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

NCT07496541 | Not Yet Recruiting

• 1 other identifier: 2026-IRB-0096-P-01
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Monosymptomatic Nocturnal Enuresis; Copeptin

Outcome Measures

Primary Outcomes (1)

• serum concentration of copeptin in patients with PMNE(day and night)

  The serum concentration of copeptin in patients with PMNE to evaluate the copetin level between PMNE and healthy volunteers.

  Day 1

Study Arms (3)

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

Interventions

Testing the level of copeptin in patients with NNP-PMNE DIAGNOSTIC_TEST

Testing the level of copeptin in patients with NNP-PMNE

patients with NNP-PMNE

Testing the level of copeptin in healthy children DIAGNOSTIC_TEST

Testing the level of copeptin in healthy children

healthy volunteers

copeptin levels in NP-PMNE DIAGNOSTIC_TEST

Testing the level of copeptin in patients with NP-PMNE

patients with NP-PMNE

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary monosymptomatic nocturnal enuresis

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Central Study Contacts

Mao Jianhua

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03