Overactive Bladder
Conditions
Keywords
Neurotrophins, Nerve Growth Factor, Brain-Derived Neurotrophic Factor, Urinary Biomarkers, Urodynamics, Anticholinergics, Children
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.
Interventions
DRUGOxybutynin
Anticholinergic
Sponsors
University Hospital for Infectious Diseases, Croatia
Children's Hospital Zagreb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Croatia
Contacts
Primary ContactSlaven Abdovic, MD, PhD
Outcome results
None listed