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

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ClinicalTrials.gov Identifier: NCT02180048
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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. 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Caffeine Menopause Dietary Supplement: 400 mg of caffeine/day (Two 200mg pills/day) Dietary Supplement: 200 mg of caffeine/day (One 200mg pill and one placebo pill) Dietary Supplement: Two placebo pills/day Not Applicable

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  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: "The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
Study Start Date : July 2014
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   58 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180048


Locations
United States, California
Department of Urology, Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Andrea Staack, MD Loma Linda University, Urology Medical Group, Inc.

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02180048     History of Changes
Other Study ID Numbers: 5130411
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents