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

March 23, 2026 updated by: The Children's Hospital of Zhejiang University School of Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mao Jianhua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary monosymptomatic nocturnal enuresis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
Diagnostic test: Testing the level of copeptin in healthy children
Testing the level of copeptin in healthy children
patients with NNP-PMNE
Diagnostic test: Testing the level of copeptin in patients with NNP-PMNE
Testing the level of copeptin in patients with NNP-PMNE
patients with NP-PMNE
Diagnostic test: copeptin levels in NP-PMNE
Testing the level of copeptin in patients with NP-PMNE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum concentration of copeptin in patients with PMNE(day and night)
Time Frame: Day 1
The serum concentration of copeptin in patients with PMNE to evaluate the copetin level between PMNE and healthy volunteers.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 17, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-IRB-0096-P-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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