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

NCT07000656 | Recruiting

• 1 other identifier: MR-31-24-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

• 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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (8)

• Grade scoring of the micturition desire - awakening function

  From enrollment to the end of treatment at 6 months

• Enuresis recurrence rate

  From enrollment to the end of treatment at 6 months

• Timing of nocturnal enuresis episodes

  From enrollment to the end of treatment at 6 months

• Child's bedtime and wake time

  From enrollment to the end of treatment at 6 months

• Standardized bladder capacity

  From enrollment to the end of treatment at 6 months

Study Arms (2)

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.

Device: Sham device

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.

Device: Micturition Desire-Relaxation Training Device

Interventions

Micturition Desire-Relaxation Training Device 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.

Micturition Desire-Relaxation Training

Sham device 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.

Sham Intervention Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Micturition Desire-Relaxation Training

Shanghai, Shanghai Municipality, 200122, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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. Epub 2014 Feb 4.

  PMID: 24508614 BACKGROUND

MeSH Terms

Conditions

Diurnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

jun ma

CONTACT

13917230745; majun@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)