Bedtime Device Restriction and Desmopressin in PMNE.
21 augusti 2026 uppdaterad av: Abul-fotouh Ahmed, Al-Azhar University
Effect of Bedtime Digital-Device Restriction on the Therapeutic Response to Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Controlled Trial
This randomized controlled trial will evaluate whether restricting bedtime digital-device use improves the response to desmopressin in children with primary monosymptomatic nocturnal enuresis.
Participants will receive desmopressin for 8 weeks and will be assigned to either bedtime device restriction or usual screen habits.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
140
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Abul-fotouh Ahmed
- Telefonnummer: +201001066756
- E-post: abulfotouhahmed@yahoo.com
Studieorter
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-
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Cairo, Egypten
- Rekrytering
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
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Kontakt:
- Abul-fotouh Ahmed
- Telefonnummer: +201001066756
- E-post: abulfotouhahmed@yahoo.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Full Response Rate
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Wet Nights per Week
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 augusti 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
18 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UroAzhar_10_026
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