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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Abul-fotouh Ahmed
- 전화번호: +201001066756
- 이메일: abulfotouhahmed@yahoo.com
연구 장소
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Cairo, 이집트
- 모병
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
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연락하다:
- Abul-fotouh Ahmed
- 전화번호: +201001066756
- 이메일: abulfotouhahmed@yahoo.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: Desmopressin only
Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction.
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Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Full Response Rate
기간: Week 8, based on the final 2 weeks of treatment
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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.
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Week 8, based on the final 2 weeks of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Wet Nights per Week
기간: Baseline to Week 8
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Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.
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Baseline to Week 8
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Relapse Rate After Treatment
기간: 4 weeks after treatment discontinuation.
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Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.
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4 weeks after treatment discontinuation.
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Adherence to Bedtime Device Restriction
기간: During the 8-week treatment period
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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.
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During the 8-week treatment period
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Desmopressin Adherence
기간: During the 8-week treatment period.
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Proportion of prescribed desmopressin doses taken during the 8-week treatment period, based on parental report and pill count.
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During the 8-week treatment period.
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Adverse Effects of Desmopressin
기간: During the 8-week treatment period and 4 weeks after treatment discontinuation
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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.
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During the 8-week treatment period and 4 weeks after treatment discontinuation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UroAzhar_10_026
약물 및 장치 정보, 연구 문서
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