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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial aims to evaluate the clinical efficacy of the Micturition Desire-Relaxation Training Device in managing LUTD in children over a six-month period. A stratified block randomization method will be used, matching participants based on sex, age, and enuresis frequency. Eligible participants will be stratified by sex and age, and then randomly assigned (1:1) to either the intervention group or the sham intervention group using a computer-generated sequence. This method ensures group balance regarding baseline characteristics and enuresis severity. In the intervention group, baseline voiding diaries will be completed prior to initiating training. The first session will be supervised by trained medical personnel, during which participants and caregivers will receive standardized instruction in device usage and bladder relaxation techniques. Each session will last approximately 10 minutes and will be conducted 3-4 times during the initial instructional phase. The device will then be provided for home use at no cost. Caregivers will receive remote support from study physicians during the intervention period. Home-based training will include 5-10 sessions per day, each lasting 10 minutes. Daily records-including images of urine output, session duration, and any adverse events-will be uploaded to a secure cloud platform for physician review. The intervention will continue for 8 weeks. Monthly records of fluid intake and voiding behavior will be maintained throughout the study. Follow-up assessments, including voiding diaries and enuresis questionnaires, will be performed at 3 and 6 months post-intervention to assess recurrence and long-term outcomes. The sham group will follow identical baseline and training schedules; however, the device will remain inactive during each session. After 4 weeks, participants in this group will submit fluid intake and voiding records. Primary outcome measures include the enuresis improvement rate, frequency of daytime urinary incontinence, and total number of voiding episodes within 24 hours. Secondary outcomes will include: scores for the micturition desire-awakening function, timing of enuresis events, bedtime and wake time, standardized bladder capacity, bladder variability rate, behavioral responses during incontinence, psychological/behavioral characteristics, and enuresis recurrence.

Conditions

• Daytime Urinary Incontinence
• Urinary Frequency
• Lower Urinary Tract Dysfunction
• Primary Nocturnal Enuresis

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-06-03
• Last updated: 2025-06-05

Locations

1 site across 1 country: China