Caffeine Reduction Education And Overactive Bladder Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- urinary frequency, as measured on a 3-day voiding diary
研究概览
简要总结
A. Statement of Objective: To conduct a randomized trial to evaluate the impact of caffeine restriction on Overactive Bladder(OAB) symptoms including urinary frequency, nocturia, incontinence episodes, symptom severity and bother and quality of life.
B. Specific Aims/Hypothesis:
- To determine if reduction in caffeine intake decreases urinary frequency, nocturia and incontinence episodes as measured on a 3-day voiding diary in women with Overactive Bladder (OAB).
We hypothesize that women with overactive bladder will report less frequent urination and decreased nocturia and incontinence episodes with caffeine reduction. 2. To determine whether caffeine reduction results in decreased symptom severity and bother and improved quality of life scores as measured by the Questionnaire for Incontinence Severity Index (ISI), Questionnaire for Urinary Incontinence Diagnosis (QUID), Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7).
We hypothesize that women with OAB who reduce their intake of caffeine will report decreased symptom bother and improved quality of life as measured by the ISI, UDI-6 and the IIQ-
详细描述
Objective
To evaluate the impact of caffeine reduction education on urinary frequency.
Methods: Women with overactive bladder (OAB) symptoms who scored a 6 on the Questionnaire for Urinary Incontinence Diagnosis and who consumed at least 200 mg of caffeine daily were recruited. After completing baseline 3-day bladder diaries including amount and type of caffeine consumption, as well as validated urinary symptom severity, bother and quality of life questionnaires, women were randomized to receive caffeine reduction education vs. a control group who reviewed their voiding diary with no counseling to reduce caffeine; both groups were asked to maintain total fluid intake. Participants repeated the 3-day bladder diary and validated questionnaires following randomization. A total of 80 women were required to achieve 80% power with an alpha error of 0.05 to detect a difference of 1.3 in mean number of daily voids averaged over a 3-day voiding diary.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •only women 18 years and older with Overactive Bladder syndrome and who report that they consume an average of two cups of caffeinated beverages (approximately 200mg caffeine) daily will be included.
排除标准
- •Women presenting with stress predominate bladder symptoms as evaluated by the QUID, urinary tract infection or hematuria as evaluated on urine dip analysis, currently pregnant or pregnant within the past six months or history of radiation to the pelvic floor will be excluded from participation
结局指标
主要结局
urinary frequency, as measured on a 3-day voiding diary
时间窗: baseline and 2 - 4 weeks
次要结局
- Improved Quality of life scores(baseline and 2 - 4 weeks)