Timed Awakening for Bedwetting

CD
JO
Overseen ByJonathan Olais
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether waking children at night to use the restroom (Nightly Timed Awakening) can reduce bedwetting. Researchers aim to determine the feasibility of this method and its impact on daytime accidents and satisfaction for both children and parents. The study compares a group receiving this treatment to a group receiving regular care to evaluate effectiveness. Children aged 6-17 who have been bedwetting at least once a week for over three months and have recently been evaluated by a urologist may be suitable candidates. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance bedwetting management.

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 prior data suggests that this method is safe for children?

Research has shown that waking a child at night to prevent bedwetting, also known as nocturnal enuresis, is generally safe. Studies have found no safety concerns with this method, which involves gently waking the child to use the bathroom. This approach is simple and non-invasive.

Similarly, alarm therapy, another method to prevent bedwetting, is widely used and has not been linked to any side effects. These methods are considered safe and can effectively help manage bedwetting in children. Parents can feel reassured about the safety of these approaches.12345

Why are researchers excited about this trial?

Researchers are excited about the nightly timed awakening technique for bedwetting because it introduces a proactive, structured approach to managing the condition. Unlike standard treatments, which typically involve urotherapy and psychotherapy, this method focuses on training the body to wake up at specific times, potentially helping to regulate bladder control naturally. This technique could empower individuals to anticipate and respond to their body's signals, offering a non-invasive and behavior-focused alternative to traditional care methods.

What evidence suggests that nightly timed awakening is effective for bedwetting?

Research has shown that waking children at night to use the bathroom can help manage bedwetting. In this trial, participants in the experimental arm will receive a nightly timed-awakening intervention. Studies have found that scheduled awakenings can reduce bedwetting incidents. In a large study on various behavioral treatments, including this method, about 18% of children improved. Although this success rate might seem small, it can be useful when combined with other treatments. Overall, waking children at night offers a potential benefit for those dealing with bedwetting.12678

Who Is on the Research Team?

EV

Evalynn Vasquez, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Nightly Timed AwakeningExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

Citations

Scheduled Awakenings for the Treatment of Nocturnal ...The aim of this study is to determine the effectiveness of scheduled awakenings, with the Lully Sleep Guardian, in patients with PMNE, at reducing the frequency ...
Timed Awakening for Bedwetting · Info for ParticipantsThe 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 ...
A pediatric urologist outlines gaps and opportunities in ...But if you look at the largest published study on behavioral therapy and its ability to correct bedwetting, the success is approximately 18%, so ...
Sleep Monitoring of Children With Nocturnal EnuresisThe purpose of this article is to provide a succinct summary of the sleep monitoring efforts that have been used in nocturnal enuresis (NE)
Improving the efficacy of enuresis alarm treatment through ...The enuresis alarm treatment has a reported success rate above 50% but requires significant effort from the families involved. Additionally, ...
Alarm interventions for nocturnal enuresis in children - PMCAlthough enuresis in itself is pathologically benign and has a high rate of spontaneous remission, it can affect children's quality of life and self‐esteem, as ...
Overview on the management of nocturnal enuresis in ...Alarm therapy remains a cornerstone in contemporary practice, boasting a high response rate ranging between 50 % and 70 % with no reported side effects.
Scheduled Awakenings for the Treatment of Nocturnal EnuresisThis study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
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