the Nightly Timed Awakening treatment, indicating it may be effective. ^{1 2 3 4 5}

Is Timed Awakening for Bedwetting safe for humans?

The research articles reviewed do not provide specific safety data for Timed Awakening for Bedwetting, but alarm therapy, a similar treatment, is commonly recommended and considered safe for children with bedwetting issues. ^{3 6 7 8 9}

How does the Timed Awakening treatment for bedwetting differ from other treatments?

Timed Awakening for bedwetting is unique because it involves waking the child at specific times during the night to use the bathroom, which is different from other treatments like alarm therapy that rely on a device to wake the child when wetting occurs. This method directly addresses the timing of bladder activity and aims to train the child's body to wake up before wetting happens. ^{1 6 7 10 11}

Research Team

Evalynn Vasquez, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

I have been experiencing bedwetting for more than 3 months.

Exclusion Criteria

Actively seeing Pediatric Clinical Urologic Psychologist

I have bed-wetting issues and also suffer from diabetes or kidney problems.

Diagnosis of neurodevelopmental delays or conditions that hinder ability to follow age-appropriate instructions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nightly timed awakenings and 30-minute psychotherapy sessions using telehealth

12 weeks

Weekly telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Electronic survey follow-up

Treatment Details

Interventions

• Nightly Timed Awakening

Trial Overview 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.

Participant Groups

Group I: Nightly Timed Awakening Experimental Treatment 1 Intervention

Control-arm therapy plus a nightly timed-awakening intervention.

Group II: Control Active Control 1 Intervention

Standard of care, which includes in-clinic urotherapy at evaluation and 30-minutes psychotherapy sessions (every 3 weeks).

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Apparative therapy of enuresis nocturna, experience and problems]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Urotherapy recommendations for bedwetting. [2018]

3. Brazil pubmed.ncbi.nlm.nih.gov

Behavioral alarm treatment for nocturnal enuresis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Daytime bladder dysfunction in therapy-resistant nocturnal enuresis. A pilot study in urotherapy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Simple behavioural and physical interventions for nocturnal enuresis in children. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Bed-wetting in US children: epidemiology and related behavior problems. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Alarm treatment is successful in children with day- and night-time wetting. [2006]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Medical management of nocturnal enuresis. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

4. Bedwetting and toileting problems in children. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Enuretic children have a higher variability in REM sleep when comparing their sleep parameters with nonenuretic control children using a wearable sleep tracker at home. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

[Dry bed training in nocturnal enuresis]. [2014]