Status:
RECRUITING
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
Lead Sponsor:
Shanghai Children's Medical Center
Conditions:
Daytime Urinary Incontinence
Urinary Frequency
Eligibility:
All Genders
5-18 years
Phase:
NA
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 ...
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07000656
Start Date
November 20 2024
End Date
May 31 2026
Last Update
June 5 2025
Active Locations (1)
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Micturition Desire-Relaxation Training
Shanghai, Shanghai Municipality, China, 200122