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Completed

NCT Number: NCT03625492

Fluids Affecting Bladder Urgency and Lower Urinary 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.

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Key information

Conditions

Overactive Bladder Alcohol Drinking Behavior Caffeine Drinking Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urinary Urgency Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reducing Potentially Irritating Beverages

Behavioral

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

Behavioral

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

Primary outcomes

  1. Urination frequency on 3-day bladder diary

    Time frame: 2-weeks

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

Secondary outcomes

  1. Volume of urine per toileting event

    Time frame: 2-weeks

    Average volume of urine per day with each toileting event on 3-day bladder diary

  2. Daily urination urgency symptoms (Adapted from Bower et al 2001)

    Time frame: 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.

  3. Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)

    Time frame: 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."

  4. Bother associated with bladder symptoms (Coyne 2002)

    Time frame: 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.

  5. Urination frequency on 3-day diary (longer-term effect)

    Time frame: 2-months

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Arbor Research Collaborative for Health
  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Official study title

Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms

Acronym: FABULUS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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