Urinary Biomarkers in Overactive Bladder in Children

NCT ID: NCT02704013

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type OTHER

Oxybutynin

Intervention Type DRUG

Anticholinergic

Interventions

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Oxybutynin

Anticholinergic

Intervention Type DRUG

Other Intervention Names

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Driptane

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital for Infectious Diseases, Croatia

OTHER

Sponsor Role collaborator

Children's Hospital Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Slaven Abdovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Zagreb

Locations

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Children's Hospital Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Central Contacts

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Slaven Abdovic, MD, PhD

Role: CONTACT

+385911144333

Other Identifiers

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pOAB-CHZ-01

Identifier Type: -

Identifier Source: org_study_id

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