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.
Age: 5 to 18 years (inclusive), regardless of gender.
Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.
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.
Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
Patients who have participated in or are currently participating in other clinical trials within the past month.
Patients deemed unsuitable for participation in the clinical trial by the investigator.
Parallel
Micturition Desire-Relaxation Training Device
DeviceThe 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.
Sham device
DeviceParticipants 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.
Enuresis improvement rate
The enuresis improvement rate is the sum of the complete and partial response rates. No response: \<50% reduction. Partial response: 50 to 99% reduction. Complete response: 100% reduction.
Daytime urinary incontinence frequency
The frequency of daytime urinary incontinence will be recorded using a voiding diary, with caregivers documenting each episode of urine leakage during waking hours. The daily frequency will be categorized using a study-specific ordinal scoring system as follows: Score 0: No daytime incontinence Score 1: ≤1 episode/day Score 2: 2-3 episodes/day Score 3: ≥4 episodes/day Higher scores indicate more severe daytime urinary incontinence.
Total number of voiding episodes in 24 hours
The total number of voiding episodes per 24 hours will be calculated using a 3-day bladder diary. This includes both daytime and nighttime voids.
Grade scoring of the micturition desire - awakening function
The micturition desire-awakening function will be assessed using a study-specific, investigator-defined scoring system based on average nocturnal awakening ability. Scores range from 1 to 5, with higher scores indicating poorer awakening response to bladder signals. The scoring criteria are as follows: Score 5: Remains asleep most of the time after urination. Score 4: Only awakens after completely wetting the bed. Score 3: Awakens only after urinating a significant amount and then goes to the toilet to void the remaining urine. Score 2: Awakens after urinating a small amount and then goes to the toilet to void the remaining urine. Score 1: Awakened by the urge to urinate, without wetting the bed.
Enuresis recurrence rate
Recurrence is defined as the reappearance of enuresis in previously cured patients, occurring more than once per month.
Timing of nocturnal enuresis episodes
The timing of nocturnal enuresis episodes will be recorded during the night. If multiple episodes occur, the time of the first episode will be used for analysis.
Child's bedtime and wake time
The child's bedtime and wake-up time will be recorded daily throughout the intervention period.
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