Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduce 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.	Behavioral: 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.
Active Comparator: Adopt Healthy Eating Habits; This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.	Behavioral: Adopting the USDA Healthy Eating Habits; This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urination frequency on 3-day bladder diary	Average number of times urinated per day on 3-day bladder diary	2-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of urine per toileting event	Average volume of urine per day with each toileting event on 3-day bladder diary	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.	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."	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.	2-months
Urination frequency on 3-day diary (longer-term effect)	Average number of times urinated per day on 3-day bladder diary	2-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Arbor Research Collaborative for Health; Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Janis M Miller, PhD, University of Michigan; Principal Investigator: Megan O Schimpf, MD, University of Michigan

Publications and helpful links

General Publications

• Coyne 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.
• 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.
• De 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: overactive bladder; caffeine; lower urinary tract symptoms; urinary urgency; alcohol drinking; artificial sweeteners; urinary incontinence, urge
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Drinking Behavior; Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urination Disorders; Elimination Disorders; Alcohol Drinking; Urinary Bladder, Overactive; Urinary Incontinence; Lower Urinary Tract Symptoms; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: HUM00148419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No