Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

NCT ID: NCT03625492

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2019-09-17

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduce Potentially Irritating Beverages

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.

Group Type: EXPERIMENTAL

Reducing Potentially Irritating Beverages

Intervention Type: 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.

Adopt Healthy Eating Habits

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

Group Type: ACTIVE_COMPARATOR

Adopting the USDA Healthy Eating Habits

Intervention Type: BEHAVIORAL

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

Interventions

Reducing Potentially Irritating Beverages

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

Adopting the USDA Healthy Eating Habits

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role: collaborator

Arbor Research Collaborative for Health

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Janis Miller

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janis M Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Megan O Schimpf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Nursing

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11696802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12206577 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14595606 (View on PubMed)

Other Identifiers

HUM00148419

Identifier Type: -

Identifier Source: org_study_id