search
Back to results

Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS)

Primary Purpose

Overactive Bladder, Urinary Urgency, Urinary Bladder, Overactive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reducing Potentially Irritating Beverages
Adopting the USDA Healthy Eating Habits
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Michigan School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduce Potentially Irritating Beverages

Adopt Healthy Eating Habits

Arm 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.

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

Outcomes

Primary Outcome Measures

Urination frequency on 3-day bladder diary
Average number of times urinated per day on 3-day bladder diary

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2018
Last Updated
November 12, 2019
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation, Arbor Research Collaborative for Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03625492
Brief Title
Fluids Affecting Bladder Urgency and Lower Urinary Symptoms
Acronym
FABULUS
Official Title
Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation, Arbor Research Collaborative for Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Urgency, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Caffeine, Alcohol Drinking, Lower Urinary Tract Symptoms
Keywords
artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduce Potentially Irritating Beverages
Arm Type
Experimental
Arm 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.
Arm Title
Adopt Healthy Eating Habits
Arm Type
Active Comparator
Arm Description
This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
Intervention Type
Behavioral
Intervention Name(s)
Reducing Potentially Irritating Beverages
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Adopting the USDA Healthy Eating Habits
Intervention Description
This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
Primary Outcome Measure Information:
Title
Urination frequency on 3-day bladder diary
Description
Average number of times urinated per day on 3-day bladder diary
Time Frame
2-weeks
Secondary Outcome Measure Information:
Title
Volume of urine per toileting event
Description
Average volume of urine per day with each toileting event on 3-day bladder diary
Time Frame
2-weeks
Title
Daily urination urgency symptoms (Adapted from Bower et al 2001)
Description
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.
Time Frame
2-weeks
Title
Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)
Description
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."
Time Frame
2-weeks
Title
Bother associated with bladder symptoms (Coyne 2002)
Description
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.
Time Frame
2-months
Title
Urination frequency on 3-day diary (longer-term effect)
Description
Average number of times urinated per day on 3-day bladder diary
Time Frame
2-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis M Miller, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Megan O Schimpf, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Nursing
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11696802
Citation
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.
Results Reference
background
PubMed Identifier
12206577
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. doi: 10.1023/a:1016370925601.
Results Reference
background
PubMed Identifier
14595606
Citation
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.
Results Reference
background

Learn more about this trial

Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

We'll reach out to this number within 24 hrs