The Role of Timed Awakening in Treatment of Enuresis

Официальное название

A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis

Обзор

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.

Вмешательства

• Поведенческое Nightly Timed Awakening
  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.

Первичные конечные точки

• Mean number of wet nights reported in electronic survey weekly for 12-weeks [Срок оценки: Baseline to 12-weeks]

Вторичные конечные точки (5)

• Mean change from baseline in the number of wet nights/week reported in electronic survey [Срок оценки: Baseline to 12-weeks]
• Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey. [Срок оценки: 24-weeks post-intervention]
• Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm. [Срок оценки: Baseline to 12-weeks]
• Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up. [Срок оценки: Baseline to 24-week follow-up]
• Mean satisfaction score obtained from patient and parental satisfaction questionnaire. [Срок оценки: Baseline to 12-weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06586476 · CHLA-23-00080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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