Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

Not Applicable

Completed

• Conditions: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Overactive Bladder; Caffeine; Alcohol Drinking; Urinary Urgency; Urinary Incontinence, Urge
• Interventions: Behavioral: Adopting the USDA Healthy Eating Habits; Behavioral: Reducing Potentially Irritating Beverages

• Registration Number: NCT03625492
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adopt Healthy Eating Habits	Adopting the USDA Healthy Eating Habits	This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
Reduce Potentially Irritating Beverages	Reducing 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.

Primary Outcome Measures

Name	Time	Method
Urination frequency on 3-day bladder diary	2-weeks	Average number of times urinated per day on 3-day bladder diary

Secondary Outcome Measures

Name	Time	Method
Daily urination urgency symptoms (Adapted from Bower et al 2001)	2-weeks	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.
Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)	2-weeks	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."
Bother associated with bladder symptoms (Coyne 2002)	2-months	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.
Urination frequency on 3-day diary (longer-term effect)	2-months	Average number of times urinated per day on 3-day bladder diary
Volume of urine per toileting event	2-weeks	Average volume of urine per day with each toileting event on 3-day bladder diary

Trial Locations

Locations (1)

University of Michigan School of Nursing; 🇺🇸 Ann Arbor, Michigan, United States