Back to resultsUrinary Biomarkers in Overactive Bladder in Children
Primary Purpose
Overactive Bladder
Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Oxybutynin
Sponsored by
About this trial
This is an interventional diagnostic trial for Overactive Bladder focused on measuring Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Zagreb
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Bladder wall thickness
Bladder wall thickness will be measured using ultrasonography.
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.
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.
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.
Urodynamics
Urodynamic study will be investigated prior and 6 months after start of intervention. Maximum detrusor pressure will be assessed.
Full Information
NCT ID
NCT02704013
First Posted
March 4, 2016
Last Updated
March 9, 2016
Sponsor
Children's Hospital Zagreb
Collaborators
University Hospital for Infectious Diseases, Croatia
1. Study Identification
Unique Protocol Identification Number
NCT02704013
Brief Title
Urinary Biomarkers in Overactive Bladder in Children
Official Title
Role of Urinary Neurotrophin and Cytokine Levels in Diagnosis and Management of Overactive Bladder in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Zagreb
Collaborators
University Hospital for Infectious Diseases, Croatia
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Driptane
Intervention Description
Anticholinergic
Primary Outcome Measure Information:
Title
Initial success
Description
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 Outcome Measure Information:
Title
Long-term success
Description
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
Title
Bladder wall thickness
Description
Bladder wall thickness will be measured using ultrasonography.
Time Frame
6 months after start of intervention
Title
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Description
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
Title
Urinary neurotrophins
Description
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
Title
Urinary cytokines
Description
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.
Time Frame
6 months after start of intervention
Title
Urodynamics
Description
Urodynamic study will be investigated prior and 6 months after start of intervention. Maximum detrusor pressure will be assessed.
Time Frame
6 months after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Slaven Abdovic, MD, PhD
Phone
+385911144333
Email
sabdovic@gmail.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Slaven Abdovic, MD, PhD
Organizational Affiliation
Children's Hospital Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Urinary Biomarkers in Overactive Bladder in Children
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