Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT07000656
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT07000656
Study Brief:
Protocol Section:
NCT07000656