Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic … (NCT07496541) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis
180 participantsStarted 2026-03-17
Plain-language 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.
Who can participate
Age range
5 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
serum concentration of copeptin in patients with PMNE(day and night)
Timeframe: Day 1
Trial details
NCT IDNCT07496541
SponsorThe Children's Hospital of Zhejiang University School of Medicine