An interventional study of Reducing Potentially Irritating Beverages and Adopting the USDA Healthy Eating Habits in Overactive Bladder, Urinary Urgency and Urinary Bladder, Overactive, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 65 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
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 them the USDA guidelines for healthy eating.
Behavioral: Adopting the USDA Healthy Eating Habits
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.
Urination frequency on 3-day bladder diary
Average number of times urinated per day on 3-day bladder diary
Time frame: 2-weeks
Volume of urine per toileting event
Average volume of urine per day with each toileting event on 3-day bladder diary
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 2-months
Urination frequency on 3-day diary (longer-term effect)
Average number of times urinated per day on 3-day bladder diary
Time frame: 2-months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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