Urinary Biomarkers in Overactive Bladder in Children

Children's Hospital Zagreb

Status: Unknown

Conditions: Overactive Bladder

Treatments: Drug: Oxybutynin

Study type: Interventional

Funder types: Other

Identifiers

NCT02704013

pOAB-CHZ-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention

Other group

Description:

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.

Treatment:

Drug: Oxybutynin