Bedtime Device Restriction and Desmopressin in PMNE.
21. august 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Abul-fotouh Ahmed
- Telefonnummer: +201001066756
- E-post: abulfotouhahmed@yahoo.com
Studiesteder
-
-
-
Cairo, Egypt
- Rekruttering
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
-
Ta kontakt med:
- Abul-fotouh Ahmed
- Telefonnummer: +201001066756
- E-post: abulfotouhahmed@yahoo.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
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.
|
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Full Response Rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Wet Nights per Week
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. august 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
18. august 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UroAzhar_10_026
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .