Clinical trial NCT02180048: "The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
Official title: "The Effects of Caffeine on Overactive Bladder Symptoms and Mental Health in Postmenopausal Women"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Caffeine
Menopause
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 55
Sex: FEMALE
Minimum age (years): 58
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility 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

Primary outcomes:
measure: Change in voiding symptoms
timeFrame: Voiding symptoms surveys will be completed 6 times throughout the 21-day trial, in addition to a baseline measurement pre-trial.
measure: Change in mental health
timeFrame: Mental health symptoms will be measured 6 times throughout the 21-day trial, as well as a baseline measure one time pre-trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Department of Urology, Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University, Urology Medical Group, Inc.
name: Andrea Staack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.