[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652577":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":55,"overallOfficials":66,"centralContacts":71,"locations":76,"responsibleParty":91,"collaborators":34,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":34,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":34,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":34,"overallStatus":79,"whyStopped":34,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Al-Azhar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Full Response Rate","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",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Change in Wet Nights per Week","Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.","Baseline to Week 8",{"measure":19,"description":20,"timeFrame":21},"Relapse Rate After Treatment","Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.","4 weeks after treatment discontinuation.",{"measure":23,"description":24,"timeFrame":25},"Adherence to Bedtime Device Restriction","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",{"measure":27,"description":28,"timeFrame":29},"Desmopressin Adherence","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.",{"measure":31,"description":32,"timeFrame":33},"Adverse Effects of Desmopressin","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",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","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.\n\nThe 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.\n\nThe 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.",[43,50],{"label":44,"type":45,"description":46,"interventionNames":47},"Desmopressin plus bedtime device restriction","EXPERIMENTAL","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.",[48,49],"Drug: Desmopressin","Behavioral: Bedtime digital-device restriction",{"label":51,"type":52,"description":53,"interventionNames":54},"Desmopressin only","ACTIVE_COMPARATOR","Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction.",[48],[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":34},"DRUG","Desmopressin","Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.",[51,44],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"BEHAVIORAL","Bedtime digital-device restriction","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.",[44],[67],{"name":68,"affiliation":69,"role":70},"Abul-fotouh Ahmed","Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt","PRINCIPAL_INVESTIGATOR",[72],{"name":68,"role":73,"phone":74,"phoneExt":34,"email":75},"CONTACT","+201001066756","abulfotouhahmed@yahoo.com",[77],{"facility":78,"status":79,"city":80,"state":34,"zip":34,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University","RECRUITING","Cairo","Egypt","EG",{"type":84,"coordinates":85},"Point",[86,87],31.24967,30.06263,{"lat":87,"lon":86},[90],{"name":68,"role":73,"phone":74,"phoneExt":34,"email":75},{"type":70,"investigatorFullName":68,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Principal Investigator","100652577","bedtime-device-restriction-and-desmopressin-in-pmne-100652577",false,"NCT07776977","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","Inclusion Criteria:\n\n* Age 6-14 years.\n* Diagnosis of PMNE (≥2 wet nights\u002Fweek for ≥6 months, no daytime symptoms, no prior sustained dryness \\>6 months).\n* Willingness to take oral desmopressin nightly for 8 weeks.\n* Parent\u002Fguardian able to monitor and report screen time and wet nights.\n* Written informed consent from parent\u002Fguardian and assent from child (if age-appropriate).\n\nExclusion Criteria:\n\n* Secondary enuresis or non-monosymptomatic enuresis (daytime incontinence, urgency, frequency).\n* Known organic causes (e.g., diabetes mellitus, urinary tract anomalies, neurological disorders).\n* Current use of other enuresis treatments (alarms, anticholinergics, imipramine) within 4 weeks prior to enrollment.\n* Severe sleep disorders (e.g., obstructive sleep apnea) or psychiatric conditions affecting compliance.\n* Inability to comply with study procedures or follow-up.","ALL","6 Years","14 Years",{"count":104,"type":105},140,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.",[111],"Primary Monosymptomatic Nocturnal Enuresis","2026-08-21",{"date":114,"type":115},"2026-08-24","ACTUAL",{"date":117,"type":115},"2026-08-20",{"date":119,"type":105},"2027-07",{"name":5,"class":6},1]