"The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"

NCT02180048 | Completed DMC

• 1 other identifier: 5130411
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe effects of caffeine on overactive bladder symptoms and wellbeing. This study looks at whether caffeine has bad effects on urinary symptoms or if lower doses of caffeine decrease the effects. The study will propose the following hypothesis:

1. 1.The voiding and mental health symptoms will be greatest in the high dose treatment and lowest in the placebo treatment.
2. 2.The low dose treatment will produce more voiding and mental health symptoms than the placebo treatment.
3. 3.Voiding and mental health symptoms will be mediated by hydration status of the patient which will be assessed using a Tanita Scale.

Conditions

Overactive Bladder; Caffeine; Menopause

Outcome Measures

Primary Outcomes (2)

• Change in voiding symptoms

  Voiding symptoms will be measured through a composite of self-reported surveys. These surveys are the King's Health Questionnaire, Urinary Distress Inventory, Overactive Bladder Symptom Score, Overactive Bladder Questionnaire.

  Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.

• Change in mental health

  Mental health symptoms will be measured through a composite of self-reported surveys. These surveys are the Insomnia Severity Index, Stress Quiz, Beck Anxiety Index, Beck Depression Inventory, The Positive and Negative Affect Scales, Rosenberg Self-Esteem Scale, and the International Physical Activity Questionnaire.

  Mental health symptoms will be measured 6 times throughout the 21-day trial, as well as a baseline measure one time pre-trial.

Study Arms (3)

400 mg of caffeine/day (Two 200mg pills/day)

ACTIVE COMPARATOR

One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.

Dietary Supplement: 400 mg of caffeine/day (Two 200mg pills/day)

200 mg of caffeine/day (One 200mg pill and one placebo pill)

ACTIVE COMPARATOR

This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)

Dietary Supplement: 200 mg of caffeine/day (One 200mg pill and one placebo pill)

Two placebo pills/day

PLACEBO COMPARATOR

This arm will have participants consume two placebo pills each day.

Dietary Supplement: Two placebo pills/day

Interventions

400 mg of caffeine/day (Two 200mg pills/day) DIETARY_SUPPLEMENT

One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.

400 mg of caffeine/day (Two 200mg pills/day)

200 mg of caffeine/day (One 200mg pill and one placebo pill) DIETARY_SUPPLEMENT

This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)

200 mg of caffeine/day (One 200mg pill and one placebo pill)

Two placebo pills/day DIETARY_SUPPLEMENT

This arm will have participants consume two placebo pills each day.

Two placebo pills/day

Eligibility Criteria

• Age: 58 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low to moderate coffee drinkers (between 1-3 cups/day, or 50-450mg caffeine/d)
• Able to communicate and read in English
• years of age or older
• Post-menopausal

You may not qualify if:

• Excessive coffee drinkers (\>450 mg/d)
• Individual who do not regularly consume caffeine
• Uncontrolled hypertension
• Vaginal pain
• Chronic pelvic pain/ Interstitial cystitis
• Pre- or perimenopausal

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Department of Urology, Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (1)

• Staack A, Distelberg B, Moldovan C, Belay RE, Sabate J. The Impact of Caffeine Intake on Mental Health Symptoms in Postmenopausal Females with Overactive Bladder Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial. J Womens Health (Larchmt). 2022 Jun;31(6):819-825. doi: 10.1089/jwh.2021.0467. Epub 2022 Apr 1.

  PMID: 35363563 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Staack, MD

  Loma Linda University, Urology Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

US (1)