Relaxation-based bladder training device for children with daytime wetting, frequent urination, or bedwetting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, sham-controlled trial will enroll children with lower urinary tract dysfunction and use stratified block randomization by sex, age, and enuresis frequency to allocate participants 1:1 to the active device or a sham device. The first training session is supervised and caregivers receive standardized instruction, after which the device is used at home for an 8-week training period with frequent short sessions and remote physician support. Families keep daily records, upload urine images and session data to a secure cloud platform, and provide monthly fluid and voiding logs with follow-up extending to six months. Outcomes compare symptom frequency and bladder function between groups to determine clinical efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Age: 5 to 18 years (inclusive), regardless of gender.
3. Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. 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.
2. Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
3. Patients who have participated in or are currently participating in other clinical trials within the past month.
4. Patients deemed unsuitable for participation in the clinical trial by the investigator.

Where it's running

• Micturition Desire-Relaxation Training
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: jun ma
• Email: majun@shsmu.edu.cn
• Phone: 13917230745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.