Marmara University School of Medicine Urology Department
Istanbul, 34854, Turkey (Türkiye)
NCT Number: NCT06785558
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Looking for future studies?
Notify Me4 year–18 year
All sexes
Interventional
Not applicable
Istanbul, 34854, Turkey (Türkiye)
The diagnosis of OAB primarily relies on **medical history** and **physical examination**. Diagnosis is supported by appropriate laboratory findings and imaging methods. The role of various urinary biomarkers has been investigated as a non-invasive and simple diagnostic method. In recent years, research has focused on several biomarkers, particularly low-grade inflammatory mediators such as cytokines, Prostaglandin E2 (PGE2), Nerve Growth Factor (NGF), and Brain-Derived Neurotrophic Factor (BDNF). However, although these biomarkers are correlated with the severity of OAB symptoms, no studies have demonstrated their independent prognostic value.
For example, some studies report significant variability in urinary NGF levels, with not all patients showing increased urinary NGF. Other studies have noted that NGF correlates with OAB symptoms and decreases significantly after treatment. Consequently, no biomarker has yet been defined for routine clinical use. Moreover, biomarker studies specifically targeting pediatric OAB are limited, with most research focusing on adult populations and extrapolating findings to children.
Today, there is growing recognition of the role of purinergic transmission in urinary dysfunction. Purinergic transmission involves both afferent and efferent pathways in bladder emptying and has been implicated in the pathogenesis of detrusor overactivity (DO). In vitro studies have demonstrated that bladders with DO release higher amounts of Adenosine Triphosphate (ATP) from urothelium and cholinergic nerve terminals compared to normal bladders. Clinical studies suggest that urinary ATP levels could serve as a potential biomarker for OAB in adults. However, our literature review revealed that this biomarker has not yet been evaluated in children with OAB.
In this study, the investigators aim to evaluate the role of urinary ATP as a biomarker for the diagnosis, treatment, and follow-up of OAB in children for the first time in a clinical investigation, as previous research has been limited to adults.
Two midstream urine samples will collected from the OAB group: one pre-treatment and one at the first month of anticholinergic treatment. Urine samples will centrifuged, stored at -80°C, and ATP levels will measure via ELISA. Comparisons will make between the groups and pre-/post-treatment ATP levels in the OAB group. Correlation analysis will conduct between ATP levels and lower urinary system (LUS) parameters.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Overactive bladder group use anticholinergic drug and 1 month later their urinary atp levels calculated again
Time frame: Baseline
Time frame: 1 month
Measured only overactive bladder group
Marmara University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07736560
Ejaculation Abnormal, Female Urogenital Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07728747
Detrusor Overactivity, Female Urogenital Diseases
Gaziantep, Şahinbey, Turkey (Türkiye)
View Trial DetailsNCT07206446
Alzheimer Disease, Brain Diseases
Galway, Ireland
View Trial DetailsNCT05702294
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Birmingham, United Kingdom
View Trial Details