Urinary Biomarkers in Overactive Bladder in Children

Study Overview
=================
Brief Summary
-----------------
It is a single-center, prospective, interventional, single-arm study. Aim is to investigate which variables are significantly correlated with prolonged anticholinergic treatment (>6 months) in children with overactive bladder (OAB). Investigated variables will include urinary neurotrophins and inflammatory cytokines, sonographic biomarkers, symptom score scale, demographics, and urodynamic findings. Secondary aim is to analyze sensitivity and specificity of urinary biomarkers in diagnosis and management of OAB compared to urodynamics and treatment outcome.

Official Title
-----------------
Role of Urinary Neurotrophin and Cytokine Levels in Diagnosis and Management of Overactive Bladder in Children

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Oxybutynin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: urgency with or without frequency, incontinence, enuresis, or nocturia an unremarkable clinical examination a minimum of 3 micturitions per day informed oral and written consent from the child and both parents/legal guardian Exclusion Criteria: acute urinary tract infection diseases of central or peripheral nerve system anomalies of lumbosacral region bladder outlet obstruction operative procedures or anomalies of urinary or genital tract hypercalcuria, diabetes mellitus, diabetes insipidus neurogenic bladder constipation or fecal incontinence urolithiasis, depression, eating disorders or cardio-metabolic diseases prior use of anticholinergic treatment during the last year

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Patients with overactive bladder will receive anticholinergic therapy: oral oxybutynin in daily dose 0.2-0.5 mg/kg divided in two daily doses for 3 to 6 months depending on treatment outcome assessed 3 months after start of intervention. | Drug: Oxybutynin<br>* Anticholinergic<br>* Other names: Driptane;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial success | Nonresponse is defined as a 0% to 49% decrease, partial response is defined as a 50% to 89% decrease, response is defined as a 90% or greater decrease and full response is defined as a 100% decrease or less than 1 symptom occurrence monthly. Symptoms include urgency, daily incontinence, increased daytime frequency, enuresis, nocturia. Symptom frequency will be assessed using validated diary. | 6 months after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term success | Relapse is defined as more than 1 symptom recurrence monthly, continued success is de-fined as no relapse in 6 months after the interruption of treatment. | 6 months after stop of intervention | 
| Bladder wall thickness | Bladder wall thickness will be measured using ultrasonography. | 6 months after start of intervention | 
| Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire | Improvement is defined by increase in total and subscale scores by more than defined minimally clinical important difference for PedsQL 4.0 Generic Core questionnaire. | 6 months after start of intervention | 
| Urinary neurotrophins | Urine samples will be collected at urge sensation before and 6 months after start of intervention. Urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) levels normalized to urinary creatinine will be measured. | 6 months after start of intervention | 
| Urinary cytokines | Urine samples will be collected at urge sensation before and 6 months after start of intervention. Urinary inflammatory cytokines (MCP-1, MCP-2, MCP-3, CaCL-13) levels normalized to urinary creatinine will be measured. | 6 months after start of intervention | 
| Urodynamics | Urodynamic study will be investigated prior and 6 months after start of intervention. Maximum detrusor pressure will be assessed. | 6 months after start of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children