Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Enuresis improvement rate — From enrollment to the end of treatment at 6 months
  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 — From enrollment to the end of treatment at 6 months
  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 — From enrollment to the end of treatment at 6 months
  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.

Trial sites (1)

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