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Completed

NCT Number: NCT06785558

The Role of Urinary ATP in the Diagnosis, Treatment, and Follow-up of Children With Overactive Bladder

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine Urology Department

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is under 18 years of age
  • OAB symptoms may be accompanied by frequent urination, urgency, and urinary incontinence

Exclusion criteria

  • Neurological disease
  • malignancy
  • active urinary tract infection
  • bladder anomaly (uroterocele, diverticulum),
  • LUS obstruction, ectopic ureter
  • history of previous urological surgery

Treatment and study plan

Anticholinergic therapy

Drug

Overactive bladder group use anticholinergic drug and 1 month later their urinary atp levels calculated again

Primary outcomes

  1. Urinary ATP levels

    Time frame: Baseline

Secondary outcomes

  1. Urinary ATP levels

    Time frame: 1 month

    Measured only overactive bladder group

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

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.

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