Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Urination frequency on 3-day bladder diary
研究概览
简要总结
This study evaluates whether eliminating certain ingredients (caffeine, alcohol, artificial sweeteners, acidic juices) consumed in beverages reduces bladder symptoms of urinary frequency and urgency. Women with overactive bladder will be recruited. Half of these women will receive instructions to replace beverages containing these ingredients with beverages such as water or milk. The other half of participants will receive instructions on following the United States Department of Agriculture guidelines on healthy eating.
详细描述
It is commonly believed that it is better for women's bladders if intake of certain beverages is eliminated. Advice is given to women with frequency/urgency symptoms to avoid coffee or tea, sodas or pop, or any other drinks that contain alcohol, caffeine, artificial sweeteners or high acidic content. Although the investigators do not know the direct cause and effect of consuming beverages with these ingredients, there might be reduction in "irritating" sensation to toilet often because of urgency if the beverages with these ingredients are replaced by "non-irritating" beverages.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Daily intake of at least 16 oz. of potentially irritating beverages, defined as drinks that are caffeinated, artificially sweetened, citric/acidic, or alcoholic beverages
- •Daily intake of at least 32 oz. of total beverages
- •At least two of the following three qualifications: urinating greater than on average seven times during waking hours on 3-day diary, urinating routinely more than two times at night, answering "yes" to experiencing frequent, strong feelings of urgency to empty the bladder.
排除标准
- •History of diabetes, spinal cord injury, multiple sclerosis, muscular dystrophy, cerebral palsy, dementia or Alzheimer's or stroke
- •Currently pregnant or within one year of delivery
- •Currently report symptoms of pain with urination or frequent urinary tract infections
- •Uses diuretic medications, currently taking medication prescribed for bladder symptoms or have had surgery for incontinence with the last 12 months
研究组 & 干预措施
Reduce Potentially Irritating Beverages
This group will receive a 7 minute video teaching participants to replace beverages that include caffeine, alcohol, artificial sweeteners, or acidic juices with equal volume intake of water, milk, or other beverages that do not have these ingredients in them.
干预措施: Reducing Potentially Irritating Beverages (Behavioral)
Adopt Healthy Eating Habits
This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
干预措施: Adopting the USDA Healthy Eating Habits (Behavioral)
结局指标
主要结局
Urination frequency on 3-day bladder diary
时间窗: 2-weeks
Average number of times urinated per day on 3-day bladder diary
次要结局
- Daily urination urgency symptoms (Adapted from Bower et al 2001)(2-weeks)
- Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)(2-weeks)
- Bother associated with bladder symptoms (Coyne 2002)(2-months)
- Urination frequency on 3-day diary (longer-term effect)(2-months)
- Volume of urine per toileting event(2-weeks)
研究者
Janis Miller
Professor
University of Michigan