Urinary Biomarkers in Overactive Bladder in Children

Children's Hospital Zagreb50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

OxybutyninDRUG

Anticholinergic

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Zagreb

Zagreb, Croatia

Outcomes

Primary Outcomes

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.

Time frame: 6 months after start of intervention

Secondary Outcomes

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.

Time frame: 6 months after stop of intervention

Bladder wall thickness

Bladder wall thickness will be measured using ultrasonography.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Slaven Abdovic, MD, PhD

CONTACT

+385911144333 sabdovic@gmail.hr

Data from ClinicalTrials.gov

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