Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- PPIUS urge-score
研究概览
简要总结
The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OAB patients
排除标准
- •benign prostatic hyperplasia
- •neurogenic detrusor overactivity
- •urine tract infection
- •anticholinergics
- •intravesical botulin toxin
- •cardiac failure
- •renal insufficiency
- •sacral neurostimulation
- •percutaneous neurostimulation
研究组 & 干预措施
low fluid intake
fluid intake 900 ml/day (+/- 300ml) for 2,5 days
干预措施: water (Dietary Supplement)
high fluid intake
2400 ml/day (+/- 300 ml )for 2,5 days
干预措施: water (Dietary Supplement)
normal fluid intake
1500 ml /day (+/- 300 ml) for 2,5 days
干预措施: water (Dietary Supplement)
结局指标
主要结局
PPIUS urge-score
时间窗: 2 days
urine osmolality
时间窗: 2 days
次要结局
- PPIUS urge score(2 days)
- urine pH(2 days)