Bladder Training Video Versus Individual Urotherapy for Children With Non-neurogenic Lower Urinary Tract Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms
研究概览
简要总结
Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental health and its potential negative clinical sequelae, which includes upper or lower urinary tract damage, must be taken into account when treating these children. These patients have complex needs requiring a significant amount of health teaching and it is imperative to determine the effectiveness of the various modes of delivering urotherapy. To determine the best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute bladder training video to the effectiveness of standard urotherapy provided at a pediatric urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years old
- •Bladder Dysfunction (Diagnosis of NLUTD or DES)
排除标准
- •Grade 3 or 4 hydronephrosis
- •Grade 3, 4 or 5 vesicoureteral reflux
- •Other diagnoses which affect bladder bowel function (i.e. Spina Bifida)
- •English as a second language
- •Diagnosed learning disability (i.e. ADD or ADHD)
- •Mental health condition (i.e. anxiety or depression)
- •Received intensive urotherapy and biofeedback in past 12 months
- •Child is diagnosed with primary nocturnal enuresis
研究组 & 干预措施
Standard Invididual Urotherapy
Educational Intervention. Standard individual urotherapy (bladder re-training) occurs in the pediatric urology clinic.
干预措施: Educational Intervention (Other)
Bladder Training Video
Experimental Educational Intervention. Participants will watch a 7 minute animated bladder training video.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms
时间窗: up to 12 weeks
Determine improvement of Nonneurogenic Lower Urinary Tract Dysfunction symptoms according to the Vancouver NLUTD/DES questionnaire after administration of either intervention (Bladder Training Video or standard urotherapy)
次要结局
- Assess the Quality of Life of children with Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome.(Up to 12 weeks)