[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592993":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Shanghai Children's Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham Intervention Group","SHAM_COMPARATOR","This arm will enroll pediatric participants diagnosed with PNE, daytime urinary incontinence, or urinary frequency disorder according to the ICCS diagnostic criteria. Participants will follow the same baseline assessment protocol and stratified randomization based on sex, age, and enuresis frequency. They will undergo sham Micturition Desire-Relaxation Training, during which the device will remain inactive throughout each session. Training sessions will last approximately 10 minutes and be performed 5 to 10 times daily for a total of 4 weeks. A fluid intake and voiding diary will be submitted at the end of the sham training period. Participants will continue with follow-up assessments at 3 and 6 months post-intervention to evaluate natural symptom progression and recurrence, without further training.",[13],"Device: Sham device",{"label":15,"type":16,"description":17,"interventionNames":18},"Micturition Desire-Relaxation Training","EXPERIMENTAL","This study includes children diagnosed with PNE, daytime urinary incontinence, and urinary frequency disorder according to the ICCS diagnostic criteria. Participants in the intervention group will undergo Micturition Desire-Relaxation Training, with each session lasting approximately 10 minutes, performed 5 to 10 times per day over an 8-week period. Changes in clinical symptoms and any adverse events will be systematically documented at baseline, and at 1 and 2 months during the intervention, as well as at 3 and 6 months post-treatment. For participants who achieve complete remission, caregivers will be asked to maintain daily records of enuresis episodes at 3 and 6 months after treatment to monitor potential recurrence.",[19],"Device: Micturition Desire-Relaxation Training Device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Micturition Desire-Relaxation Training Device","The device was developed by Shanghai Children's Medical Center in collaboration with Shanghai University of Engineering Science. It plays relaxation videos through a VR device and monitors the subjects' brain waves in real time using electroencephalography to evaluate their relaxation levels. The relaxation material is adjusted accordingly, and urination is recorded after training. Urine is collected and analyzed with a flow meter, generating a diagnostic report.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham device","Participants diagnosed with nocturnal enuresis, daytime urinary incontinence, and urinary frequency will be screened at Shanghai Children's Medical Center, and eligible patients will be recruited. Participants will be randomly assigned to the sham training group, in which they will wear the device without powering it on for 10 minutes each session, 5-10 times a day, for 4 weeks.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"jun ma","CONTACT","13917230745","majun@shsmu.edu.cn",[38],{"facility":15,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Shanghai","Shanghai Municipality","200122","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"Jun Ma","15880030598",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100592993","micturition-desire-relaxation-training-device-for-lower-urinary-tract-dysfunction-in-children-100592993",false,"NCT07000656","Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children","Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study","ICCS，LUTD，PNE","Inclusion Criteria:\n\n1. Diagnosis according to the ICCS criteria:\n\n   For nocturnal enuresis:\n\n   At least one episode of involuntary nighttime urination per month for more than 3 months.\n\n   No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.\n\n   For daytime urinary incontinence:\n\n   At least one episode of intermittent urinary leakage during wakefulness per month for more than 3 months.\n\n   No anatomical or neurological causes of urinary incontinence.\n\n   For urinary frequency:\n\n   The child experiences only urinary frequency and urgency, occurring during the day and before sleep, with intervals ranging from a few minutes to 1 hour. Each urination involves a small volume, less than 50% of the estimated bladder capacity \\[EBC (mL) = 30 + (age × 30)\\], typically less than 30 mL, sometimes just a few drops, while total daily urine volume remains within normal limits. When the child is engaged in play or focused, the intervals between urination are extended, and urinary frequency symptoms disappear after falling asleep.\n2. Age: 5 to 18 years (inclusive), regardless of gender.\n3. Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Exclude enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injuries, epilepsy, cerebral developmental disorders, diabetes, and other neurological, urinary, or endocrine diseases, as well as transient enuresis due to excessive activity, mental fatigue, or excessive fluid intake before bedtime.\n2. Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.\n3. Patients who have participated in or are currently participating in other clinical trials within the past month.\n4. Patients deemed unsuitable for participation in the clinical trial by the investigator.","ALL","5 Years","18 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"NA","Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Relaxation, as a core physiological and psychological state, has been shown to promote effective urine storage and facilitate smooth voiding. By repeatedly training individuals to establish a new conditioned reflex linking the sensation of urinary urgency with a state of relaxation, it may be possible to improve bladder storage capacity and voiding function. Based on this concept, the investigators have developed the world's first Micturition Desire-Relaxation Training Device (Chinese Patent No.: ZL 2020 1 0397789.4). This study aims to evaluate the clinical efficacy of this device in treating LUTD in children.",[76,77,78,79],"Daytime Urinary Incontinence","Urinary Frequency","Lower Urinary Tract Dysfunction","Primary Nocturnal Enuresis","2025-06-02",{"date":82,"type":83},"2025-06-05","ACTUAL",{"date":85,"type":83},"2024-11-20",{"date":87,"type":70},"2026-05-31",{"name":5,"class":6},1]