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

Обзор

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.

Вмешательства

• Диагностический тест copeptin levels in NP-PMNE
  Testing the level of copeptin in patients with NP-PMNE
• Диагностический тест Testing the level of copeptin in patients with NNP-PMNE
  Testing the level of copeptin in patients with NNP-PMNE
• Диагностический тест Testing the level of copeptin in healthy children
  Testing the level of copeptin in healthy children

Первичные конечные точки

• serum concentration of copeptin in patients with PMNE(day and night) [Срок оценки: Day 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07496541 · 2026-IRB-0096-P-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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