Urinary Biomarkers in Overactive Bladder in Children

Sponsor

Children's Hospital Zagreb (Other)

Overall Status

Unknown status

CT.gov ID

NCT02704013

Collaborator

University Hospital for Infectious Diseases, Croatia (Other)

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Oxybutynin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Initial success [6 months after start of intervention]
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.

Secondary Outcome Measures

Long-term success [6 months after stop of intervention]
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.
Bladder wall thickness [6 months after start of intervention]
Bladder wall thickness will be measured using ultrasonography.
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire [6 months after start of intervention]
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.
Urinary neurotrophins [6 months after start of intervention]
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.
Urinary cytokines [6 months after start of intervention]
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.
Urodynamics [6 months after start of intervention]
Urodynamic study will be investigated prior and 6 months after start of intervention. Maximum detrusor pressure will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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