Role of Urinary Neurotrophin and Cytokine Levels in Diagnosis and Management of Overactive Bladder in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Initial success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oxybutynin (Drug)
结局指标
主要结局
Initial success
时间窗: 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.
次要结局
- Long-term success(6 months after stop of intervention)
- Urinary cytokines(6 months after start of intervention)
- Bladder wall thickness(6 months after start of intervention)
- Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire(6 months after start of intervention)
- Urinary neurotrophins(6 months after start of intervention)
- Urodynamics(6 months after start of intervention)