Urinary Biomarkers in Overactive Bladder in Children

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

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 Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Oxybutynin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Slaven Abdovic, MD, PhD; Phone Number: +385911144333; Email: sabdovic@gmail.hr

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Children's Hospital Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Drug: Oxybutynin; Anticholinergic; 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

Collaborators and Investigators

• Sponsor: Children's Hospital Zagreb
• Collaborators: University Hospital for Infectious Diseases, Croatia

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Children; Urodynamics; Neurotrophins; Brain-Derived Neurotrophic Factor; Nerve Growth Factor; Anticholinergics; Urinary Biomarkers
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin
• Other Study ID Numbers: pOAB-CHZ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED