| Registry | NCT07496541 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 180 (Estimated) |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine (Other) |
| Conditions | Primary Monosymptomatic Nocturnal Enuresis, Copeptin |
| Interventions | copeptin levels in NP-PMNE, Testing the level of copeptin in patients with NNP-PMNE, Testing the level of copeptin in healthy children (Diagnostic test) |
| Dates | start 2026-03-17 (estimated), primary completion 2028-12-31 (estimated), completion 2029-01-31 (estimated), first posted 2026-03-27, last updated 2026-03-27 |
Related Papers Related Patents Related Grants Related Experts
All trials for Primary Monosymptomatic Nocturnal Enuresis All trials for Copeptin All trials of copeptin levels in NP-PMNE All trials of Testing the level of copeptin in patients with NNP-PMNE
Primary monosymptomatic nocturnal enuresis (PMNE) is one of the most common urinary system problems in childhood. The exact pathological mechanism has not been fully elucidated yet, but excessive nocturnal urination is considered one of the core pathogenic mechanisms. Studies have found that a considerable number of PMNE patients have abnormal secretion of arginine vasopressin (AVP) at night. Currently, the "gold standard" for diagnosing nocturnal polyuria is through a voiding diary, which is cumbersome and the records may contain errors, and there are many inconveniences in clinical implementation. Therefore, finding objective and simple biomarkers to assist in diagnosis and classification is a current clinical research hotspot. Copeptin is the C-terminal fragment of the precursor protein of AVP and is released into the blood simultaneously at the same molar ratio as AVP, making it an ideal alternative biomarker for AVP. This study aims to systematically and deeply explore the diagnostic value of serum copeptin in PMNE, especially in its different subtypes (NP-PMNE vs. NNP-PMNE), analyze its correlation with clinical severity, and explore more precise detection strategies, in order to provide new and objective biological tools for the clinical management of PMNE.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| patients with NNP-PMNE | Diagnostic Test: Testing the level of copeptin in patients with NNP-PMNE | ||
| patients with NP-PMNE | Diagnostic Test: copeptin levels in NP-PMNE | ||
| healthy volunteers | Diagnostic Test: Testing the level of copeptin in healthy children |
Sex: All, ages: 5 Years to 18 Years, accepts healthy volunteers
Inclusion Criteria: * 1.Age 5-18 years old. 2. No treatment has been received within 1 month prior to the trial. 3. Able to complete a 7-night urine diary and relevant research questionnaires for 2 days. 4. Guardians and the child themselves have agreed to participate in the study and have signed the informed consent form. 5. Meet the diagnostic criteria for PMNE as defined in the 2025 nocturnal enuresis guidelines: Age ≥ 5 years old, at least 1 episode of involuntary nocturnal urination per month for more than 3 months, without daytime lower urinary tract symptoms and organic urinary system disorders. Exclusion Criteria: * 1\. Patients under the age of 5; 2. Patients with daytime lower urinary tract symptoms or history of bladder dysfunction; 3. Patients with secondary nocturnal enuresis who have experienced at least 6 months of dry bed period; 4. Patients with chronic diseases.