Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Micturition Desire-Relaxation Training Device, Sham device.
- Who it may be relevant to
- Registry conditions: Daytime Urinary Incontinence, Urinary Frequency, Lower Urinary Tract Dysfunction, Primary Nocturnal Enuresis. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Enuresis improvement rate [Time frame: From enrollment to the end of treatment at 6 months]
- Daytime urinary incontinence frequency [Time frame: From enrollment to the end of treatment at 6 months]
- Total number of voiding episodes in 24 hours [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (8)
- Grade scoring of the micturition desire - awakening function [Time frame: From enrollment to the end of treatment at 6 months]
- Enuresis recurrence rate [Time frame: From enrollment to the end of treatment at 6 months]
- Timing of nocturnal enuresis episodes [Time frame: From enrollment to the end of treatment at 6 months]
- Child's bedtime and wake time [Time frame: From enrollment to the end of treatment at 6 months]
- Standardized bladder capacity [Time frame: From enrollment to the end of treatment at 6 months]
- Bladder variability rate [Time frame: From enrollment to the end of treatment at 6 months]
- Behavioral response during daytime urinary incontinence episodes [Time frame: From enrollment to the end of treatment at 6 months]
- Child's psychological and behavioral characteristics [Time frame: Assessed every 3 months from enrollment to the end of treatment at 6 months]
Eligibility criteria
Inclusion criteria
- Diagnosis according to the ICCS criteria:
For nocturnal enuresis:
At least one episode of involuntary nighttime urination per month for more than 3 months.
No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.
For daytime urinary incontinence:
At least one episode of intermittent urinary leakage during wakefulness per month for more than 3 months.
No anatomical or neurological causes of urinary incontinence.
For urinary frequency:
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.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Micturition Desire-Relaxation Training — Shanghai
Publications
- Bergmann M, Corigliano T, Ataia I, Renella R, Simonetti GD, Bianchetti MG, von Vigier RO. Childhood extraordinary daytime urinary frequency-a case series and a systematic literature review. Pediatr Nephrol. 2009 Apr;24(4):789-95. doi: 10.1007/s00467-008-1082-9. Epub 2008 Dec 18. PMID 19093136
- Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Ep PMID 24508614
Identifiers
NCT: NCT07000656 · MR-31-24-03