"The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Women's Studies |
| Therapuetic Areas: | Gastroenterology, Reproductive |
| Healthy: | No |
| Age Range: | 58 - Any |
| Updated: | 10/27/2018 |
| Start Date: | July 2014 |
| End Date: | September 20, 2018 |
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:
1. The voiding and mental health symptoms will be greatest in the high dose treatment and
lowest in the placebo treatment.
2. The low dose treatment will produce more voiding and mental health symptoms than the
placebo treatment.
3. Voiding and mental health symptoms will be mediated by hydration status of the patient
which will be assessed using a Tanita Scale.
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:
1. The voiding and mental health symptoms will be greatest in the high dose treatment and
lowest in the placebo treatment.
2. The low dose treatment will produce more voiding and mental health symptoms than the
placebo treatment.
3. Voiding and mental health symptoms will be mediated by hydration status of the patient
which will be assessed using a Tanita Scale.
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
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Loma Linda, California 92354
Principal Investigator: Andrea Staack, MD
Phone: 909-558-4196
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