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Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03625492
Acronym
FABULUS
Enrollment
65
Registered
2018-08-10
Start date
2018-08-07
Completion date
2019-09-17
Last updated
2019-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Caffeine, Lower Urinary Tract Symptoms, Overactive Bladder, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Urgency

Keywords

artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms

Brief 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. 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.

Interventions

BEHAVIORALReducing Potentially Irritating Beverages

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.

BEHAVIORALAdopting the USDA Healthy Eating Habits

This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.

Sponsors

Blue Cross Blue Shield of Michigan Foundation
CollaboratorOTHER
Arbor Research Collaborative for Health
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Urination frequency on 3-day bladder diary2-weeksAverage number of times urinated per day on 3-day bladder diary

Secondary

MeasureTime frameDescription
Volume of urine per toileting event2-weeksAverage volume of urine per day with each toileting event on 3-day bladder diary
Daily urination urgency symptoms (Adapted from Bower et al 2001)2-weeksThe 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.
Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)2-weeksOn 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.
Bother associated with bladder symptoms (Coyne 2002)2-monthsThe 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.
Urination frequency on 3-day diary (longer-term effect)2-monthsAverage number of times urinated per day on 3-day bladder diary

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026