[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584016":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":35,"locations":45,"responsibleParty":77,"collaborators":80,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":12,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":12,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":48,"whyStopped":12,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Bahçeşehir University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group (CG)","NO_INTERVENTION","The group that will receive first-line treatment, consisting of classic DDVAP treatment with evidence level A and urotherapy training, will be included in the treatment of PMNE. The DDVAP dosage will be determined and prescribed by the pediatric urologist. Only these treatments will be applied, and no pelvic floor rehabilitation will be implemented.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Structered Pelvic Floor Muscle Rehabilitation Group (SPFMRG)","EXPERIMENTAL","This group will receive, in addition to the DDVAP therapy prescribed by the pediatric urologist and urotherapy training, 10 weeks of structured pelvic floor muscle rehabilitation sessions.",[18],"Other: Structured pelvic floor rehabilitation",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Structured pelvic floor rehabilitation","The classic DDVAP therapy will be administered by the pediatric urologist. The classic urotherapy training recommended for enuresis will be provided by the physiotherapist. In addition, structured pelvic floor muscle rehabilitation (SPFMR) will be provided by the physiotherapist for 10 weeks. Each session is planned to last approximately 60 minutes.\n\nSPFMR will include multiple interventions combined. Below is information about the brief interventions.\n\n* Diaphragmatic Breathing Training\n* Pelvic Floor Training with Biofeedback\n* Core Stabilization Exercises\n* Squat Exercises\n* External Rotator Strengthing\n* Adductor Strengthing\n* Balance Training\n* Home Exercises",[14],[25,28,32],{"name":26,"affiliation":5,"role":27},"Pelin Pisirici, Assist. Prof.","STUDY_DIRECTOR",{"name":29,"affiliation":30,"role":31},"Mesrur Selcuk Silay, Prof. Dr.","Medipol University","STUDY_CHAIR",{"name":33,"affiliation":5,"role":34},"Aygul Koseoglu Kurt, Ph.D. (c)","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":12,"email":40},"Aygul Koseoglu Kurt, Ph.D. (c), PT","CONTACT","+90 544 477 0157","aygulkoseoglu@gmail.com",{"name":26,"role":38,"phone":42,"phoneExt":43,"email":44},"+90 212 381 9198","9198","pelin.pisirici@hes.bau.edu.tr",[46,67],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":12,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Private Selcuk Silay Pediatric Urology Clinic","RECRUITING","Istanbul","Beşiktaş","34349","Turkey (Türkiye)",{"type":54,"coordinates":55},"Point",[56,57],28.94966,41.01384,{"lat":57,"lon":56},[60,63,64,66],{"name":29,"role":38,"phone":61,"phoneExt":12,"email":62},"+90 505 645 4005","selcuksilay@gmail.com",{"name":33,"role":34,"phone":12,"phoneExt":12,"email":12},{"name":26,"role":65,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"name":29,"role":65,"phone":12,"phoneExt":12,"email":12},{"facility":68,"status":69,"city":49,"state":70,"zip":71,"country":52,"countryCode":12,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Medipol Acıbadem Region Hospital","NOT_YET_RECRUITING","Kadıkoy","34718",{"type":54,"coordinates":73},[56,57],{"lat":57,"lon":56},[76],{"name":29,"role":38,"phone":61,"phoneExt":12,"email":62},{"type":34,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Aygul Koseoglu Kurt","Principal investigator",[81,84],{"name":82,"class":83},"Private Selcuk Sılay Pediatric Urology Clinic","UNKNOWN",{"name":85,"class":83},"Medipol Acıbadem Regional Hospital","100584016","effectiveness-of-pelvic-floor-muscle-rehabilitation-combined-with-desmopressin-in-children-with-primary-monosymptomatic-nocturnal-enuresis-100584016",false,"NCT06883851","Effectiveness of Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis","Evaluating the Efficacy of Structured Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in the Management of Primary Monosymptomatic Nocturnal Enuresis in Children","Inclusion Criteria:\n\n* Being between 7 and 13 years old\n* Diagnosed with primary MNE by a pediatric urology department within the last 6 months\n* No urinary tract infection verified by laboratory tests\n* Ability to communicate in Turkish and absence of mental deficit\n* No diagnosed psychiatric problems\n* Willingness to participate in the study (child and family)\n\nExclusion Criteria:\n\n* Presence of orthopedic conditions preventing evaluation\n* Anatomical anomalies in the urinary system\n* History of urinary system surgery\n* Neurological disorders\n* Presence of mental retardation\n* History of orthopedic surgery that could alter pelvic or lower extremity integrity\n* Receiving PFM rehabilitation in the last 6 months\n* Using nighttime alarm therapy in the last 6 months\n* Receiving any treatment for enuresis in the last 6 months","ALL","7 Years","13 Years",{"count":97,"type":98},40,"ESTIMATED","INTERVENTIONAL",[101],"NA","The aim of this randomized controlled trial is to evaluate the effects of Structured Pelvic Floor Muscle Rehabilitation (SPFMR) in children with Primary Monosymptomatic Nocturnal Enuresis (PMNE) who are undergoing desmopressin asetat (DDAVP) treatment prescribed by a pediatric urologist. The study aims to investigate whether SPFMR can reduce the frequency and severity of enuresis episodes and whether it can also reduce relapse rates in the short- and long-term follow-up. The main questions the study seeks to answer are:\n\n* Does SPFMR reduce the frequency and severity of enuresis episodes in children with PMNE?\n* Does SPFMR treatment reduce relapse rates in children with PMNE in the long term? Researchers will compare the group receiving SPFMR in addition to DDAVP treatment with a control group receiving only DDAVP treatment. This comparison will help evaluate the effect of SPFMR on the severity of enuresis episodes and relapse rates.\n\nParticipants will:\n\n* Receive DDAVP treatment (SPFMR group and Control group)\n* Participate in SPFMR sessions ( SPFMR group)\n* Keep a diary of enuresis frequency and severity\n* Assess relapse during short- and long-term follow-up\n\nThe hypotheses of the study are:\n\nH0: Adding SPFMR to desmopressin treatment for children with PMNE has no short-term effect on the severity of enuresis episodes.\n\nH1: Adding SPFMR to desmopressin treatment for children with PMNE has a short-term effect on the severity of enuresis episodes.\n\nH0: Adding SPFMR to desmopressin treatment for children with PMNE has no long-term effect on the severity of enuresis episodes.\n\nH2: Adding SPFMR to desmopressin treatment for children with PMNE has a long-term effect on the severity of enuresis episodes.",[104,105],"Primary Nocturnal Enuresis","Nocturnal Enuresis in Children",[107,108,109,110,111,112,113,114,115],"biofeedback","core stabilization","exercise","urinary incontinence","management","treatment","enuresis","pelvic floor rehabilitation","desmopressin","2025-03-16",{"date":118,"type":119},"2025-03-19","ACTUAL",{"date":121,"type":119},"2025-03-11",{"date":123,"type":98},"2027-08-30",{"name":5,"class":6},2]