Clinical trial NCT03625492: Fluids Affecting Bladder Urgency and Lower Urinary Symptoms
Official title: Effect of Potentially Irritating Beverages on Overactive Bladder Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
name: Arbor Research Collaborative for Health
First posted: 2018-08-10
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urination frequency on 3-day bladder diary
timeFrame: 2-weeks
Secondary outcomes:
measure: Volume of urine per toileting event
timeFrame: 2-weeks
measure: Daily urination urgency symptoms (Adapted from Bower et al 2001)
timeFrame: 2-weeks
measure: Perception of bladder fullness relative to urination delay ability (DeWachter, 2003)
timeFrame: 2-weeks
measure: Bother associated with bladder symptoms (Coyne 2002)
timeFrame: 2-months
measure: Urination frequency on 3-day diary (longer-term effect)
timeFrame: 2-months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan
name: Janis M Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Megan O Schimpf, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.