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Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis

Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07496541
Enrollment
180
Registered
2026-03-27
Start date
2026-03-17
Completion date
2029-01-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copeptin, Primary Monosymptomatic Nocturnal Enuresis

Brief summary

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.

Interventions

DIAGNOSTIC_TESTcopeptin levels in NP-PMNE

Testing the level of copeptin in patients with NP-PMNE

DIAGNOSTIC_TESTTesting the level of copeptin in patients with NNP-PMNE

Testing the level of copeptin in patients with NNP-PMNE

DIAGNOSTIC_TESTTesting the level of copeptin in healthy children

Testing the level of copeptin in healthy children

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
serum concentration of copeptin in patients with PMNE(day and night)Day 1The serum concentration of copeptin in patients with PMNE to evaluate the copetin level between PMNE and healthy volunteers.

Contacts

CONTACTMao Jianhua

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026