Bedtime Device Restriction and Desmopressin in PMNE.
Effect of Bedtime Digital-Device Restriction on the Therapeutic Response to Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Controlled Trial
研究概览
详细说明
This is a prospective, parallel-group, open-label randomized controlled trial conducted at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt. Children aged 6-14 years with primary monosymptomatic nocturnal enuresis will be enrolled and randomized 1:1 to receive desmopressin plus bedtime digital-device restriction or desmopressin with no restriction.
The intervention group will avoid digital devices, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. The control group will continue the usual screen habits. All participants will receive oral desmopressin at bedtime for 8 weeks, with dose adjustment allowed according to clinical response.
The primary outcome is the proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of treatment. Secondary outcomes include reduction in wet nights per week, partial response rate, sleep quality, adherence, and relapse 4 weeks after treatment discontinuation. Baseline demographic, clinical, and sleep-related data will also be collected to explore predictors of treatment response.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Abul-fotouh Ahmed
- 电话号码：+201001066756
- 邮箱：abulfotouhahmed@yahoo.com
学习地点
-
-
-
Cairo、埃及
- 招聘中
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
-
接触：
- Abul-fotouh Ahmed
- 电话号码：+201001066756
- 邮箱：abulfotouhahmed@yahoo.com
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Age 6-14 years.
- Diagnosis of PMNE (≥2 wet nights/week for ≥6 months, no daytime symptoms, no prior sustained dryness >6 months).
- Willingness to take oral desmopressin nightly for 8 weeks.
- Parent/guardian able to monitor and report screen time and wet nights.
- Written informed consent from parent/guardian and assent from child (if age-appropriate).
Exclusion Criteria:
- Secondary enuresis or non-monosymptomatic enuresis (daytime incontinence, urgency, frequency).
- Known organic causes (e.g., diabetes mellitus, urinary tract anomalies, neurological disorders).
- Current use of other enuresis treatments (alarms, anticholinergics, imipramine) within 4 weeks prior to enrollment.
- Severe sleep disorders (e.g., obstructive sleep apnea) or psychiatric conditions affecting compliance.
- Inability to comply with study procedures or follow-up.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Desmopressin plus bedtime device restriction
Participants will receive oral desmopressin at bedtime for 8 weeks and will avoid digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime.
|
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
Restriction of digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime during the 8-week treatment period.
|
|
有源比较器：Desmopressin only
Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction.
|
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Full Response Rate
大体时间：Week 8, based on the final 2 weeks of treatment
|
Proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of the 8-week treatment period.
|
Week 8, based on the final 2 weeks of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Wet Nights per Week
大体时间：Baseline to Week 8
|
Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.
|
Baseline to Week 8
|
|
Relapse Rate After Treatment
大体时间：4 weeks after treatment discontinuation.
|
Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.
|
4 weeks after treatment discontinuation.
|
|
Adherence to Bedtime Device Restriction
大体时间：During the 8-week treatment period
|
Proportion of nights in which participants in the intervention group avoided digital-device use for at least 60 minutes before bedtime, based on parental log.
|
During the 8-week treatment period
|
|
Desmopressin Adherence
大体时间：During the 8-week treatment period.
|
Proportion of prescribed desmopressin doses taken during the 8-week treatment period, based on parental report and pill count.
|
During the 8-week treatment period.
|
|
Adverse Effects of Desmopressin
大体时间：During the 8-week treatment period and 4 weeks after treatment discontinuation
|
Proportion of participants experiencing adverse effects related to desmopressin, including headache, nausea, vomiting, hyponatremia symptoms, excessive thirst, fluid retention, or any other treatment-emergent adverse event.
|
During the 8-week treatment period and 4 weeks after treatment discontinuation
|
合作者和调查者
调查人员
- 首席研究员：Abul-fotouh Ahmed、Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.