Overactive BladderFABULUSNCT03625492
Fluids Affecting Bladder Urgency and Lower Urinary Symptoms
A study testing Reducing Potentially Irritating Beverages and Adopting the USDA Healthy Eating Habits in people with Overactive Bladder and Urinary Urgency, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urgency, Urinary Bladder, Overactive
- What is being tested?
- Reducing Potentially Irritating Beverages and Adopting the USDA Healthy Eating Habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 17 Sep 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 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.
Who cannot join
- Men
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
About this study
Official title: Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder, Urinary Urgency, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Caffeine, Alcohol Drinking
- Being tested
- Reducing Potentially Irritating Beverages, Adopting the USDA Healthy Eating Habits
- Keywords
- artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Alcohol Drinking, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Potentially Irritating BeveragesBehavioural
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.
Adopting the USDA Healthy Eating HabitsBehavioural
This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
| Study group | Role | What they receive |
|---|---|---|
| Reduce Potentially Irritating Beverages | Experimental | 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. Receives: Behavioral: Reducing Potentially Irritating Beverages |
| Adopt Healthy Eating Habits | Active comparator | This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating. Receives: Behavioral: Adopting the USDA Healthy Eating Habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urination frequency on 3-day bladder diary
Average number of times urinated per day on 3-day bladder diary
Measured: 2-weeks
Secondary outcomes (5)
Volume of urine per toileting event
Average volume of urine per day with each toileting event on 3-day bladder diary
Measured: 2-weeks
Daily urination urgency symptoms (Adapted from Bower et al 2001)
The adapted question reads, "Typically, when you needed to go to the bathroom today you could…" with the five potential responses ranging from "make the urge go away" to "already feel the urine coming out." Urgency will be measured as the mean reported score for each three-day time period for the perception of bladder fullness questionnaires.
Measured: 2-weeks
Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)
On 3-day diary, participants will be asked to indicate their perception of bladder fullness when they urinated that day: "no bladder sensation," "urinating could easily be delayed for more than 30-60 minutes," "urinating could only be delayed for 30 minutes," "urinating could only be delayed for 5 minutes" and "immediate urinating will be mandatory and/or fear of leakage."
Measured: 2-weeks
Bother associated with bladder symptoms (Coyne 2002)
The investigators will use only the "bother" questions of this larger Questionnaire about bladder symptoms. We modified the original think-back period of 4-weeks to instead think back to "the past 3 days" to characterize the bother of bladder symptoms under the varying conditions of each specific intervention period. Bother will be measured on the final day on the bottom of each of the 3-day diaries.
Measured: 2-months
Urination frequency on 3-day diary (longer-term effect)
Average number of times urinated per day on 3-day bladder diary
Measured: 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start7 Aug 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation, Arbor Research Collaborative for Health
- Responsible party
- Principal investigator, Janis Miller, University of Michigan
- Investigators
- Janis M Miller, PhD, Principal investigator, University of MichiganMegan O Schimpf, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625492
- Sponsor's protocol ID
- HUM00148419
- Acronym
- FABULUS
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bower WF, Moore KH, Adams RD. A pilot study of the home application of transcutaneous neuromodulation in children with urgency or urge incontinence. J Urol. 2001 Dec;166(6):2420-2.
PubMed 11696802Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
PubMed 12206577De Wachter S, Wyndaele JJ. Frequency-volume charts: a tool to evaluate bladder sensation. Neurourol Urodyn. 2003;22(7):638-42. doi: 10.1002/nau.10160.
PubMed 14595606
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms
- ClinicalTrials.gov ID
- NCT03625492
- Acronym / sponsor ID
- FABULUS / HUM00148419
- Conditions
- Overactive Bladder, Urinary Urgency, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Caffeine, Alcohol Drinking
- Keywords
- artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation, Arbor Research Collaborative for Health
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduce Potentially Irritating Beverages | Experimental | Behavioral: Reducing Potentially Irritating BeveragesThis 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. |
| Adopt Healthy Eating Habits | Active comparator | Behavioral: Adopting the USDA Healthy Eating HabitsThis group will receive a 7 minute video teaching them the USDA guidelines for healthy eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 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.
Key exclusion criteria (5 listed)
- Men
- 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
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 |
|---|---|---|
| Reducing Potentially Irritating BeveragesThis 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. | Behavioural | Reduce Potentially Irritating Beverages |
| Adopting the USDA Healthy Eating HabitsThis group will receive a 7 minute video teaching them the USDA guidelines for healthy eating. | Behavioural | Adopt Healthy Eating Habits |
Primary outcome
Urination frequency on 3-day bladder diary
Time frame: 2-weeks
Average number of times urinated per day on 3-day bladder diary
5 secondary outcomes
Volume of urine per toileting event
Time frame: 2-weeks
Daily urination urgency symptoms (Adapted from Bower et al 2001)
Time frame: 2-weeks
Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)
Time frame: 2-weeks
Bother associated with bladder symptoms (Coyne 2002)
Time frame: 2-months
Urination frequency on 3-day diary (longer-term effect)
Time frame: 2-months
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 14 Nov 2019.
- Background: PubMed 11696802Bower WF, Moore KH, Adams RD. A pilot study of the home application of transcutaneous neuromodulation in children with urgency or urge incontinence. J Urol. 2001 Dec;166(6):2420-2.
- Background: PubMed 12206577Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
- Background: PubMed 14595606De Wachter S, Wyndaele JJ. Frequency-volume charts: a tool to evaluate bladder sensation. Neurourol Urodyn. 2003;22(7):638-42. doi: 10.1002/nau.10160.
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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.
Janis M Miller, PhD principal investigator
University of Michigan
Megan O Schimpf, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Potentially Irritating Beverages and Adopting the USDA Healthy Eating Habits in people with Overactive Bladder and Urinary Urgency, run by University of Michigan 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 5 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 14 Nov 2019. 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. 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?
Urination frequency on 3-day bladder diary (time frame: 2-weeks). 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 NCT03625492, which also lists 3 linked publications.
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 14 Nov 2019.