Overactive BladderNCT02180048
"The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
A study testing 400 mg of caffeine/day (Two 200mg pills/day) in people with Overactive Bladder and Caffeine, run by Loma Linda University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 58 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Caffeine, Menopause
- What is being tested?
- 400 mg of caffeine/day (Two 200mg pills/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Urology, Loma Linda University
Loma Linda, California, 92354
About this study
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.
Read the detailed description
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
- Conditions
- Overactive Bladder, Caffeine, Menopause
- Being tested
- 400 mg of caffeine/day (Two 200mg pills/day), 200 mg of caffeine/day (One 200mg pill and one placebo pill), Two placebo pills/day
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg of caffeine/day (Two 200mg pills/day)Dietary supplement
One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.
200 mg of caffeine/day (One 200mg pill and one placebo pill)Dietary supplement
This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)
Two placebo pills/dayDietary supplement
This arm will have participants consume two placebo pills each day.
| Study group | Role | What they receive |
|---|---|---|
| 400 mg of caffeine/day (Two 200mg pills/day) | Active comparator | One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days. Receives: Dietary Supplement: 400 mg of caffeine/day (Two 200mg pills/day) |
| 200 mg of caffeine/day (One 200mg pill and one placebo pill) | Active comparator | This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill) Receives: Dietary Supplement: 200 mg of caffeine/day (One 200mg pill and one placebo pill) |
| Two placebo pills/day | Placebo comparator | This arm will have participants consume two placebo pills each day. Receives: Dietary Supplement: Two placebo pills/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in voiding symptoms
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.
Measured: Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.
Change in mental health
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.
Measured: Mental health symptoms will be measured 6 times throughout the 21-day trial, as well as a baseline measure one time pre-trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Staack, MD, Principal investigator, Loma Linda University, Urology Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180048
- Sponsor's protocol ID
- 5130411
- Status last verified
- Oct 2018
- First submitted
- 27 Jun 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Staack A, Distelberg B, Moldovan C, Belay RE, Sabate J. The Impact of Caffeine Intake on Mental Health Symptoms in Postmenopausal Females with Overactive Bladder Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial. J Womens Health (Larchmt). 2022 Jun;31(6):819-825. doi: 10.1089/jwh.2021.0467. Epub 2022 Apr 1.
PubMed 35363563
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
- ClinicalTrials.gov ID
- NCT02180048
- Acronym / sponsor ID
- 5130411
- Conditions
- Overactive Bladder, Caffeine, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 mg of caffeine/day (Two 200mg pills/day) | Active comparator | Dietary Supplement: 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. |
| 200 mg of caffeine/day (One 200mg pill and one placebo pill) | Active comparator | 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) |
| Two placebo pills/day | Placebo comparator | Dietary Supplement: Two placebo pills/dayThis arm will have participants consume two placebo pills each day. |
Who may qualify
- Ages
- 58 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Excessive coffee drinkers (>450 mg/d)
- Individual who do not regularly consume caffeine
- Uncontrolled hypertension
- Vaginal pain
- Chronic pelvic pain/ Interstitial cystitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | 400 mg of caffeine/day (Two 200mg pills/day) |
| 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) | Dietary supplement | 200 mg of caffeine/day (One 200mg pill and one placebo pill) |
| Two placebo pills/dayThis arm will have participants consume two placebo pills each day. | Dietary supplement | Two placebo pills/day |
Primary outcome
Change in voiding symptoms
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Derived from this study: PubMed 35363563Staack A, Distelberg B, Moldovan C, Belay RE, Sabate J. The Impact of Caffeine Intake on Mental Health Symptoms in Postmenopausal Females with Overactive Bladder Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial. J Womens Health (Larchmt). 2022 Jun;31(6):819-825. doi: 10.1089/jwh.2021.0467. Epub 2022 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Staack, MD principal investigator
Loma Linda University, Urology Medical Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 mg of caffeine/day (Two 200mg pills/day) in people with Overactive Bladder and Caffeine, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in voiding symptoms (time frame: Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.