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

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · May 24, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device called the Micturition Desire-Relaxation Training Device, designed to help children who experience problems with urinary control, such as daytime urinary incontinence or frequent urination. The study aims to see if training the body to link the feeling of needing to urinate with relaxation can improve how well the bladder works. Children aged 5 to 18 years who have certain types of urinary issues may be eligible to participate, as long as their conditions aren't caused by other medical problems like infections or neurological disorders.

If your child participates, they will learn to use the device to help them manage their urinary symptoms better. The trial is currently recruiting participants, and both the child and their guardian must agree to join and sign a consent form. This study offers a chance to explore a novel approach to urinary issues that may help improve your child’s quality of life.

Gender

ALL

Eligibility criteria

• 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.