Status:

NOT_YET_RECRUITING

A Cohort Study on Treating Primary Nocturnal Enuresis by Regulating Central-Peripheral Circadian Rhythm

Lead Sponsor:

Shanghai Children's Medical Center

Conditions:

Primary Nocturnal Enuresis

Eligibility:

All Genders

5-15 years

Phase:

NA

Brief Summary

Primary nocturnal enuresis (PNE), a prevalent pediatric disorder, suffers from therapeutic limitations characterized by low efficacy and high relapse rates. Targeting its core pathophysiology could si...

Detailed Description

The intervention training will last for 6 months. Researchers will compare the therapeutic efficacy of the "Circadian Rhythm Intervention Combined with Bladder Training Group (treatment group)" and th...

Eligibility Criteria

Inclusion

  • Diagnosis according to the ICCS criteria:
  • 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.
  • Age: 5 to 15 years (inclusive), regardless of gender.
  • Right-handedness (as assessed by the Annett Hand Preference Questionnaire)

Exclusion

  • Secondary nocturnal enuresis;
  • History of head trauma, neurological disorders, psychosurgery, or major physical conditions (including autism spectrum disorder, epilepsy, cerebral palsy);
  • Contraindications to fMRI.
  • Note: Mild comorbidities commonly associated with primary nocturnal enuresis (e.g., ADHD) are permitted but must be included as covariates in statistical analyses.

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2028

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT07003126

Start Date

July 1 2025

End Date

June 1 2028

Last Update

June 4 2025

Active Locations (1)

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Shanghai children's medical center

Shanghai, Shanghai Municipality, China, 200127