Fluids Affecting Bladder Urgency and Lower Urinary Symptoms

NCT03625492 | Completed

• 1 other identifier: HUM00148419
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Urination frequency on 3-day bladder diary

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

  2-weeks

Secondary Outcomes (5)

• Volume of urine per toileting event

  2-weeks

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

  2-weeks

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

  2-weeks

• Bother associated with bladder symptoms (Coyne 2002)

  2-months

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

  2-months

Study Arms (2)

Reduce Potentially Irritating Beverages

EXPERIMENTAL

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

Adopt Healthy Eating Habits

ACTIVE COMPARATOR

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

Behavioral: Adopting the USDA Healthy Eating Habits

Interventions

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.

Reduce Potentially Irritating Beverages

Adopting the USDA Healthy Eating Habits BEHAVIORAL

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

Adopt Healthy Eating Habits

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator
• Arbor Research Collaborative for Health: collaborator

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 11696802 BACKGROUND

• 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.

  PMID: 12206577 BACKGROUND

• 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.

  PMID: 14595606 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Drinking Behavior; Behavior

Study Officials

• Janis M Miller, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Megan O Schimpf, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: August 7, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (1)