NCT06586476尚未招募不适用
A Randomized Clinical Trial to Investigate the Efficacy and Feasibility of Timed Awakening in the Treatment of Enuresis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean number of wet nights reported in electronic survey weekly for 12-weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Mean number of wet nights reported in electronic survey weekly for 12-weeks
时间窗: Baseline to 12-weeks
All study participants will report bed wetting via redcap electronic survey 1x/week for a 12-week period.
次要结局
- Mean change from baseline in the number of wet nights/week reported in electronic survey(Baseline to 12-weeks)
- Percentage of patients with increased number of wet nights at 24-week follow-up as reported in electronic survey.(24-weeks post-intervention)
- Mean number of nights reported weekly in electronic survey with timed awakening for 12-week period for intervention arm.(Baseline to 12-weeks)
- Mean number of daytime accidents/week at baseline, end of 12-weeks and 24-weeks follow-up.(Baseline to 24-week follow-up)
- Mean satisfaction score obtained from patient and parental satisfaction questionnaire.(Baseline to 12-weeks)
研究者
Evalynn Vasquez
Medical Staff/USC Faculty CWR
Children's Hospital Los Angeles
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Scheduled Awakenings for the Treatment of Nocturnal EnuresisNocturnal EnuresisNCT03047720Indiana University20
进行中（未招募）
1 期
Good Nights Sleep Program to Improve Child and Family SleepSleep ProblemsSleep HygieneNCT06249217Auburn University60
Unknown
不适用
Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary SyndromeObstructive Sleep ApneaAcute Coronary SyndromeNCT02599298National University of Singapore193
已完成
不适用
Provigil (Modafinil) Study by Taiwan Biotech Co.NarcolepsyCataplexySleep DisordersHypersomnolenceExcessive SleepinessNCT00174174National Taiwan University Hospital30
已完成
不适用
Light Therapy for Depression During PregnancyPregnancyMajor Depressive DisorderNCT01043289Psychiatric Hospital of the University of Basel46