Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS)

University of Michigan

Status: Completed

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

Treatments: Behavioral: Reducing Potentially Irritating Beverages; Behavioral: Adopting the USDA Healthy Eating Habits

Study type: Interventional

Funder types: Other

Identifiers

NCT03625492

HUM00148419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Reduce Potentially Irritating Beverages

Experimental group

Description:

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.

Treatment:

Behavioral: Reducing Potentially Irritating Beverages

Adopt Healthy Eating Habits

Active Comparator group

Description:

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

Treatment:

Behavioral: Adopting the USDA Healthy Eating Habits