Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

Overactive Bladder Clinical Trial

— FABULUS  

Official title:

Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625492
• Other study ID #: HUM00148419
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: November 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Adopting the USDA Healthy Eating Habits
This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Arbor Research Collaborative for Health, Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

De Wachter S, Wyndaele JJ. Frequency-volume charts: a tool to evaluate bladder sensation. Neurourol Urodyn. 2003;22(7):638-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urination frequency on 3-day bladder diary	Average number of times urinated per day on 3-day bladder diary	2-weeks
Secondary	Volume of urine per toileting event	Average volume of urine per day with each toileting event on 3-day bladder diary	2-weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Urination frequency on 3-day diary (longer-term effect)	Average number of times urinated per day on 3-day bladder diary	2-months