Clinically Important or Just Statistically Significant? Minimal Clinically Important Difference for DVISS and PIN-Q in Children With Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
研究概览
简要总结
The goal of this study was to determine the Minimal Clinically Important Difference (MCID) for the Dysfunctional Voiding and Incontinence Symptom Score (DVISS) and the Pediatric Incontinence Questionnaire (PIN-Q) in children with urinary incontinence (UI).
详细描述
100 children with UI will receive standard urotherapy (SU) for 8 weeks. UI-related symptoms and quality of life (QoL) will be assessed with the DVISS and PIN-Q baseline and after treatment. The receiver operating characteristic (ROC) analysis and the Gamma coefficient will be employed to assess responsiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of UI according to the International Children's Continence Society (ICCS) Guideline,
- •children aged 5-13 years (when UI becomes more prevalent in children).
排除标准
- •congenital anomalies of the uro-genital system,
- •only neurogenic bladder dysfunction.
结局指标
主要结局
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
时间窗: Baseline
DVISS includes 14 items: 13 assess lower urinary tract symptoms (LUTS), voiding and defecation habits day and night, and one evaluates impact on severity and daily life activities (DLA). A score of 8.5+ indicates abnormal voiding; higher scores mean more severe disease.
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
时间窗: At Week 8, immediately after completion of the 8-week intervention
DVISS includes 14 items: 13 assess lower urinary tract symptoms (LUTS), voiding and defecation habits day and night, and one evaluates impact on severity and daily life activities (DLA). A score of 8.5+ indicates abnormal voiding; higher scores mean more severe disease.
次要结局
- Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)(Baseline)
- Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)(At Week 8, immediately after completion of the 8-week intervention)
研究者
Zeynep Yıldız Kızkın
Lecturer
Artvin Coruh University