Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms

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

Intervention / Treatment
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* Behavioral: Reducing Potentially Irritating Beverages
* Behavioral: Adopting the USDA Healthy Eating Habits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduce Potentially Irritating Beverages<br>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<br>* 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.<br>|
| Active Comparator: Adopt Healthy Eating Habits<br>This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating. | Behavioral: Adopting the USDA Healthy Eating Habits<br>* This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial sweeteners, caffeine, alcohol drinking, urinary urgency, overactive bladder, urinary incontinence, urge, lower urinary tract symptoms