"The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in voiding symptoms
研究概览
简要总结
The purpose of this study is to observe effects of caffeine on overactive bladder symptoms and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or if lower doses of caffeine decrease the effects.
The study will propose the following hypothesis:
- The voiding and mental health symptoms will be greatest in the high dose treatment and lowest in the placebo treatment.
- The low dose treatment will produce more voiding and mental health symptoms than the placebo treatment.
- Voiding and mental health symptoms will be mediated by hydration status of the patient which will be assessed using a Tanita Scale.
详细描述
Subjects will be exposed to 200 mg and 400 mg caffeine pills and placebo pills (free of caffeine). During each treatment period, participants will be required to avoid caffeine (except for the caffeine within the given treatment). The study is staged into 3 phases, which will last for 7 days each. After enrollment, participants will be asked to refrain from consuming any substances containing caffeine during the 21 days of treatment. Instead of coffee or other caffeine items, they will be exposed to caffeine in pill form. Participants will complete each treatment in a random, cross over blinded fashion. One phase of treatment will have participants consume two 200 mg-caffeine pills a day (total of 400 mg of caffeine/day), a second treatment will have participants consume one 200 mg-caffeine pill and one placebo pill a day. And the final treatment will have participants consume two placebo pills each day. Treatment phases will be assigned randomly to each participant. The participant will not know which phase they are receiving.
Prior to the treatment, the participant will be asked to fill out a detailed diet log of her eating and drinking habits. Participants will also be asked a series of questions on a survey related to bladder symptoms and mental health periodically throughout the study. It will take about 30 minutes of their time to answer the questionnaires at individual time points.
During the 21 days of the study period participants will be asked to self-monitor fluid intake and note any major changes of fluid intake compared to the initial intake log. They will be asked to conduct a 24-hour voiding and defecation log at two different time points within each treatment phase as well as prior to the study. 24-hour urine will be collected during each treatment phase at two different time points as well as prior to the study. Participants weight and lean body mass will be assessed in clinic using a Tanita scale at two times within each treatment phase and one time prior to the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 58 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low to moderate coffee drinkers (between 1-3 cups/day, or 50-450mg caffeine/d)
- •Able to communicate and read in English
- •58 years of age or older
- •Post-menopausal
排除标准
- •Excessive coffee drinkers (>450 mg/d)
- •Individual who do not regularly consume caffeine
- •Uncontrolled hypertension
- •Vaginal pain
- •Chronic pelvic pain/ Interstitial cystitis
- •Pre- or perimenopausal
研究组 & 干预措施
400 mg of caffeine/day (Two 200mg pills/day)
One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.
干预措施: 400 mg of caffeine/day (Two 200mg pills/day) (Dietary Supplement)
200 mg of caffeine/day (One 200mg pill and one placebo pill)
This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)
干预措施: 200 mg of caffeine/day (One 200mg pill and one placebo pill) (Dietary Supplement)
Two placebo pills/day
This arm will have participants consume two placebo pills each day.
干预措施: Two placebo pills/day (Dietary Supplement)
结局指标
主要结局
Change in voiding symptoms
时间窗: Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.
Voiding symptoms will be measured through a composite of self-reported surveys. These surveys are the King's Health Questionnaire, Urinary Distress Inventory, Overactive Bladder Symptom Score, Overactive Bladder Questionnaire.
Change in mental health
时间窗: Mental health symptoms will be measured 6 times throughout the 21-day trial, as well as a baseline measure one time pre-trial.
Mental health symptoms will be measured through a composite of self-reported surveys. These surveys are the Insomnia Severity Index, Stress Quiz, Beck Anxiety Index, Beck Depression Inventory, The Positive and Negative Affect Scales, Rosenberg Self-Esteem Scale, and the International Physical Activity Questionnaire.
次要结局
未报告次要终点