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

October 24, 2018 updated by: Loma Linda University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be exposed to 200 mg and 400 mg caffeine pills and placebo pills (free of caffeine). During each treatment period, participants will be required to avoid caffeine (except for the caffeine within the given treatment). The study is staged into 3 phases, which will last for 7 days each. After enrollment, participants will be asked to refrain from consuming any substances containing caffeine during the 21 days of treatment. Instead of coffee or other caffeine items, they will be exposed to caffeine in pill form. Participants will complete each treatment in a random, cross over blinded fashion. One phase of treatment will have participants consume two 200 mg-caffeine pills a day (total of 400 mg of caffeine/day), a second treatment will have participants consume one 200 mg-caffeine pill and one placebo pill a day. And the final treatment will have participants consume two placebo pills each day. Treatment phases will be assigned randomly to each participant. The participant will not know which phase they are receiving.

Prior to the treatment, the participant will be asked to fill out a detailed diet log of her eating and drinking habits. Participants will also be asked a series of questions on a survey related to bladder symptoms and mental health periodically throughout the study. It will take about 30 minutes of their time to answer the questionnaires at individual time points.

During the 21 days of the study period participants will be asked to self-monitor fluid intake and note any major changes of fluid intake compared to the initial intake log. They will be asked to conduct a 24-hour voiding and defecation log at two different time points within each treatment phase as well as prior to the study. 24-hour urine will be collected during each treatment phase at two different time points as well as prior to the study. Participants weight and lean body mass will be assessed in clinic using a Tanita scale at two times within each treatment phase and one time prior to the study

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Department of Urology, Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 400 mg of caffeine/day (Two 200mg pills/day)
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)
One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.
Active Comparator: 200 mg of caffeine/day (One 200mg pill and one placebo pill)
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)
This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)
Placebo Comparator: Two placebo pills/day
This arm will have participants consume two placebo pills each day.
Dietary supplement: Two placebo pills/day
This arm will have participants consume two placebo pills each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in voiding symptoms
Time Frame: Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.
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
Time Frame: Mental health symptoms will be measured 6 times throughout the 21-day trial, as well as a baseline measure one time pre-trial.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Andrea Staack, MD, Loma Linda University, Urology Medical Group, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 20, 2018

Study Completion (Actual)

September 20, 2018

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5130411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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