Urinary Biomarkers in Overactive Bladder in Children

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02704013
• Other study ID #: pOAB-CHZ-01
• Status: Not yet recruiting
• Phase: N/A
• First received: March 4, 2016
• Last updated: March 9, 2016
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Children's Hospital Zagreb
• Contact: Slaven Abdovic, MD, PhD
• Phone: +385911144333
• Email: sabdovic[@]gmail.hr
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin
Anticholinergic

Locations

Country	Name	City	State
Croatia	Children's Hospital Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Zagreb	University Hospital for Infectious Diseases, Croatia

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Bladder wall thickness	Bladder wall thickness will be measured using ultrasonography.	6 months after start of intervention	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No