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| Name | Class |
|---|---|
| University Hospital for Infectious Diseases, Croatia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | Anticholinergic |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Slaven Abdovic, MD, PhD | Contact | +385911144333 | sabdovic@gmail.hr |
| Name | Affiliation | Role |
|---|---|---|
| Slaven Abdovic, MD, PhD | Children's Hospital Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Zagreb | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |